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NCT05229445 Clinical Trial

A Continuous Glucose Monitor Based Insulin Bolus Calculator

Diabetes Mellitus, Type 2 Clinical Trial

— CGM-IBC  

Official title:
Safety of a Real-time Continuous Glucose Monitor-based Insulin Bolus Calculator: The "CGM-IBC" Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05229445
Other study ID # WD001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 5, 2022
Est. completion date September 28, 2022

Study information
Verified date January 2022
Source Welldoc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date September 28, 2022
Est. primary completion date September 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - type 1 diabetes - type 2 diabetes - using Dexcom G6 CGM system - injecting bolus insulin Exclusion Criteria: - pregnancy, - insulin pump use

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• continuous glucose monitor based insulin bolus calculator
Participants will use the bolus calculator with meals to calculate their insulin bolus doses

Locations
Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Welldoc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary time in range time in range using the calculator app will be non-inferior to baseline time in range 30 days
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