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NCT Number: NCT07154251

Utilizing Community Health Workers as Diabetes Technology Coaches for Children With Type 1 Diabetes Using Automated Insulin Delivery

This study uses community health workers (CHW) as diabetes technology coaches for African American children using automated insulin delivery systems but have an HbA1c of 8% or higher. Families will meet with the CHW monthly x 6 months with additional visits as needed. All participants and parents/guardians will fill out questionnaires at the beginning and end of the 6 month intervention in addition to an interview at 6 months. This will be followed by 6 months with no extra help from the CHW, but we will continue to follow CGM and pump download data.

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Key information

Conditions

Type 1 Diabetes (T1D) 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

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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 type 1 diabetes, requiring treatment with insulin at the time of consent
  • Currently using, or have used within the past 3 months, an automated insulin delivery system (consisting of a continuous glucose monitor and an insulin pump as well as an automated insulin delivery algorithm)
  • Clinical care provided at UH Cleveland Medical Center
  • Has not previously worked with a community health worker for help with diabetes technology

Exclusion criteria

  • Clinical diagnosis of Type 2 or monogenic diabetes
  • Completed high school
  • At least 1 parent/guardian or family support person not willing to participate
  • Non-English speaking guardians
  • Has not used automated insulin delivery within the past 3 months
  • Has previously worked with a CHW for help with diabetes technology
  • Custody of children and family services

Treatment and study plan

Community Health Worker

Other

Community Health Worker will meet with families monthly (and more often as needed) in the role of a diabetes technology coach

Primary outcomes

  1. Change in capillary HbA1c

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

  2. Change in number of participants who use an automated insulin delivery system with at least 80% time in automated mode over the past 30 days, as measured by download of data from the automated insulin delivery system

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

Secondary outcomes

  1. Change in time in range (70-180 mg/dL) as measured by continuous glucose monitoring

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

    Time in range (70-180 mg/dL) will be assessed over the 30 day increment prior to each study visit

  2. Change in time under 70 mg/dL as measured by continuous glucose monitoring

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

    Time under 70 mg/dL will be assessed over the 30 day time increment prior to each study visit

  3. Change in time over 250 mg/dL as measured by continuous glucose monitoring

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

    Time above 250 mg/dL will be assessed over the 30 day increment prior to each study visit

  4. Change in continuous glucose monitor wear time as measured by continuous glucose monitoring

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

    Wear time will be assessed over the 30 day increment prior to each study visit

  5. Change in time in automated mode as measured by automated insulin delivery system

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

    Time in automated mode will be assessed over the 30 day increment prior to each study visit.

  6. Change in psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents/guardians

    Time frame: Baseline, 6 months

    Description: 25-item questionnaire using a 3-point Likert scale, with one being not true and 3 being certainly

  7. Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale

    Time frame: Baseline, 6 months

    19-item questionnaire using 3-point Likert scale, where 1 is almost never and 3 is almost always

  8. Change in child/adolescent quality of life, as measured by PedsQL Type 1 diabetes module by parent-proxy

    Time frame: Baseline, 6 months

    28-item questionnaire using 5-point Likert scale, where 0 is almost never a problem and 4 is almost always a problem

  9. Change in parental burden related to diabetes, as measured by Problem Areas in Pediatric Diabetes - Parent Revised Version

    Time frame: Baseline, 6 months

    18-item questionnaire using 5-point Likert scale, where 0 is agree and 4 is disagree

  10. Change in medical distrust, as measured by the Group Based Medical Distrust Scale

    Time frame: Baseline, 6 months

    12-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree

  11. Change personal frequency of discrimination in healthcare, as measured by the Racism in Healthcare Index

    Time frame: Baseline, 6 months

    7-item questionnaire regarding frequency of discrimination in healthcare ranging from never to 4 times or more in a lifetime

  12. Change in perceptions of racism in healthcare, as measured by the Racism in Healthcare Index

    Time frame: Baseline, 6 months

    4-item questionnaire using 5 point Likert scale where 1 is strongly disagree and 5 is strongly agree

  13. Change in diabetes specific attitudes towards technology as measured by the Diabetes Specific Technology Attitudes Scale

    Time frame: Baseline, 6 months

    5-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree

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

    Time frame: Baseline, 6 months

    19-item yes/no questionnaire

  15. Change in diabetes management self-efficacy as measured by the Self-Efficacy for Diabetes Self-Management scale short version

    Time frame: Baseline, 6 months

    10-item questionnaire using 6-point Likert scale, where 1 is "very sure I can't" and 6 is "very sure I can"

  16. Change in Benefits and Burdens of CGM as measured by Benefits and Burdens of CGM scale

    Time frame: Baseline, 6 months

    16-item questionnaire using 5-point Likert scale, where 1 is strongly disagree and 5 is strongly agree

  17. 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.

  18. Episodes of severe hypoglycemia as measured by chart review

    Time frame: Up to 12 months

    Unconscious or having a seizure due to hypoglycemia

Other outcomes

  1. Number of meetings with community health worker

    Time frame: Up to 6 months

  2. Duration in hours/minutes of meetings with community health worker

    Time frame: Up to 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Hutter, RN

CONTACT

[email protected]

216-844-3661

Wendy Campbell, RN, CDCES

CONTACT

[email protected]

216-844-3661

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Utilizing a Community Health Worker in the Role of a Diabetes Technology Coach for Black Children Using Automated Insulin Delivery and Not Meeting Glycemic Targets (CHWs AID Youth)

Acronym: CHWs AID Youth

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2025
Registry last updated
Dec 4, 2025

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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