Status:
COMPLETED
A Study of Technology to Improve Glucose Control in Participants With Type 1 Diabetes
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Joslin Diabetes Center
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-70 years
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. Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 6 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 7 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03758430
Start Date
February 6 2019
End Date
August 7 2020
Last Update
August 21 2020
Active Locations (1)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215