GO TEAM: Glucose Optimization Through Technology Assisted Management

April 7, 2026 updated by: Sarah MacLeish

GO TEAM INTERVENTION PROTOCOL: GLUCOSE OPTIMIZATION THROUGH TECHNOLOGY ASSISTED MANAGEMENT: Use of a Diabetes Dashboard and Community Health Worker to Decrease Disparities in Technology Use in Pediatric T1D

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard of Care
Participants in this arm follow standard of care procedures.
Active Comparator: 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.
Other: Glucosano
Glucosano is a remote patient monitoring diabetes dashboard with a patient facing Smartphone application
Behavioral: Community Health Worker diabetes technology coach
Community Health Workers will work with participants as a diabetes technology coach during scheduled and as needed visits

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in percentage of participants who start on automated insulin delivery (AID) as measured by medical records review
Time Frame: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
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
Time Frame: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in patient endorsement of intervention as measured by the Acceptability of Intervention Measure (AIM)
Time Frame: 3 months and 12 months
4 item measure of acceptability using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree
3 months and 12 months
Change in patient endorsement of intervention as measured by Feasibility of Intervention Measure (FIM)
Time Frame: 3 months and 12 months
4 item measure of feasibility using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree
3 months and 12 months
Change in patient endorsement of intervention as measured by Intervention Appropriateness Measure (IAM)
Time Frame: 3 months and 12 months
4 item measure of appropriateness using 5 point Likert scale, where 1 is completely disagree and 5 is completely agree
3 months and 12 months
Number of times patient reached out to team as measured by medical record review
Time Frame: Up to 12 months
Up to 12 months
Number of automatically generated alerts as measured by dashboard/app review
Time Frame: Up to 12 months
Up to 12 months
Number of times a physician or diabetes nurse interacted with patient as measured by dashboard review
Time Frame: Up to 12 months
Up to 12 months
Number of alerts as measured by dashboard review
Time Frame: Up to 12 months
Up to 12 months
Number of phone calls initiated by patients as measured by dashboard review
Time Frame: Up to 12 months
Up to 12 months
Number of downloads of the app
Time Frame: Up to 12 months
Up to 12 months
Number of days of patient/family use interaction with the app as measured by dashboard review
Time Frame: Up to 12 months
Up to 12 months
Change in percentage of participants using continuous glucose monitor (CGM) with at least 80% wear time as measured by CGM data
Time Frame: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Change in percentage of CGM wear time as measured by CGM data
Time Frame: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Change in percentage of participants using an insulin pump as measured by chart review
Time Frame: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Change in time in range as measured by continuous glucose monitoring
Time Frame: 4 weeks, 6 months, 12 months
Time in range is time glucose is between 70-180 mg/dL
4 weeks, 6 months, 12 months
Change in time glucose is <70 mg/dL as measured by continuous glucose monitoring
Time Frame: 4 weeks, 6 months, 12 months
4 weeks, 6 months, 12 months
Change in time glucose >250 mg/dL as measured by continuous glucose monitoring
Time Frame: 4 weeks, 6 months, 12 months
4 weeks, 6 months, 12 months
Psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents
Time Frame: Baseline
25-item questionnaire using a 3-point Likert scale, with one being not true and 3 being certainly true
Baseline
Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale
Time Frame: 4 weeks, 12 months
19-item questionnaire using 3-point Likert scale, where 1 is almost never and 3 is almost always
4 weeks, 12 months
Change in child/adolescent quality of life, as measured by PedsQL Type 1 diabetes module by parent-proxy
Time Frame: 4 weeks, 12 months
28-item questionnaire using 5-point Likert scale, where 0 is almost never a problem and 4 is almost always a problem
4 weeks, 12 months
Change in parental burden related to diabetes, as measured by Problem Areas in Pediatric Diabetes - Parent Revised Version
Time Frame: 4 weeks, 12 months
18-item questionnaire using 5-point Likert scale, where 0 is agree and 4 is disagree
4 weeks, 12 months
Change in medical distrust, as measured by the Group Based Medical Distrust Scale
Time Frame: Baseline, 12 months
12-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Baseline, 12 months
Change personal frequency of discrimination in healthcare, as measured by the Racism in Healthcare Index
Time Frame: Baseline, 12 months
7-item questionnaire regarding frequency of discrimination in healthcare ranging from never to 4 times or more in a lifetime
Baseline, 12 months
Change in perceptions of racism in healthcare, as measured by the Racism in Healthcare Index
Time Frame: Baseline, 12 months
4-item questionnaire using 5 point Likert scale where 1 is strongly disagree and 5 is strongly agree
Baseline, 12 months
Change in diabetes specific attitudes towards technology as measured by the Diabetes Specific Technology Attitudes Scale
Time Frame: Baseline, 12 months
5-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Baseline, 12 months
Change in barriers to technology as measured by Barriers to Technology Checklist
Time Frame: Baseline, 12 months
19-item yes/no questionnaire
Baseline, 12 months
CGM satisfaction as measured by the CGM satisfaction scale
Time Frame: 12 months
37-item questionnaire using 5-point Likert scale, where 1 is strongly disagree and 5 is strongly agree
12 months
Change in diabetes management self-efficacy as measured by the Self-Efficacy for Diabetes Self-Management scale short version
Time Frame: 4 weeks, 12 months
10-item questionnaire using 6-point Likert scale, where 1 is "very sure I can't" and 6 is "very sure I can"
4 weeks, 12 months
Benefits and Burdens of CGM as measured by Benefits and Burdens of CGM scale
Time Frame: 12 months
16-item questionnaire using 5-point Likert scale, where 1 is strongly disagree and 5 is strongly agree
12 months
Episodes of Diabetic Ketoacidosis as measured by chart review
Time Frame: up to 12 months
DKA defined as presence of all of the following: 1) blood glucose greater than 250 mg/dL, 2) pH less than 7.3 OR bicarbonate less 15 mEq/L, 3)Moderate or large ketones in urine OR blood ketone >3 mmol/L, 4) Requiring treatment within a health care facility.
up to 12 months
Episodes of severe hypoglycemia as measured by chart review
Time Frame: up to 12 months
Unconscious or having a seizure due to hypoglycemia
up to 12 months
Change in capillary HbA1c
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
Baseline, 3 months, 6 months, 9 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sarah MacLeish

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
KeborMed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Study20230860
  • 1R01DK134953 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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