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

Eli Lilly and Company28 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

Meal-Tagging AppOTHER

Meal tagging app to capture frequently eaten meals and test meals for 16 weeks.

Fitness TrackerDEVICE

Fitness tracker will be worn around the clock for 16 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Joslin Diabetes Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c)

Change from Baseline to Week 16 in HbA1c

Time frame: Baseline to Week 16

Secondary Outcomes

Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals

Time frame: Baseline to Week 16

Data from ClinicalTrials.gov

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