Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT02985866
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2016-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The International Diabetes Closed Loop (iDCL) Trial: Protocol 1
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Italy', 'Netherlands'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D019397', 'term': 'Pancreas, Artificial'}], 'ancestors': [{'id': 'D001187', 'term': 'Artificial Organs'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mc7m@virginia.edu', 'phone': '434-982-0602', 'title': 'Boris Kovatchev, PhD', 'organization': 'University of Virginia Center for Diabetes Technology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '13 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Artificial Pancreas (Closed Loop Control)', 'description': 'Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.\n\nArtificial Pancreas: Use of CTR at home for 3 months', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Sensor Augmented Therapy', 'description': 'Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.\n\nSensor Augmented Therapy: Use of personal pump with study CGM \\& glucometer at home for 3 months', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 2, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastroenteritis', 'notes': 'Nausea \\& vomiting started 02/13/18. No fever. Exposed GI illness day before. Blood glucose=99 mg/dl; serum ketones=1.2 mmol/L. In follow up call, ketones=1.1 mmol/L one hour later. On 02/14/18, ketones=0.3 mmol/L. Complete recovery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery', 'notes': 'Planned in-patient surgery on 4/10/18. Removal of Whartin growth behind left ear. Complete recovery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hypoglycemic seizure', 'notes': "Severe hypoglycemia on 2/26/18 at \\~5:30PM. Spouse noticed convulsion during sleep CGM reading = 50 mg/dl. Spouse provided two boxes of juice \\& glucose tablets. Participant doesn't recall episode. Complete recovery after rescue carbohydrates.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'notes': 'Participant ran 100k race on 5/12/18.Felt overheated \\& vomiting x2 after 52.8 miles (13.5h run time). Admitted to the ER for dehydration \\& DKA risk. BG in 200s \\& ketones were negative. Complete recovery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time Below 70 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Artificial Pancreas (Closed Loop Control)', 'description': 'Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.\n\nArtificial Pancreas: Use of CTR at home for 3 months'}, {'id': 'OG001', 'title': 'Sensor Augmented Therapy', 'description': 'Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.\n\nSensor Augmented Therapy: Use of personal pump with study CGM \\& glucometer at home for 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'To address the issue of multiple comparisons with 2 primary outcomes, the intervention was considered effective only if both co-primary outcomes were statistically significant at 5% level. P value for noninferiority NI (prespecified NI limit = 5%).', 'groupDescription': 'Statistical analyses were performed on an intention-to-treat basis, and all participants with any amount of post randomization data were included in all analyses.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.', 'nonInferiorityComment': 'The first co-primary end point was superiority of CLC over SAP in terms of CGM-measured time below 70 mg/dL. The treatment groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect. Missing baseline data were handled by direct likelihood method. Model residuals were confirmed to be approximately normally distributed.'}], 'paramType': 'MEAN', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority)', 'unitOfMeasure': 'percentage of total CGM time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time Above 180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Artificial Pancreas (Closed Loop Control)', 'description': 'Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.\n\nArtificial Pancreas: Use of CTR at home for 3 months'}, {'id': 'OG001', 'title': 'Sensor Augmented Therapy', 'description': 'Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.\n\nSensor Augmented Therapy: Use of personal pump with study CGM \\& glucometer at home for 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '11', 'groupId': 'OG000'}, {'value': '39', 'spread': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'To address the issue of multiple comparisons with 2 primary outcomes, the intervention was considered effective only if both co-primary outcomes were statistically significant at 5% level. P value for noninferiority NI (prespecified NI limit = 5%).', 'groupDescription': 'Statistical analyses were performed on an intention-to-treat basis, and all participants with any amount of post randomization data were included in all analyses.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.', 'nonInferiorityComment': 'The second co-primary end point was noninferiority in CGM-measured time above 180 mg/dL, with a noninferiority limit of 5%. The treatment groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect. Missing baseline data were handled by direct likelihood method. Model residuals were confirmed to be approximately normally distributed.'}], 'paramType': 'MEAN', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority)', 'unitOfMeasure': 'percentage of total CGM time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Below 54 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Artificial Pancreas', 'description': 'Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.\n\nArtificial Pancreas: Use of CTR at home for 3 months'}, {'id': 'OG001', 'title': 'Sensor Augmented Therapy', 'description': 'Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.