GO TEAM: Glucose Optimization Through Technology Assisted Management

NCT ID: NCT06074458

Last Updated: 2025-07-28

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2026-11-02

Brief Summary

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Black/African American children and young adults with type 1 diabetes are less likely to use diabetes technologies, such as continuous glucose monitors, insulin pumps, and automated insulin delivery systems, compared to White children and young adults. The investigators are working to find ways to make sure that all patients with type 1 diabetes are equally able to use these technologies. The purpose of this study is to find out if a new computer program for the diabetes team, along with a smartphone app (called Glucosano) for patients/parents, as well as a community health worker, are accepted and used by Black/African American patients and parents living with type 1 diabetes, and if this can help decrease racial disparities in the use of diabetes technologies.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard of Care

Participants in this arm follow standard of care procedures.

Group Type NO_INTERVENTION

No interventions assigned to this group

Diabetes Dashboard and Community Health Worker

Participants diabetes technology devices will be linked to a remote patient monitoring dashboard and will have access to a Smartphone application, as well as scheduled and as needed visits with a community health worker.

Group Type ACTIVE_COMPARATOR

Glucosano

Intervention Type OTHER

Glucosano is a remote patient monitoring diabetes dashboard with a patient facing Smartphone application

Community Health Worker diabetes technology coach

Intervention Type BEHAVIORAL

Community Health Workers will work with participants as a diabetes technology coach during scheduled and as needed visits

Interventions

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Glucosano

Glucosano is a remote patient monitoring diabetes dashboard with a patient facing Smartphone application

Intervention Type OTHER

Community Health Worker diabetes technology coach

Community Health Workers will work with participants as a diabetes technology coach during scheduled and as needed visits

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Self-reported as Non-Hispanic Black
* Clinical diagnosis of T1D requiring treatment with insulin at the time of consent
* Not currently (within the past 3 months) using an automated insulin delivery system \\
* Willingness to wear a continuous glucose monitor for 10 days at 3 different time points, and willingness to consider use of a personal continuous glucose monitor

Exclusion Criteria

* Clinical diagnosis of Type 2 or monogenic diabetes
* Completed high school
* Non-English speaking guardians
* Automated insulin delivery system use within the past 3 months
* Custody of children and family services
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

KeborMed

UNKNOWN

Sponsor Role collaborator

Sarah MacLeish

OTHER

Sponsor Role lead

Responsible Party

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Sarah MacLeish

Associate Professor of Pediatrics

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah MacLeish, DO

Role: CONTACT

216-844-3661

Julie Hutter, RN

Role: CONTACT

216-844-3661

Facility Contacts

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Julie Hutter, RN

Role: primary

216-844-3661

Terri Casey, RN, CDCES

Role: backup

216-844-3627

Other Identifiers

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1R01DK134953

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Study20230860

Identifier Type: -

Identifier Source: org_study_id

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