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

Not Applicable

Not yet recruiting

• Conditions: Type 1 Diabetes (T1D)

• Registration Number: NCT07154251
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Study Start: 2025-09-15
• Primary Completion: 2027-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in capillary HbA1c	Baseline, 3 months, 6 months, 9 months, 12 months
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	Baseline, 3 months, 6 months, 9 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Change in time in range (70-180 mg/dL) as measured by continuous glucose monitoring	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
Change in time under 70 mg/dL as measured by continuous glucose monitoring	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
Change in time over 250 mg/dL as measured by continuous glucose monitoring	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
Change in continuous glucose monitor wear time as measured by continuous glucose monitoring	Baseline, 3 months, 6 months, 9 months, 12 months	Wear time will be assessed over the 30 day increment prior to each study visit
Change in time in automated mode as measured by automated insulin delivery system	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.
Change in psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents/guardians	Baseline, 6 months	Description: 25-item questionnaire using a 3-point Likert scale, with one being not true and 3 being certainly
Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale	Baseline, 6 months	19-item questionnaire using 3-point Likert scale, where 1 is almost never and 3 is almost always
Change in child/adolescent quality of life, as measured by PedsQL Type 1 diabetes module by parent-proxy	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
Change in parental burden related to diabetes, as measured by Problem Areas in Pediatric Diabetes - Parent Revised Version	Baseline, 6 months	18-item questionnaire using 5-point Likert scale, where 0 is agree and 4 is disagree
Change in medical distrust, as measured by the Group Based Medical Distrust Scale	Baseline, 6 months	12-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Change personal frequency of discrimination in healthcare, as measured by the Racism in Healthcare Index	Baseline, 6 months	7-item questionnaire regarding frequency of discrimination in healthcare ranging from never to 4 times or more in a lifetime
Change in perceptions of racism in healthcare, as measured by the Racism in Healthcare Index	Baseline, 6 months	4-item questionnaire using 5 point Likert scale where 1 is strongly disagree and 5 is strongly agree
Change in diabetes specific attitudes towards technology as measured by the Diabetes Specific Technology Attitudes Scale	Baseline, 6 months	5-item questionnaire using 5 point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Change in barriers to technology as measured by Barriers to Technology Checklist	Baseline, 6 months	19-item yes/no questionnaire
Change in diabetes management self-efficacy as measured by the Self-Efficacy for Diabetes Self-Management scale short version	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"
Change in Benefits and Burdens of CGM as measured by Benefits and Burdens of CGM scale	Baseline, 6 months	16-item questionnaire using 5-point Likert scale, where 1 is strongly disagree and 5 is strongly agree
Episodes of Diabetic Ketoacidosis as measured by chart review	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.
Episodes of severe hypoglycemia as measured by chart review	Up to 12 months	Unconscious or having a seizure due to hypoglycemia

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States