A Study of Technology to Improve Glucose Control in Participants With Type 1 Diabetes

Study Overview
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Brief Summary
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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 diabetes (T1D). No study drug will be given. The study will last about 18 weeks.

Official Title
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Technology-supported, Meal-centric, Insulin Dosing for Optimized Post-prandial Glucose Control

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Other: Meal-Tagging App
* Device: Fitness Tracker


Participation Criteria
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Eligibility Criteria
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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 Continuous Glucose Monitor (CGM) > 3 months and current use of Dexcom G5 at least 6 out of 7 days per week HbA1c 7.0-9.5% Must have iPhone (meal-tagging app has been built on iOS) Personal computer for uploading of pump and CGM devices Willingness to follow study protocol including tagging food data Comfort speaking, reading, and writing English Exclusion Criteria: Individuals currently using a hybrid closed-loop system (e.g., Medtronic 670G) Individuals planning to follow a specific diet plan for weight loss Inability to consume common meals Gastroparesis; Eating disorder Evidence of missed insulin meal-time insulin boluses on pump download Use of medications that can affect blood glucose levels (such as SGLT inhibitors, steroid, beta agonists) Use of medications that affect gastric emptying (such as GLP agonists, pramlinitide) Alcohol abuse Pre-conception, pregnancy, or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Combined Diabetes Management Data<br>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<br>* Meal tagging app to capture frequently eaten meals and test meals for 16 weeks.<br>Device: Fitness Tracker<br>* Fitness tracker will be worn around the clock for 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c) | Change from Baseline to Week 16 in HbA1c | Baseline to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals | Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals | Baseline to Week 16 |