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

Technology-supported, Meal-centric, Insulin Dosing for Optimized Post-prandial Glucose Control

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Other: Meal-Tagging App; Device: Fitness Tracker

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with T1D

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Combined Diabetes Management Data; 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.	Other: Meal-Tagging App; Meal tagging app to capture frequently eaten meals and test meals for 16 weeks.; Device: Fitness Tracker; Fitness tracker will be worn around the clock for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c)	Change from Baseline to Week 16 in HbA1c	Baseline to Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals	Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals	Baseline to Week 16

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Joslin Diabetes Center

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Actual): August 7, 2020
• Study Completion (Actual): August 7, 2020

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 17111; F3Z-MC-IORA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No