NCT05229445

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

July 5, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2022

Completed
Last Updated

October 13, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

January 27, 2022

Last Update Submit

October 10, 2022

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1

Keywords

continuous glucose monitorinsulin calculator

Outcome Measures

Primary Outcomes (1)

  • time in range

    time in range using the calculator app will be non-inferior to baseline time in range

    30 days

Study Arms (1)

CGM insulin bolus calculator arm

EXPERIMENTAL

All participants will receive the CGM insulin bolus calculator

Device: continuous glucose monitor based insulin bolus calculator

Interventions

continuous glucose monitor based insulin bolus calculatorDEVICE

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

CGM insulin bolus calculator arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnancy,
  • insulin pump use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Grazia Aleppo

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group open label
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 8, 2022

Study Start

July 5, 2022

Primary Completion

September 28, 2022

Study Completion

September 28, 2022

Last Updated

October 13, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)