A Study of Glucose Control in Participants With Type 1 and Type 2 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 (T1D) and type 2 diabetes (T2D). No study drug will be given. The study will last about 18 weeks.

Official Title
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Meal-centric Insulin Dosing for Optimized Post-Prandial Glucose Control in People Using Multiple Daily Injections

Conditions
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Type 1 Diabetes, Type 2 Diabetes

Intervention / Treatment
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* Other: Meal-Tagging App and Web-based Portal:
* Device: Fitness Tracker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals with type 1 or type 2 diabetes for >3 years by clinical diagnosis who use basal insulin, in addition to at least one injection of meal time insulin per day Insulin pen use for at least 3 months Current use of or willingness to use Dexcom G6 at least 6 out of 7 days per week A1c 6.5-9.5% Exclusion Criteria: Currently using any form of insulin pump, including hybrid closed-loop system (e.g., Medtronic 670G) Individuals requiring single insulin boluses of >40 units Individuals planning to follow a specific diet plan for weight loss Inability to consume regular, consistent meals Individuals who have had severe hypoglycemia with seizure or coma within the past 6 months Individuals who have been hospitalized for diabetic ketoacidosis (DKA) within the past 6 months

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 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 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. | Other: Meal-Tagging App and Web-based Portal:<br>* Meal tagging app to capture frequently eaten meals and test meals for 18 weeks.<br>Device: Fitness Tracker<br>* Fitness tracker will be worn around the clock for 18 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T1D, T2D