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

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: Meal-Tagging App; Device: Fitness Tracker

• Registration Number: NCT03758430
• Lead Sponsor: Eli Lilly and Company

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-29
• Study Start: 2019-02-06
• Status Verified: 2020-08
• Primary Completion: 2020-08-07
• Study Completion: 2020-08-07
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Combined Diabetes Management Data	Meal-Tagging App	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.
Combined Diabetes Management Data	Fitness Tracker	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States