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

Lilly

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Fitness Tracker; Other: Meal-Tagging App

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03758430

17111

F3Z-MC-IORA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

28 participants in 1 patient group

Combined Diabetes Management Data

Description:

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.

Treatment:

Device: Fitness Tracker

Other: Meal-Tagging App