A Continuous Glucose Monitor Based Insulin Bolus Calculator

NCT ID: NCT05229445

Last Updated: 2022-10-13

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

2022-09-28

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 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.

Conditions

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Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group open label
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CGM insulin bolus calculator arm

All participants will receive the CGM insulin bolus calculator

Group Type EXPERIMENTAL

continuous glucose monitor based insulin bolus calculator

Intervention Type DEVICE

Participants will use the bolus calculator with meals to calculate their insulin bolus doses

Interventions

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continuous glucose monitor based insulin bolus calculator

Participants will use the bolus calculator with meals to calculate their insulin bolus doses

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* type 1 diabetes
* type 2 diabetes
* using Dexcom G6 CGM system
* injecting bolus insulin

Exclusion Criteria

* pregnancy,
* insulin pump use
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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Grazia Aleppo

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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WD001

Identifier Type: -

Identifier Source: org_study_id

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