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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-MC-IORN | Other Identifier | Eli Lilly and Company |
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Study was withdrawn prior to enrolment due to business decision.
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The main purpose of this study is to determine whether combining meal, glucose and insulin data in a web-based system will improve management of type 1 (T1D) and type 2 diabetes (T2D). No study drug will be given. The study will last about 18 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Diabetes Management Data | Participants with type 1 and type 2 diabetes will use a meal tagging application (app) and fitness tracker. They will upload these data to a web portal where they will be matched with data from their insulin pen and continuous glucose monitor (CGM). Combined data will be used as a complement to standard of care for diabetes management. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meal-Tagging App and Web-based Portal: | Other | Meal tagging app to capture frequently eaten meals and test meals for 18 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Area Under the Curve (AUC) of CGM | Change from Baseline in AUC of CGM | Baseline, Week 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative data from study investigators and participants | Qualitative data describing experience from study investigators and participants | Baseline through Week 17 |
| Percent Time-in-Range (TIR) |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with T1D and T2D
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States | ||
| University of North Carolina, Chapel Hill |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000072936 | Fitness Trackers |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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| Fitness Tracker | Device | Fitness tracker will be worn around the clock for 18 weeks. |
|
Percent Time-in-Range defined as glucose >70 and ≤180 milligrams per deciliter [mg/dL])
| Baseline through Week 17 |
| Postprandial TIR | Postprandial TIR is defined as TIR glucose: glucose >=70 and ≤180 mg/dL | Baseline through Week 17 |
| Time Above Range (TAR) | TAR is defined as glucose > 180 mg/dL | Baseline through Week 17 |
| Time Below Range (TBR) <70 mg/dL | TBR is defined as glucose < 70 mg/dL | Baseline through Week 17 |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |