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

Welldoc

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: BlueStar 10

Study type: Interventional

Funder types: Industry

Identifiers

NCT05343065

WD002

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or type 2 diabetes using the Dexcom G6 continuous glucose monitor

Exclusion criteria

• Pregnancy

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

CGM insulin bolus calculator arm

Experimental group

Description:

Participants will use the CGM insulin bolus calculator arm

Treatment:

Device: BlueStar 10