\n\nSensor Augmented Therapy: Use of personal pump with study CGM \\& glucometer at home for 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.', 'groupDescription': 'Same as for the primary outcomes', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.', 'nonInferiorityComment': 'Same as for primary outcome 1'}], 'paramType': 'MEAN', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'Percent time CGM readings were below 54 mg/dL', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Below 60 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Artificial Pancreas (Closed Loop Control)', 'description': 'Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.\n\nArtificial Pancreas: Use of CTR at home for 3 months'}, {'id': 'OG001', 'title': 'Sensor Augmented Therapy', 'description': 'Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.\n\nSensor Augmented Therapy: Use of personal pump with study CGM \\& glucometer at home for 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.', 'groupDescription': 'Same as for the primary outcomes', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.', 'nonInferiorityComment': 'Same as for primary outcome 1'}], 'paramType': 'MEAN', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured % time below 60 mg/dL', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time in Range 70-180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Artificial Pancreas (Closed Loop Control)', 'description': 'Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.\n\nArtificial Pancreas: Use of CTR at home for 3 months'}, {'id': 'OG001', 'title': 'Sensor Augmented Therapy', 'description': 'Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.\n\nSensor Augmented Therapy: Use of personal pump with study CGM \\& glucometer at home for 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '11', 'groupId': 'OG000'}, {'value': '57', 'spread': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.', 'groupDescription': 'Same as for the primary outcomes', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.', 'nonInferiorityComment': 'Same as for primary outcome 1'}], 'paramType': 'MEAN', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured % in range 70-180 mg/dL', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time in Range 70-140 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Artificial Pancreas (Closed Loop Control)', 'description': 'Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.\n\nArtificial Pancreas: Use of CTR at home for 3 months'}, {'id': 'OG001', 'title': 'Sensor Augmented Therapy', 'description': 'Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.\n\nSensor Augmented Therapy: Use of personal pump with study CGM \\& glucometer at home for 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'spread': '10', 'groupId': 'OG000'}, {'value': '35', 'spread': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.', 'groupDescription': 'Same as for the primary outcomes', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.', 'nonInferiorityComment': 'Same as for primary outcome 1'}], 'paramType': 'MEAN', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured % time in range 70-140 mg/dL', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Above 250 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Artificial Pancreas (Closed Loop Control)', 'description': 'Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.\n\nArtificial Pancreas: Use of CTR at home for 3 months'}, {'id': 'OG001', 'title': 'Sensor Augmented Therapy', 'description': 'Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.\n\nSensor Augmented Therapy: Use of personal pump with study CGM \\& glucometer at home for 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '11.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.', 'groupDescription': 'Same as for the primary outcomes', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.', 'nonInferiorityComment': 'Same as for primary outcome 1'}], 'paramType': 'MEAN', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured % time above 250 mg/dL', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Above 300 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Artificial Pancreas (Closed Loop Control)', 'description': 'Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.\n\nArtificial Pancreas: Use of CTR at home for 3 months'}, {'id': 'OG001', 'title': 'Sensor Augmented Therapy', 'description': 'Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.\n\nSensor Augmented Therapy: Use of personal pump with study CGM \\& glucometer at home for 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '7.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.', 'groupDescription': 'Same as for the primary outcomes', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.', 'nonInferiorityComment': 'Same as for primary outcome 1'}], 'paramType': 'MEAN', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured % time above 300 mg/dL', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Coefficient of Variation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Artificial Pancreas (Closed Loop Control)', 'description': 'Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.\n\nArtificial Pancreas: Use of CTR at home for 3 months'}, {'id': 'OG001', 'title': 'Sensor Augmented Therapy', 'description': 'Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.\n\nSensor Augmented Therapy: Use of personal pump with study CGM \\& glucometer at home for 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '5', 'groupId': 'OG000'}, {'value': '38', 'spread': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.', 'groupDescription': 'Same as for the primary outcomes', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.', 'nonInferiorityComment': 'Same as for primary outcome 1'}], 'paramType': 'MEAN', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured coefficient of variation (CV)', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Artificial Pancreas (Closed Loop Control)', 'description': 'Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.\n\nArtificial Pancreas: Use of CTR at home for 3 months'}, {'id': 'FG001', 'title': 'Sensor Augmented Therapy', 'description': 'Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.