A Continuous Glucose Monitor Based Insulin Bolus Calculator (CGM-IBC) Study B

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

Completed

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Health Research Institute

Baltimore, Maryland, 21239, 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 Welldoc (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 or type 2 diabetes using the Dexcom G6 continuous glucose monitor

Exclusion criteria

Pregnancy

Treatment and study plan

BlueStar 10

Device

An app that coaches individuals with diabetes and supports insulin-dosing based on continuous glucose monitor data

Primary outcomes

The percentage of time a participant's glucose value is between 70 and 180 mg/dL will not be inferior to baseline.

Time frame: 30 days

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 B

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Apr 25, 2022
Registry last updated: Mar 17, 2023

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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Completed