A Continuous Glucose Monitor Based Insulin Bolus Calculator (CGM-IBC) Study B

NCT ID: NCT05343065

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-05

Study Completion Date

2022-12-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CGM insulin bolus calculator arm

Participants will use the CGM insulin bolus calculator arm

Group Type EXPERIMENTAL

BlueStar 10

Intervention Type DEVICE

An app that coaches individuals with diabetes and supports insulin-dosing based on continuous glucose monitor data

Interventions

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BlueStar 10

An app that coaches individuals with diabetes and supports insulin-dosing based on continuous glucose monitor data

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Type 1 or type 2 diabetes using the Dexcom G6 continuous glucose monitor

Exclusion Criteria

* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Welldoc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Park

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

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MedStar Health Research Institute

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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WD002

Identifier Type: -

Identifier Source: org_study_id

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