Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
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 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.
Interventions
DEVICEcontinuous glucose monitor based insulin bolus calculator
Participants will use the bolus calculator with meals to calculate their insulin bolus doses
Sponsors
Welldoc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single group open label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time in range | 30 days | time in range using the calculator app will be non-inferior to baseline time in range |
Countries
United States
Outcome results
None listed