Group visits for underserved youth with poorly controlled type 1 diabetes
Group Visits to Improve Technology Use, Glycemic Control, and Quality of Life in High Risk Children With Type 1 Diabetes
This study is testing if group medical visits can help kids aged 8-12 with poorly controlled type 1 diabetes and their caregivers manage their condition better over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 8 Years and up |
| Sex | All |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington, District of Columbia) |
| Trial ID | NCT05431686 on ClinicalTrials.gov |
What this trial studies
This pilot prospective cohort study aims to evaluate the feasibility and acceptability of shared medical appointments (SMA) for youth aged 8-12 years with poorly controlled type 1 diabetes (T1D) and their primary caregivers. Participants will attend SMA visits every three months over a 12-month period, followed by a 6-month observational phase to assess outcomes related to glycemic control, self-management skills, and health-related quality of life. The study will involve comprehensive training for staff to facilitate effective discussions during the SMA visits, and participants will wear a blinded continuous glucose monitor to gather baseline data.
Who should consider this trial
Good fit: Ideal candidates are non-Hispanic Black or Latinx youth aged 8-12 years with poorly controlled type 1 diabetes managed with insulin injections.
Not a fit: Patients using insulin pump therapy or those with significant cognitive limitations or major psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve glycemic control and quality of life for underserved youth with type 1 diabetes.
How similar studies have performed: Other studies have shown promise in using shared medical appointments for chronic disease management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients clinically diagnosed with T1D managed with insulin injections for at least 1 year * Non-Hispanic Black or Latinx ethnicity * Public healthcare insurance * Male or female ages ≥ 8 and \< 12 years * Poorly controlled T1D: one A1c value \> 8% in the preceding year * Fluent in English as the Dexcom technology is currently available only in English * Participation of the primary diabetes caregiver Exclusion Criteria: * Use of insulin pump therapy for diabetes management at time of enrollment * Major illnesses other than T1D * Significant cognitive limitations and major psychiatric disorders in the child or * Concurrent use of any non-insulin diabetes medication to control blood glucose levels. * Concurrent participation in any other clinical studies during study period
Where this trial is running
Washington, District of Columbia
- Children's National Hospital — Washington, District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Shideh Majidi, MD — Children's National Research Institute
- Study coordinator: Jody Grundman, MD
- Email: jgrundman@childrensnational.org
- Phone: 2024761036
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.