Diabetes Mellitus
Conditions
Keywords
continuous glucose monitor, insulin calculator
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.
Interventions
DEVICEBlueStar 10
An app that coaches individuals with diabetes and supports insulin-dosing based on continuous glucose monitor data
Sponsors
Welldoc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 or type 2 diabetes using the Dexcom G6 continuous glucose monitor
Exclusion criteria
* Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of time a participant's glucose value is between 70 and 180 mg/dL will not be inferior to baseline. | 30 days |
Countries
United States
Outcome results
None listed