NCT05343065

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

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable diabetes-mellitus

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

April 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 5, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

March 17, 2023

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

April 16, 2022

Last Update Submit

March 15, 2023

Conditions

Diabetes Mellitus

Keywords

continuous glucose monitor, insulin calculator

Outcome Measures

Primary Outcomes (1)

  • The percentage of time a participant's glucose value is between 70 and 180 mg/dL will not be inferior to baseline.

    30 days

Study Arms (1)

CGM insulin bolus calculator arm

EXPERIMENTAL

Participants will use the CGM insulin bolus calculator arm

Device: BlueStar 10

Interventions

BlueStar 10DEVICE

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

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 or type 2 diabetes using the Dexcom G6 continuous glucose monitor

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedStar Health Research Institute

Baltimore, Maryland, 21239, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jean Park

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2022

First Posted

April 25, 2022

Study Start

July 5, 2022

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

March 17, 2023

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)