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OpenTrials
Completed

NCT Number: NCT03758430

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal-Tagging App

Other

Meal tagging app to capture frequently eaten meals and test meals for 16 weeks.

Fitness Tracker

Device

Fitness tracker will be worn around the clock for 16 weeks.

Primary outcomes

  1. Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c)

    Time frame: Baseline to Week 16

    Change from Baseline to Week 16 in HbA1c

Secondary outcomes

  1. Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals

    Time frame: Baseline to Week 16

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Joslin Diabetes Center

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2018
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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