Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-04 @ 2:05 PM
Study NCT ID:
NCT03290768
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2017-09-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072936', 'term': 'Fitness Trackers'}], 'ancestors': [{'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000076251', 'term': 'Wearable Electronic Devices'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'JaredJones@savvysherpa.com', 'phone': '763-549-3540', 'title': 'Jared Jones', 'phoneExt': '8116', 'organization': 'Savvysherpa, LLC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '10 weeks per participant', 'eventGroups': [{'id': 'EG000', 'title': 'Diabetes Management Educational Program', 'description': 'Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.\n\nContinuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.\n\nActivity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.\n\nCoaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.', 'otherNumAtRisk': 358, 'deathsNumAtRisk': 358, 'otherNumAffected': 10, 'seriousNumAtRisk': 358, 'deathsNumAffected': 2, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Bleeding at Insertion Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising at Insertion Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Detached/Broken Sensor Wire', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness/Rash at insertion site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death from Cardiopulmonary Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death from artherosclerotic and hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Program Enrollment Rate (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5896', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetes Management Educational Program', 'description': 'Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.\n\nContinuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.\n\nActivity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.\n\nCoaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 9 months', 'description': '(Number of patients who were shipped devices) / (Number of patients invited to enroll) \\* 100', 'unitOfMeasure': 'percentage of invitees', 'reportingStatus': 'POSTED', 'populationDescription': 'Note that the number analyzed is greater than the number of participants (358) because participants are a subset of those who were invited to participate.'}, {'type': 'PRIMARY', 'title': 'Program Completion Rate (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetes Management Educational Program', 'description': 'Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.\n\nContinuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.\n\nActivity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.\n\nCoaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 9 months', 'description': '(Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) \\* 100', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Unit of measure, below, should read, "percentage of participants completing 10 weeks of CGM," but there is not enough space.'}, {'type': 'SECONDARY', 'title': 'Weekly Average of Estimated Glucose Values (EGV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetes Management Educational Program', 'description': 'Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.\n\nContinuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.\n\nActivity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.\n\nCoaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '153.9', 'spread': '59.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '152.7', 'spread': '57.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '152.3', 'spread': '57.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '152.9', 'spread': '57.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '151.5', 'spread': '54.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '151.1', 'spread': '52.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '149.9', 'spread': '52.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '149.4', 'spread': '54.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '151.0', 'spread': '55.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '149.6', 'spread': '54.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 10 weeks', 'description': '(Sum of EGV for a given week) / (Total number of EGV for a given week)', 'unitOfMeasure': 'milligrams/deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '358 Participants started the study, but participants dropped out as time passed. By week 10, there were only 193 participants remaining who were providing EGV.'}, {'type': 'SECONDARY', 'title': 'Change in Medication Dosage (mg/Day; U/Day)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetes Management Educational Program', 'description': 'Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.\n\nContinuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.\n\nActivity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.\n\nCoaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.'}], 'timeFrame': 'up to 9 months', 'description': '(dosage of Rx on Day 180) - (dosage of Rx on Day 0)', 'reportingStatus': 'POSTED', 'populationDescription': 'After starting the study, administrator realized that it would not be able to obtain medication data from participants. There is no data to report for this measure.'}, {'type': 'SECONDARY', 'title': 'Average Age of Participants Who Start Trial (Yrs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetes Management Educational Program', 'description': 'Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.\n\nContinuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.\n\nActivity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.\n\nCoaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'spread': '7.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 9 months', 'description': '(Sum of ages of all enrollees) / (Total number of enrollees)', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the 358 participants who started the study lacked age data.'}, {'type': 'SECONDARY', 'title': 'Average Age of Participants Who Complete Trial (Yrs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetes Management Educational Program', 'description': 'Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.\n\nContinuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.\n\nActivity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.\n\nCoaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'spread': '6.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 9 months', 'description': '(Sum of age of patients who complete) / (Total number who complete)', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One of the 193 participants who completed 10 weeks of CGM use lacked age data.'