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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.

Wendy Campbell, RN, CDCES contact

216-844-3661

wendy.campbell@uhhospitals.org

Julie Hutter, RN contact

216-844-3661

julie.hutter@uhhospitals.org

United States1 site, 1 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

    Recruiting

Other trials in United States

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.

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 groups in NCT07154251
Study groupRoleWhat they receive
Community Health WorkerExperimentalCommunity 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.

  1. Change in capillary HbA1c

    Measured: 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

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months

Secondary outcomes (18)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

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

    19-item yes/no questionnaire

    Measured: Baseline, 6 months

  15. 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

  16. 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

  17. 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

  18. 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.

  1. First posted4 Sep 2025
  2. Study start6 Nov 2025
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wendy Campbell, RN, CDCES (216-844-3661, wendy.campbell@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in capillary HbA1c (time frame: Baseline, 3 months, 6 months, 9 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07154251.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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