\n\nSensor Augmented Therapy: Use of personal pump with study CGM \\& glucometer at home for 3 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Poor CGM data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This parallel-group, multicenter, randomized unblinded clinical trial was conducted at 7 US university centers. Participants were diagnosed with type 1 diabetes, treated with insulin for at least 1 year, using pump therapy for at least 6 months, age 14 and above, \\& HbA1c \\<10.5% (91 mmol/mol). A study goal was to have at least 50 participants with HbA1c\\<7.5% (58 mmol/mol) and at least 50 participants with HbA1c \\>7.5% (58 mmol/mol). Participants were screened October 2017 - May 2018.', 'preAssignmentDetails': 'Participants who used a personal Dexcom G4 or G5 CGM pre-study for at least 21 of the prior 28 days proceeded directly to randomization. For these participants, the data downloaded from the personal CGM provided the 2-week baseline data. All others wore a blinded study CGM for 2 weeks to collect baseline data, followed by 2 weeks of training using an unblinded study CGM. Successful completion of the run-in was followed by randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Artificial Pancreas (Closed Loop Control)', 'description': 'Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.\n\nArtificial Pancreas: Use of CTR at home for 3 months'}, {'id': 'BG001', 'title': 'Sensor Augmented Therapy', 'description': 'Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.\n\nSensor Augmented Therapy: Use of personal pump with study CGM \\& glucometer at home for 3 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<21', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': '21 to <35', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': '35 to <65', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': '≥65', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '118', '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': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes duration at randomization (years)', 'classes': [{'title': '1 to <5', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': '5 to <10', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': '10 to <20', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': '20 to <30', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': '30 to <40', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': '≥40', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior CGM use', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'In past, but not current', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Current', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI at enrollment (kg/m2)', 'classes': [{'title': '<18', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': '18 to <25', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': '25 to <30', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': '≥30', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HbA1c at randomization: laboratory', 'classes': [{'title': '<7.0% (53 mmol/ml)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': '7.0% to <7.5% (53 to <58 mmol/mol)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': '7.5% to <8.0% (58 to <64 mmol/mol)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': '8.0% to ≤10.5% (64 to ≤91 mmol/mol)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'C-Peptide at randomization (nmol/L): Laboratory', 'classes': [{'title': '<0.003', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}, {'title': '0.003 to <0.1', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': '0.1 to <0.5', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': '≥0.5', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes ketoacidosis events in the last 12 months', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Severe hypoglycemic events in past 12 months', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-09', 'size': 1278169, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-26T16:34', 'hasProtocol': True}, {'date': '2018-04-06', 'size': 349689, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-05T14:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-08', 'studyFirstSubmitDate': '2016-12-05', 'resultsFirstSubmitDate': '2022-08-15', 'studyFirstSubmitQcDate': '2016-12-06', 'lastUpdatePostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-08', 'studyFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Below 70 mg/dL', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority)'}, {'measure': 'Time Above 180 mg/dL', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority)'}], 'secondaryOutcomes': [{'measure': 'Time Below 54 mg/dL', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'Percent time CGM readings were below 54 mg/dL'}, {'measure': 'Time Below 60 mg/dL', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured % time below 60 mg/dL'}, {'measure': 'Time in Range 70-180 mg/dL', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured % in range 70-180 mg/dL'}, {'measure': 'Time in Range 70-140 mg/dL', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured % time in range 70-140 mg/dL'}, {'measure': 'Time Above 250 mg/dL', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured % time above 250 mg/dL'}, {'measure': 'Time Above 300 mg/dL', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured % time above 300 mg/dL'}, {'measure': 'Coefficient of Variation', 'timeFrame': 'Post randomization (final 11 weeks)', 'description': 'CGM-measured coefficient of variation (CV)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Artificial Pancreas', 'Closed Loop Control', 'Continuous Glucose Monitor (CGM)', 'inControl Diabetes Management Platform'], 'conditions': ['Type1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '32245747', 'type': 'BACKGROUND', 'citation': 'Kovatchev B, Anderson SM, Raghinaru D, Kudva YC, Laffel LM, Levy C, Pinsker JE, Wadwa RP, Buckingham B, Doyle FJ 3rd, Brown SA, Church MM, Dadlani V, Dassau E, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Lum J, Beck RW; iDCL Study Group. Erratum. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care 2020;43:607-615. Diabetes Care. 2020 Jun;43(6):1366. doi: 10.2337/dc20-er06. Epub 2020 Apr 3. No abstract available.'