Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-05 @ 6:30 AM
Study NCT ID:
NCT04617795
Status:
COMPLETED
Last Update Posted:
2025-04-18
First Post:
2020-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tly@insulet.com', 'phone': '9786007628', 'title': 'Dr. Trang Ly', 'organization': 'Insulet Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Start of standard therapy (-14d to +1d prior to OP5 start) until the end of the extension [251 days +/- 3 days].', 'description': 'Adverse events listed below were collected from the start of standard therapy until the end of the extension.', 'eventGroups': [{'id': 'EG000', 'title': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Basal-Bolus (Group A Extension)', 'description': '• 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Basal (Group B Extension)', 'description': '• 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Prolonged Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hyperglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}, {'id': 'OG001', 'title': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}], 'classes': [{'title': 'Overall ST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.5', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '23.8', 'groupId': 'OG001'}]}]}, {'title': 'Overall AUTO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'Overall Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.4', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8-10 weeks and after 6-month optional extension', 'description': 'Overall percentage of time ≥250 mg/dL during standard therapy phase and ALL phases of Automated Mode', 'unitOfMeasure': 'Percent of Time (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Group B, only 10 subjects completed the extension study.'}, {'type': 'PRIMARY', 'title': 'Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}, {'id': 'OG001', 'title': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}], 'classes': [{'title': 'Overall ST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Overall AUTO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Overall Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8-10 weeks and after 6-month optional extension', 'description': 'Overall percentage of time \\<54 mg/dL during standard therapy phase and all phases of Automated Mode', 'unitOfMeasure': 'Percent of Time (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Group B, only 10 subjects completed the extension study.'}, {'type': 'SECONDARY', 'title': 'Percent of Time in Range 70-180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}, {'id': 'OG001', 'title': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}], 'classes': [{'title': 'Overall ST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.8', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '30.5', 'spread': '17.4', 'groupId': 'OG001'}]}]}, {'title': 'Overall AUTO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.5', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '56.6', 'spread': '17.7', 'groupId': 'OG001'}]}]}, {'title': 'Overall Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.1', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '65.3', 'spread': '15.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Glucose metric from study continuous glucose monitoring system', 'unitOfMeasure': 'Percent of Time (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Group B, only 10 participants completed the extension.'}, {'type': 'SECONDARY', 'title': 'Percent of Time > 180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}, {'id': 'OG001', 'title': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}], 'classes': [{'title': 'Overall ST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.3', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '69.2', 'spread': '17.6', 'groupId': 'OG001'}]}]}, {'title': 'Overall AUTO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.3', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '43.3', 'spread': '17.7', 'groupId': 'OG001'}]}]}, {'title': 'Overall Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.8', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '34.5', 'spread': '15.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Glucose metric from study continuous glucose monitoring system', 'unitOfMeasure': 'Percent of Time (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Group B, only 10 participants completed the extension.'}, {'type': 'SECONDARY', 'title': 'Percent of Time ≥ 300 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}, {'id': 'OG001', 'title': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}], 'classes': [{'title': 'Overall ST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '17.3', 'groupId': 'OG001'}]}]}, {'title': 'Overall AUTO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Overall Exension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Glucose metric from study continuous glucose monitoring system', 'unitOfMeasure': 'Percent of Time (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Group B, only 10 participants completed the extension.'}, {'type': 'SECONDARY', 'title': 'Percent of Time < 70 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}, {'id': 'OG001', 'title': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}], 'classes': [{'title': 'Overall ST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.91', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Overall AUTO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Overall Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Glucose metric from study continuous glucose monitoring system', 'unitOfMeasure': 'Percent of Time (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Group B, only 10 participants completed the extension.'}, {'type': 'SECONDARY', 'title': 'Standard Deviation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}, {'id': 'OG001', 'title': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}], 'classes': [{'title': 'Overall ST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.3', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '61.2', 'spread': '16.2', 'groupId': 'OG001'}]}]}, {'title': 'Overall AUTO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.0', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '49.6', 'spread': '14.1', 'groupId': 'OG001'}]}]}, {'title': 'Overall Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.7', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '43.6', 'spread': '9.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Glucose metric from study continuous glucose monitoring system-measured glucose variability with the standard deviation', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Group B, only 10 participants completed the extension.'