Clinical trial Recruiting at 4 sites Interventional Ages 10 to 14

Family intervention for Black teens with type 1 diabetes

Official title: Family mHealth Intervention to Improve Health Outcomes in Black Youth With Type 1 Diabetes

Run by Wayne State University · NCT06275412 · Data updated 2026-11-12

This study is testing a new mobile health program to see if it can help Black teens with type 1 diabetes manage their blood sugar better and improve their family relationships.

Quick facts

Study typeInterventional
Ages10 Years to 14 Years
SexAll
Enrollment216 (estimated)
SponsorWayne State University
Academic / other
Locations4 sites (Washington D.C., District of Columbia and 3 other locations)
StatusRecruiting
StartedSeptember 16, 2024
Main results expectedApril 30, 2028
Study endsApril 30, 2028
Registry record updatedAugust 27, 2026
Trial IDNCT06275412 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are Black adolescents aged 10 to 14 years diagnosed with type 1 diabetes for at least six months, along with their willing primary caregivers.

Probably not a fit

Patients with mental health conditions that could affect data integrity or those with co-morbid conditions affecting diabetes management may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of The 3Ms 2.0 intervention, delivered via mobile health technology, in improving glycemic control and family relationships among Black adolescents with type 1 diabetes and their primary caregivers. It is a multicenter, randomized controlled trial involving 216 adolescent-caregiver dyads, who will be assigned to either the intervention group or an educational control group. The intervention consists of three brief sessions aimed at enhancing parental supervision of diabetes management, while the control group receives general diabetes education. The trial is conducted at two sites, with Wayne State University overseeing the management.

Why it matters

Potential benefit: If successful, this intervention could lead to improved diabetes management and reduced caregiver distress for Black adolescents with type 1 diabetes.

How similar studies have gone: Other studies have shown promise in family-based interventions for diabetes management, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age: 10 years, 0 months - 14 years, 11 months
* Diagnosed with Type 1 diabetes
* Diagnosed for at least 6 months
* Black
* Primary caregiver willing to participate
* Residence within 30 miles of a recruitment site
* Caregiver ownership of an Internet-enabled device (cell phone, laptop or desktop computer, tablet, etc)

Exclusion Criteria:

* Mental health conditions that might compromise data integrity (e.g., developmental delay, schizophrenia, psychosis, current suicidality, homicidality)
* Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis)
* Inability to speak or read English
* Child is in out-of-home placement

Where it's running

  • Children's National Hospital
    Washington D.C., District of Columbia, United States
    Recruiting
  • Wayne Pediatrics
    Detroit, Michigan, United States
    Recruiting
  • LeBonheur Children's Hospital
    Memphis, Tennessee, United States
    Recruiting
  • University of Tennessee Health Science Center-Memphis
    Memphis, Tennessee, United States
    Recruiting

Study contacts

  • Principal investigator: Deborah A Ellis, Ph.D. — Wayne State University
  • Study coordinator: Deborah A Ellis, Ph.D.
  • Email: dellis@med.wayne.edu
  • Phone: 313-577-1055

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.