Type 1 Diabetes (T1D)CHWs AID YouthNCT07154251
Utilizing Community Health Workers as Diabetes Technology Coaches for Children With Type 1 Diabetes Using Automated Insulin Delivery
A study testing Community Health Worker in people with Type 1 Diabetes (T1D), run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Community Health Worker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2025to 1 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Wendy Campbell, RN, CDCES, 216-844-3661, wendy.campbell@uhhospitals.org
Julie Hutter, RN, 216-844-3661, julie.hutter@uhhospitals.org
About this study
Official 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)
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.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Community Health Worker
- Keywords
- Automated insulin delivery, Community Health Worker, Disparities, Type 1 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health WorkerOther
Community Health Worker will meet with families monthly (and more often as needed) in the role of a diabetes technology coach
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker | Experimental | Community Health Workers will meet with families monthly in the role of a diabetes technology coach, with additional visits as needed. Receives: Other: Community Health Worker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in capillary HbA1c
Measured: 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
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcomes (18)
Change in time in range (70-180 mg/dL) as measured by continuous glucose monitoring
Time in range (70-180 mg/dL) will be assessed over the 30 day increment prior to each study visit
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in time under 70 mg/dL as measured by continuous glucose monitoring
Time under 70 mg/dL will be assessed over the 30 day time increment prior to each study visit
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in time over 250 mg/dL as measured by continuous glucose monitoring
Time above 250 mg/dL will be assessed over the 30 day increment prior to each study visit
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in continuous glucose monitor wear time as measured by continuous glucose monitoring
Wear time will be assessed over the 30 day increment prior to each study visit
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in time in automated mode as measured by automated insulin delivery system
Time in automated mode will be assessed over the 30 day increment prior to each study visit.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents/guardians
Description: 25-item questionnaire using a 3-point Likert scale, with one being not true and 3 being certainly
Measured: Baseline, 6 months
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
Measured: Baseline, 6 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
Measured: Baseline, 6 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
Measured: Baseline, 6 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
Measured: Baseline, 6 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
Measured: Baseline, 6 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
Measured: Baseline, 6 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
Measured: Baseline, 6 months
Change in barriers to technology as measured by Barriers to Technology Checklist
19-item yes/no questionnaire
Measured: Baseline, 6 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"
Measured: Baseline, 6 months
Change in 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
Measured: Baseline, 6 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.
Measured: up to 12 months
Episodes of severe hypoglycemia as measured by chart review
Unconscious or having a seizure due to hypoglycemia
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start6 Nov 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pilot intervention study with use of historic controls
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah A. MacLeish, University Hospitals Cleveland Medical Center
- Investigators
- Sarah A MacLeish, DO, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154251
- Sponsor's protocol ID
- STUDY20250042
- Acronym
- CHWs AID Youth
- Status last verified
- Nov 2025
- First submitted
- 26 Aug 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study