}, {'type': 'SECONDARY', 'title': 'Coefficient of Variation (of Glucose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}, {'id': 'OG001', 'title': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}], 'classes': [{'title': 'Overall ST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.2', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '27.6', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Overall AUTO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.3', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '27.0', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Overall Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.0', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '25.6', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period.', 'unitOfMeasure': 'Percent coefficient of variation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Group B, only 10 subjects completed the extension.'}, {'type': 'SECONDARY', 'title': 'Mean Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}, {'id': 'OG001', 'title': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}], 'classes': [{'title': 'Overall ST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '199.1', 'spread': '32.5', 'groupId': 'OG000'}, {'value': '224.6', 'spread': '40.9', 'groupId': 'OG001'}]}]}, {'title': 'Overall AUTO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '175.5', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '181.9', 'spread': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Overall Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '180.7', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '169.6', 'spread': '16.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Glucose metric from study continuous glucose monitoring system', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Group B, only 10 participants completed the extension.'}, {'type': 'SECONDARY', 'title': 'Total Daily Insulin (Units)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}, {'id': 'OG001', 'title': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}], 'classes': [{'title': 'ST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.4', 'spread': '44.0', 'groupId': 'OG000'}, {'value': '30.6', 'spread': '21.9', 'groupId': 'OG001'}]}]}, {'title': 'AUTO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.1', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '42.1', 'spread': '38.4', 'groupId': 'OG001'}]}]}, {'title': 'Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.7', 'spread': '28.5', 'groupId': 'OG000'}, {'value': '38.7', 'spread': '33.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Measure of insulin requirements', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Group B, only 10 participants completed the extension.'}, {'type': 'SECONDARY', 'title': 'Total Daily Insulin (Units/kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}, {'id': 'OG001', 'title': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}], 'classes': [{'title': 'ST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'AUTO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Measure of insulin requirements', 'unitOfMeasure': 'units/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Group B, only 10 subjects completed the extension.'}, {'type': 'SECONDARY', 'title': 'Change in Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}, {'id': 'OG001', 'title': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'End of Main Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'End of Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of study (8-10 weeks) and during extension (21-23 weeks and 24-26 weeks) compared to baseline (Days 57, 147, and 237 (Group A) or Days 71, 161, and 251 (Group B) compared to Day -30', 'description': 'Measures average blood sugar levels over the past 3 months', 'unitOfMeasure': 'Percentage of HbA1C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In Group B, only 10 participants completed the extension.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}, {'id': 'FG001', 'title': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}], 'periods': [{'title': 'Main Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Optional 6-month Extension', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}, {'id': 'BG001', 'title': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode\n\nOmnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.7', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '59.4', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '60.6', 'spread': '8.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '35.19', 'spread': '4.53', 'groupId': 'BG000'}, {'value': '31.88', 'spread': '3.84', 'groupId': 'BG001'}, {'value': '33.54', 'spread': '4.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-27', 'size': 286246, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-15T09:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2022-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2020-11-02', 'resultsFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2020-11-02', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-16', 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hyperglycemia', 'timeFrame': '8-10 weeks and after 6-month optional extension', 'description': 'Overall percentage of time ≥250 mg/dL during standard therapy phase and ALL phases of Automated Mode'}, {'measure': 'Hypoglycemia', 'timeFrame': '8-10 weeks and after 6-month optional extension', 'description': 'Overall percentage of time \\<54 mg/dL during standard therapy phase and all phases of Automated Mode'}], 'secondaryOutcomes': [{'measure': 'Percent of Time in Range 70-180 mg/dL', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Glucose metric from study continuous glucose monitoring system'}, {'measure': 'Percent of Time > 180 mg/dL', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Glucose metric from study continuous glucose monitoring system'}, {'measure': 'Percent of Time ≥ 300 mg/dL', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Glucose metric from study continuous glucose monitoring system'}, {'measure': 'Percent of Time < 70 mg/dL', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Glucose metric from study continuous glucose monitoring system'}, {'measure': 'Standard Deviation', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Glucose metric from study continuous glucose monitoring system-measured glucose variability with the standard deviation'}, {'measure': 'Coefficient of Variation (of Glucose)', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period.'