Skip to main content
OpenTrials
Completed

NCT Number: NCT05229445

A Continuous Glucose Monitor Based Insulin Bolus Calculator

This study examines the safety of an app-based insulin bolus calculator that utilizes glucose values from a continuous glucose monitor

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

Individuals with type 1 diabetes and those with type 2 diabetes who are prescribed bolus insulin must decide on an insulin dose for any given meal. This dose is often based on what they are eating and their glucose value. Insulin bolus calculators may be helpful in recommending an insulin dose. This study examines the safety of an app-based insulin calculator manufactured by Welloc (Columbia, MD). This app uses the glucose value and trend arrow, in certain circumstances, to recommend a bolus insulin dose. This study is a single arm trial where continuous glucose monitoring metrics such as time in range will be measured before and after the study participants are given the app.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • type 1 diabetes
  • type 2 diabetes
  • using Dexcom G6 CGM system
  • injecting bolus insulin

Exclusion criteria

  • pregnancy,
  • insulin pump use

Treatment and study plan

continuous glucose monitor based insulin bolus calculator

Device

Participants will use the bolus calculator with meals to calculate their insulin bolus doses

Primary outcomes

  1. time in range

    Time frame: 30 days

    time in range using the calculator app will be non-inferior to baseline time in range

Sponsors and collaborators

Lead sponsor

Welldoc

Industry

Registry information

Official study title

Safety of a Real-time Continuous Glucose Monitor-based Insulin Bolus Calculator: The "CGM-IBC" Study

Acronym: CGM-IBC

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2022
Registry last updated
Oct 13, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.