Type 1 Diabetes, Type 2 Diabetes
Conditions
Keywords
T1D, T2D
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 (T1D) and type 2 diabetes (T2D). No study drug will be given. The study will last about 18 weeks.
Interventions
OTHERMeal-Tagging App and Web-based Portal:
Meal tagging app to capture frequently eaten meals and test meals for 18 weeks.
DEVICEFitness Tracker
Fitness tracker will be worn around the clock for 18 weeks.
Sponsors
Eli Lilly and Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Area Under the Curve (AUC) of CGM | Baseline, Week 17 | Change from Baseline in AUC of CGM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative data from study investigators and participants | Baseline through Week 17 | Qualitative data describing experience from study investigators and participants |
| Percent Time-in-Range (TIR) | Baseline through Week 17 | Percent Time-in-Range defined as glucose \>70 and ≤180 milligrams per deciliter \[mg/dL\]) |
| Postprandial TIR | Baseline through Week 17 | Postprandial TIR is defined as TIR glucose: glucose \>=70 and ≤180 mg/dL |
| Time Above Range (TAR) | Baseline through Week 17 | TAR is defined as glucose \> 180 mg/dL |
| Time Below Range (TBR) <70 mg/dL | Baseline through Week 17 | TBR is defined as glucose \< 70 mg/dL |
Countries
United States
Outcome results
None listed