GO TEAM: Glucose Optimization Through Technology Assisted Management

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: Active, not recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Glucosano; Behavioral: Community Health Worker diabetes technology coach

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient endorsement of intervention as measured by the Acceptability of Intervention Measure (AIM)	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)	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)	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		Up to 12 months
Number of automatically generated alerts as measured by dashboard/app review		Up to 12 months
Number of times a physician or diabetes nurse interacted with patient as measured by dashboard review		Up to 12 months
Number of alerts as measured by dashboard review		Up to 12 months
Number of phone calls initiated by patients as measured by dashboard review		Up to 12 months
Number of downloads of the app		Up to 12 months
Number of days of patient/family use interaction with the app as measured by dashboard review		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		Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Change in percentage of CGM wear time as measured by CGM data		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		Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Change in time in range as measured by continuous glucose monitoring	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		4 weeks, 6 months, 12 months
Change in time glucose >250 mg/dL as measured by continuous glucose monitoring		4 weeks, 6 months, 12 months
Psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents	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	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	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	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	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	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	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	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	19-item yes/no questionnaire	Baseline, 12 months
CGM satisfaction as measured by the CGM satisfaction scale	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	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	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	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	Unconscious or having a seizure due to hypoglycemia	up to 12 months
Change in capillary HbA1c		Baseline, 3 months, 6 months, 9 months, 12 months

Collaborators and Investigators

• Sponsor: Sarah MacLeish
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); KeborMed

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Estimated): January 27, 2027
• Study Completion (Estimated): January 27, 2027

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric; Disparities; Diabetes Technology
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID 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