}, {'type': 'SECONDARY', 'title': 'Texting With Coaches', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetes Management Educational Program', 'description': 'Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.\n\nContinuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.\n\nActivity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.\n\nCoaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.003', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 9 months', 'description': '(Sum of all text messages) / (Total number of participants\\*days)', 'unitOfMeasure': 'text messages per participant per day', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Coaching Participation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetes Management Educational Program', 'description': 'Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.\n\nContinuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.\n\nActivity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.\n\nCoaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 9 months', 'description': '(Sum of weekly coaching calls completed) / (Total number of participants\\*weeks)', 'unitOfMeasure': 'calls per participant per week', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diabetes Management Educational Program', 'description': 'Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.\n\nContinuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.\n\nActivity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.\n\nCoaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '358'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Diabetes Management Educational Program', 'description': 'Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.\n\nContinuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.\n\nActivity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.\n\nCoaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '71.4', 'spread': '7.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two participants lacked age data.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '184', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '171', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Three participants lacked gender data.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '358', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-19', 'size': 637591, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-23T18:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 358}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2017-09-19', 'resultsFirstSubmitDate': '2019-05-23', 'studyFirstSubmitQcDate': '2017-09-20', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-25', 'studyFirstPostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Program Enrollment Rate (%)', 'timeFrame': 'up to 9 months', 'description': '(Number of patients who were shipped devices) / (Number of patients invited to enroll) \\* 100'}, {'measure': 'Program Completion Rate (%)', 'timeFrame': 'up to 9 months', 'description': '(Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) \\* 100'}], 'secondaryOutcomes': [{'measure': 'Weekly Average of Estimated Glucose Values (EGV)', 'timeFrame': 'up to 10 weeks', 'description': '(Sum of EGV for a given week) / (Total number of EGV for a given week)'}, {'measure': 'Change in Medication Dosage (mg/Day; U/Day)', 'timeFrame': 'up to 9 months', 'description': '(dosage of Rx on Day 180) - (dosage of Rx on Day 0)'}, {'measure': 'Average Age of Participants Who Start Trial (Yrs)', 'timeFrame': 'up to 9 months', 'description': '(Sum of ages of all enrollees) / (Total number of enrollees)'}, {'measure': 'Average Age of Participants Who Complete Trial (Yrs)', 'timeFrame': 'up to 9 months', 'description': '(Sum of age of patients who complete) / (Total number who complete)'}, {'measure': 'Texting With Coaches', 'timeFrame': 'up to 9 months', 'description': '(Sum of all text messages) / (Total number of participants\\*days)'}, {'measure': 'Coaching Participation Rate', 'timeFrame': 'up to 9 months', 'description': '(Sum of weekly coaching calls completed) / (Total number of participants\\*weeks)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Type2 Diabetes']}, 'descriptionModule': {'briefSummary': "This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor (CGM) as part of an educational program designed to help them better manage their glucose levels. Subjects will also wear an activity tracker to monitor their activity and observe its effect on their glucose levels. The educational program will involve calls from coaches to check subjects' progress and answer questions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be diagnosed with type 2 diabetes\n* Be able to read and understand English\n* Have access to a telephone\n* Have a Medicare Advantage health plan through Senior Dimensions\n\nExclusion Criteria:\n\n* Pregnant\n* Blind\n* Deaf\n* Receiving chemotherapy or radiation to treat cancer (now or in past 6 months)\n* Misusing any drugs (including alcohol, painkillers, hallucinogens, or others)\n* Critically ill\n* Diagnosed with or experiencing:\n\n * Kidney disease stages 4 and 5\n * End stage renal disease\n * Severe liver disease\n * Dementia\n * Schizophrenia\n * Bipolar disorder\n * Autism\n * An intellectual or learning disability\n * Arrhythmias other than atrial fibrillation\n * Congestive heart failure\n* Has had a:\n\n * Myocardial infarction within the last 6 months\n * Stroke within the last 6 months\n * Stroke that resulted in significant disability (e.g., unable to write clearly or walk)'}, 'identificationModule': {'nctId': 'NCT03290768', 'acronym': 'CGM_IRB-3', 'briefTitle': 'Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Savvysherpa, Inc.'}, 'officialTitle': 'Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot (SMA Investigational Device)', 'orgStudyIdInfo': {'id': 'Pro00022589'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetes Management Educational Program', 'description': 'Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.', 'interventionNames': ['Device: Continuous Glucose Monitor (CGM)', 'Device: Activity Tracker', 'Behavioral: Coaching']}], 'interventions': [{'name': 'Continuous Glucose Monitor (CGM)', 'type': 'DEVICE', 'otherNames': ['Dexcom Investigational Use Only (IUO) Device'], 'description': 'Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.', 'armGroupLabels': ['Diabetes Management Educational Program']}, {'name': 'Activity Tracker', 'type': 'DEVICE', 'otherNames': ['Fitbit Charge 2'], 'description': 'Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.', 'armGroupLabels': ['Diabetes Management Educational Program']}, {'name': 'Coaching', 'type': 'BEHAVIORAL', 'description': 'Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.', 'armGroupLabels': ['Diabetes Management Educational Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Southwest Medical Associates', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Savvysherpa, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}