GO TEAM: Glucose Optimization Through Technology Assisted Management

NCT06074458 | Active Not Recruiting DMC

• 2 other identifiers: Study202308601R01DK134953
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

Pediatric; Diabetes Technology; Disparities

Outcome Measures

Primary Outcomes (2)

• Change in percentage of participants who start on automated insulin delivery (AID) as measured by medical records review

  Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months

• Change in percentage of participants who remain on AID as measured by medical record review

  Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months

Secondary Outcomes (31)

• Change in patient endorsement of intervention as measured by the Acceptability of Intervention Measure (AIM)

  3 months and 12 months

• Change in patient endorsement of intervention as measured by Feasibility of Intervention Measure (FIM)

  3 months and 12 months

• Change in patient endorsement of intervention as measured by Intervention Appropriateness Measure (IAM)

  3 months and 12 months

• Number of times patient reached out to team as measured by medical record review

  Up to 12 months

• Number of automatically generated alerts as measured by dashboard/app review

  Up to 12 months

Study Arms (2)

Standard of Care

NO INTERVENTION

Participants in this arm follow standard of care procedures.

Diabetes Dashboard and Community Health Worker

ACTIVE COMPARATOR

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.

Other: Glucosano; Behavioral: Community Health Worker diabetes technology coach

Interventions

Glucosano OTHER

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

Diabetes Dashboard and Community Health Worker

Community Health Worker diabetes technology coach BEHAVIORAL

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

Diabetes Dashboard and Community Health Worker

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sarah MacLeish: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• KeborMed: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: January 29, 2024
• Primary Completion (Estimated): January 27, 2027
• Study Completion (Estimated): January 27, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)