Back to resultsA Continuous Glucose Monitor Based Insulin Bolus Calculator (CGM-IBC)
Primary Purpose
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
continuous glucose monitor based insulin bolus calculator
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring continuous glucose monitor, insulin calculator
Eligibility Criteria
Inclusion Criteria:
- type 1 diabetes
- type 2 diabetes
- using Dexcom G6 CGM system
- injecting bolus insulin
Exclusion Criteria:
- pregnancy,
- insulin pump use
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CGM insulin bolus calculator arm
Arm Description
All participants will receive the CGM insulin bolus calculator
Outcomes
Primary Outcome Measures
time in range
time in range using the calculator app will be non-inferior to baseline time in range
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05229445
Brief Title
A Continuous Glucose Monitor Based Insulin Bolus Calculator
Acronym
CGM-IBC
Official Title
Safety of a Real-time Continuous Glucose Monitor-based Insulin Bolus Calculator: The "CGM-IBC" Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
September 28, 2022 (Actual)
Study Completion Date
September 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Welldoc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Keywords
continuous glucose monitor, insulin calculator
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group open label
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CGM insulin bolus calculator arm
Arm Type
Experimental
Arm Description
All participants will receive the CGM insulin bolus calculator
Intervention Type
Device
Intervention Name(s)
continuous glucose monitor based insulin bolus calculator
Intervention Description
Participants will use the bolus calculator with meals to calculate their insulin bolus doses
Primary Outcome Measure Information:
Title
time in range
Description
time in range using the calculator app will be non-inferior to baseline time in range
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 1 diabetes
type 2 diabetes
using Dexcom G6 CGM system
injecting bolus insulin
Exclusion Criteria:
pregnancy,
insulin pump use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grazia Aleppo
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Continuous Glucose Monitor Based Insulin Bolus Calculator
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