Safety of a Real-time Continuous Glucose Monitor-based Insulin Bolus Calculator: The "CGM-IBC" Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- time in range
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •type 1 diabetes
- •type 2 diabetes
- •using Dexcom G6 CGM system
- •injecting bolus insulin
Exclusion Criteria
- •pregnancy,
- •insulin pump use
Outcomes
Primary Outcomes
time in range
Time Frame: 30 days
time in range using the calculator app will be non-inferior to baseline time in range
Secondary Outcomes
No secondary outcomes reported