}, {'pmid': '31937608', 'type': 'RESULT', 'citation': 'Kovatchev B, Anderson SM, Raghinaru D, Kudva YC, Laffel LM, Levy C, Pinsker JE, Wadwa RP, Buckingham B, Doyle FJ 3rd, Brown SA, Church MM, Dadlani V, Dassau E, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Lum J, Beck RW; iDCL Study Group. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care. 2020 Mar;43(3):607-615. doi: 10.2337/dc19-1310. Epub 2020 Jan 14.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system.', 'detailedDescription': 'The protocol is a 3-month parallel group multi-center randomized trial designed to compare Control-to-Range (CTR) closed-loop (CL) with sensor augmented pump therapy (SAP). Approximately 126 subjects will be entered into the randomized trial at approximately seven clinical sites in the United States, such that at least 110 subjects complete the randomized trial. A maximum of 200 subjects may be enrolled in the study in order to achieve the goal of randomizing 126 subjects.\n\nIn order to have a broad range of glycemic control among the subjects, a study goal will be to have a minimum of 50 subjects with HbA1c ≥ 7.5% and 50 with HbA1c \\< 7.5%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year\n2. Use of an insulin pump for at least 6 months\n3. Age ≥14 years old\n4. HbA1c level \\<10.5% at screening\n5. For females, not currently known to be pregnant\n6. Willingness not to add glucose-lowering agents (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) during the study\n7. Willingness, if not assigned to the closed-loop group, to avoid use of any closed-loop control system for the duration of the clinical trial\n8. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the unblinded study CGM is in use\n9. Willingness to establish network connectivity on at least a weekly basis either via local Wifi network or via a study-provided cellular service\n10. Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra)\n11. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol\n12. For subjects less than 18 years old, living with one or more parent/legal guardian (referred to subsequently as diabetes care partner) committed to participating in study training for emergency procedures for severe hypoglycemia and able to contact the subject in case of an emergency\n\nExclusion Criteria:\n\n1. Medical need for chronic acetaminophen\n2. Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) in the 3 months prior to enrollment\n3. Hemophilia or any other bleeding disorder\n4. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk including any contraindication to the use of any of the study devices per FDA labeling\n5. Participation in another pharmaceutical or device trial at the time of enrollment or during the study\n6. Use of a closed-loop system within the last month prior to enrollment\n7. Employed by, or having immediate family members employed by TypeZero Technologies, LLC'}, 'identificationModule': {'nctId': 'NCT02985866', 'acronym': 'iDCL', 'briefTitle': 'The International Diabetes Closed Loop (iDCL) Trial: Protocol 1', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial: A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor-Augmented Pump Therapy in the Management of Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'iDCL'}, 'secondaryIdInfos': [{'id': 'UC4DK108483', 'link': 'https://reporter.nih.gov/quickSearch/UC4DK108483', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Artificial Pancreas', 'description': 'Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes.', 'interventionNames': ['Device: Artificial Pancreas']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sensor Augmented Therapy', 'description': 'Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer.', 'interventionNames': ['Other: Sensor Augmented Therapy']}], 'interventions': [{'name': 'Artificial Pancreas', 'type': 'DEVICE', 'otherNames': ['Control-to-Range (CTR) closed-loop (CL)'], 'description': 'Use of CTR at home for 3 months', 'armGroupLabels': ['Artificial Pancreas']}, {'name': 'Sensor Augmented Therapy', 'type': 'OTHER', 'otherNames': ['SAP'], 'description': 'Use of personal pump with study CGM \\& glucometer at home for 3 months', 'armGroupLabels': ['Sensor Augmented Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'William Sansum Diabetes Center', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center, University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard University (Joslin Diabetes Center)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Center for Diabetes Technology', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Boris P. Kovatchev, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia Center for Diabetes Technology'}, {'name': 'Stacey M. Anderson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Virginia Center for Diabetes Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "NIH's Data Sharing Policy on sharing research resources for research purposes to the scientific community will be followed. Data will be stored in a Data Archive Database includes CGM-insulin delivery time series, meal content, boluses, \\& exercise will be deidentified \\& retrievable only by subject ID number. Individual patterns of demographic \\& insulin treatment parameters leave open a remote possibility of deductive disclosure of subjects with unusual characteristics. Thus, data will be made available only under a Data-Sharing Agreement that includes: (1) a commitment to using the data only for research purposes \\& not to identify participants; (2) a commitment to securing the data using appropriate computer technology; \\& (3) a commitment to destroying or returning the data after analyses are completed."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'Jaeb Center for Health Research', 'class': 'OTHER'}, {'name': 'TypeZero Technologies', 'class': 'INDUSTRY'}, {'name': 'DexCom, Inc.', 'class': 'INDUSTRY'}, {'name': 'Roche Diagnostic Ltd.', 'class': 'INDUSTRY'}, {'name': 'Ascensia Diabetes Care', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}