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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03758430
• Other study ID #: 17111
• Secondary ID: F3Z-MC-IORA
• Status: Completed
• Start date: February 6, 2019
• Est. completion date: August 7, 2020

Study information

• Verified date: August 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 7, 2020
• Est. primary completion date: August 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c)	Change from Baseline to Week 16 in HbA1c	Baseline to Week 16
Secondary	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