NCT05229445

A Continuous Glucose Monitor Based Insulin Bolus Calculator

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

• 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 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.

Conditions

• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	continuous glucose monitor based insulin bolus calculator	Participants will use the bolus calculator with meals to calculate their insulin bolus doses

Timeline

• Start date: 2022-07-05
• Primary completion: 2022-09-28
• Completion: 2022-09-28
• First posted: 2022-02-08
• Last updated: 2022-10-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study