}, {'measure': 'Mean Glucose', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Glucose metric from study continuous glucose monitoring system'}, {'measure': 'Total Daily Insulin (Units)', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Measure of insulin requirements'}, {'measure': 'Total Daily Insulin (Units/kg)', 'timeFrame': 'Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B', 'description': 'Measure of insulin requirements'}, {'measure': 'Change in Hemoglobin A1c (HbA1c)', 'timeFrame': 'End of study (8-10 weeks) and during extension (21-23 weeks and 24-26 weeks) compared to baseline (Days 57, 147, and 237 (Group A) or Days 71, 161, and 251 (Group B) compared to Day -30', 'description': 'Measures average blood sugar levels over the past 3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['T2D', 'Omnipod'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The study subjects will be separated into 2 groups, depending on their previous insulin therapy with approximately 50% of subjects from each group, continuous glucose monitoring (CGM) naive.\n\nGroup A will complete a 2-week Standard Therapy Phase followed by 8 weeks of Omnipod 5 system use.\n\nGroup B will complete a 2-week Standard Therapy Phase followed by 10 weeks of Omnipod 5 system use.\n\nGroup A and Group B will have an optional 6-month extension of Omnipod 5 system use', 'detailedDescription': 'Basal-Bolus - Group A (N=12)\n\n* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 continuous glucose monitoring (CGM) , followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode\n\nBasal - Group B (N=12)\n\n* 2 weeks standard therapy - using basal injection only and Dexcom G6 continuous glucose monitoring (CGM) , followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 continuous glucose monitoring (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age at time of consent 18-75 years\n2. Diagnosed with type 2 diabetes on insulin therapy by injection: basal-bolus (12 subjects) or basal only (12 subjects) regimens\n3. A1C 8.0-12.0%\n4. Has not used an insulin pump within 3 months of screening\n5. Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog or Apidra during the study\n6. Maximum insulin dose of 200 units/day\n7. Stable doses over the last 4 weeks of other glucose-lowering medications as determined by Investigator\n8. Willing to wear the system continuously throughout the study\n9. Deemed appropriate for pump therapy per investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities\n10. Investigator has confidence that the subject has the cognitive ability and can successfully operate all study devices and can adhere to the protocol\n11. Must be willing to use the Dexcom App on the Omnipod 5 PDM as the sole source of Dexcom data (except for the Dexcom Follow App) during Automated Mode\n12. Subjects scoring ≥ 4 on the Clarke Questionnaire must agree to have an overnight companion, defined as someone who resides in the same home or building as the study subject and who can be available overnight\n13. Able to read and speak English fluently\n14. Willing and able to sign the Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n1. A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk\n2. Planned major surgery during the study\n3. History of severe hypoglycemia in the past 6 months\n4. History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis\n5. Diagnosed with a blood dyscrasia or bleeding disorder\n6. Plans to receive blood transfusion over the course of the study\n7. Currently diagnosed with anorexia nervosa or bulimia\n8. Currently on hemodialysis\n9. History of adrenal insufficiency\n10. Has taken oral or injectable steroids within the past 8-weeks or plans to take oral or injectable steroids during the study\n11. Unable to tolerate adhesive tape or has any unresolved skin condition in sensor or pump placement\n12. Plans to use insulin other than U-100 insulin during the Omnipod 5 phase of the study\n13. Cardiac disease with functional status New York Heart Association Class III or IV or current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12-months.\n14. Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD, or implant)\n15. Participation in another clinical study using an investigational drug or device other than the Omnipod 5 in the preceding 30-days or intends to participate during the study period\n16. Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment"}, 'identificationModule': {'nctId': 'NCT04617795', 'briefTitle': 'Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Insulet Corporation'}, 'officialTitle': 'Evaluating the Safety and Effectiveness of the Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'OP5 in T2D Study G190270'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Basal-Bolus (Group A)', 'description': '* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus\n* 6-month optional extension using Automated Mode', 'interventionNames': ['Device: Omnipod 5 Automated Insulin Delivery System']}, {'type': 'EXPERIMENTAL', 'label': 'Basal (Group B)', 'description': '* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by:\n* 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by:\n* 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by:\n\n * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR\n * If % time in range 70-180 mg/dL during Automated Mode is \\>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus\n* 6-month optional extension using Automated Mode', 'interventionNames': ['Device: Omnipod 5 Automated Insulin Delivery System']}], 'interventions': [{'name': 'Omnipod 5 Automated Insulin Delivery System', 'type': 'DEVICE', 'description': 'The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).\n\nThe Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.\n\nThe Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.', 'armGroupLabels': ['Basal (Group B)', 'Basal-Bolus (Group A)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90022', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Diabetes', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'International Diabetes Center', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}], 'overallOfficials': [{'name': 'Anders Carlson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'International Diabetes Center at Park Nicollet'}, {'name': 'Anne Peters, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Keck School of Medicine of USC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insulet Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}