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Active, Not Recruiting

NCT Number: NCT06074458

GO TEAM: Glucose Optimization Through Technology Assisted Management

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucosano

Other

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

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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. 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

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

    Time frame: Up to 12 months

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

    Time frame: Up to 12 months

  6. Number of times a physician or diabetes nurse interacted with patient as measured by dashboard review

    Time frame: Up to 12 months

  7. Number of alerts as measured by dashboard review

    Time frame: Up to 12 months

  8. Number of phone calls initiated by patients as measured by dashboard review

    Time frame: Up to 12 months

  9. Number of downloads of the app

    Time frame: Up to 12 months

  10. Number of days of patient/family use interaction with the app as measured by dashboard review

    Time frame: Up to 12 months

  11. 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

  12. 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

  13. 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

  14. Change in capillary HbA1c

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months

  15. 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

  16. Change in time glucose is <70 mg/dL as measured by continuous glucose monitoring

    Time frame: 4 weeks, 6 months, 12 months

  17. Change in time glucose >250 mg/dL as measured by continuous glucose monitoring

    Time frame: 4 weeks, 6 months, 12 months

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. Change in barriers to technology as measured by Barriers to Technology Checklist

    Time frame: Baseline, 12 months

    19-item yes/no questionnaire

  27. 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

  28. 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"

  29. 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

  30. 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.

  31. Episodes of severe hypoglycemia as measured by chart review

    Time frame: up to 12 months

    Unconscious or having a seizure due to hypoglycemia

Sponsors and collaborators

Lead sponsor

Sarah MacLeish

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 10, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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