Safety of a Real-time Continuous Glucose Monitor-based Insulin Bolus Calculator: The "CGM-IBC" Study B
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- The percentage of time a participant's glucose value is between 70 and 180 mg/dL will not be inferior to baseline.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 1 or type 2 diabetes using the Dexcom G6 continuous glucose monitor
Exclusion Criteria
- •Pregnancy
Arms & Interventions
CGM insulin bolus calculator arm
Participants will use the CGM insulin bolus calculator arm
Intervention: BlueStar 10 (Device)
Outcomes
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
Secondary Outcomes
No secondary outcomes reported