A Continuous Glucose Monitor Based Insulin Bolus Calculator | NCT05229445

Studies
A Continuous Glucose Monitor Based Insulin Bolus Calculator

NCT05229445

Sponsor

Welldoc

Status

Completed

Last Update Posted

Oct 13, 2022Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1

Interventions

continuous glucose monitor based insulin bolus calculator

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 5, 2022Actual

Primary Completion Date

Sep 28, 2022Actual

Completion Date

Sep 28, 2022Actual

First Submitted Date

Jan 27, 2022

First Submission Date that Met QC Criteria

Jan 27, 2022

First Posted Date

Feb 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2022

Last Update Posted Date

Oct 13, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CGM insulin bolus calculator arm	Experimental	All participants will receive the CGM insulin bolus calculator	Device: continuous glucose monitor based insulin bolus calculator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
continuous glucose monitor based insulin bolus calculator	Device	Participants will use the bolus calculator with meals to calculate their insulin bolus doses	CGM insulin bolus calculator arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time in range	time in range using the calculator app will be non-inferior to baseline time in range	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

pregnancy,
insulin pump use

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Grazia Aleppo	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University		Chicago	Illinois	60611	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided