A Study of Technology to Improve Glucose Control in Participants With Type 1 Diabetes
NCT ID: NCT03758430
Last Updated: 2020-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
28 participants
OBSERVATIONAL
2019-02-06
2020-08-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Glucose Control in Participants With Type 1 and Type 2 Diabetes
NCT04667182
A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes
NCT01769404
Assessment of Mealtime Bolus Insulin Behavior
NCT03368807
Assessment of a Decision Support Tool in Participants With Type 1 Diabetes
NCT04428645
A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)
NCT03367390
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Meal-Tagging App
Meal tagging app to capture frequently eaten meals and test meals for 16 weeks.
Fitness Tracker
Fitness tracker will be worn around the clock for 16 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Meal-Tagging App
Meal tagging app to capture frequently eaten meals and test meals for 16 weeks.
Fitness Tracker
Fitness tracker will be worn around the clock for 16 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Joslin Diabetes Center
OTHER
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Joslin Diabetes Center
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
F3Z-MC-IORA
Identifier Type: OTHER
Identifier Source: secondary_id
17111
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.