NCT05343065

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Welldoc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	BlueStar 10	An app that coaches individuals with diabetes and supports insulin-dosing based on continuous glucose monitor data

Timeline

• Start date: 2022-07-05
• Primary completion: 2022-12-20
• Completion: 2022-12-20
• First posted: 2022-04-25
• Last updated: 2023-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study