A Study of Technology to Improve Glucose Control in Participants With Type 1 Diabetes
Study Details
Study Description
Brief Summary
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 diabetes (T1D). No study drug will be given. The study will last about 18 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Combined Diabetes Management Data Participants with type 1 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 continuous glucose monitor and insulin pump. Combined data will be used for diabetes management. |
Other: Meal-Tagging App
Meal tagging app to capture frequently eaten meals and test meals for 16 weeks.
Device: Fitness Tracker
Fitness tracker will be worn around the clock for 16 weeks.
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c) [Baseline to Week 16]
Change from Baseline to Week 16 in HbA1c
Secondary Outcome Measures
- Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals [Baseline to Week 16]
Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals
Eligibility Criteria
Criteria
Inclusion Criteria:
-
T1D by clinical diagnosis for > 3 years
-
Insulin pump use > 3 months: must use one of the following pump types: Animas Ping and Vibe, Insulet Omnipod, Medtronic 523/723 and 530G, Tandem t:slim and t:flex
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Continuous Glucose Monitor (CGM) > 3 months and current use of Dexcom G5 at least 6 out of 7 days per week
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HbA1c 7.0-9.5%
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Must have iPhone (meal-tagging app has been built on iOS)
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Personal computer for uploading of pump and CGM devices
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Willingness to follow study protocol including tagging food data
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Comfort speaking, reading, and writing English
Exclusion Criteria:
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Individuals currently using a hybrid closed-loop system (e.g., Medtronic 670G)
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Individuals planning to follow a specific diet plan for weight loss
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Inability to consume "common meals"
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Gastroparesis;
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Eating disorder
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Evidence of missed insulin meal-time insulin boluses on pump download
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Use of medications that can affect blood glucose levels (such as SGLT inhibitors, steroid, beta agonists)
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Use of medications that affect gastric emptying (such as GLP agonists, pramlinitide)
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Alcohol abuse
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Pre-conception, pregnancy, or lactation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Joslin Diabetes Center | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Eli Lilly and Company
- Joslin Diabetes Center
Investigators
- Study Director: 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17111
- F3Z-MC-IORA