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NCT05431686Completed

Group Visits for High Risk Type 1 Diabetes (T1D)

Group Visits to Improve Technology Use, Glycemic Control, and Quality of Life in High Risk Children With Type 1 Diabetes

Source: ClinicalTrials.gov · Last updated 22 Dec 2025

Brief summary (registry, in English)

The investigators propose to conduct a pilot prospective cohort study to assess the impact of shared medical appointments (SMA) visits in underserved youth with poorly controlled type 1 diabetes (T1D). The trial will employ an enrollment visit, SMA visits every 3 months over a 12 month study period, followed by a 6-month observational period to assess feasibility and acceptability of SMA and the impact on glycemic control, self-management skills, and health related quality of life.

Status (registry)
Completed
Study type
Interventional
Enrollment
14 (actual)
First submitted
18 Mar 2022
Start date
16 Feb 2022
Primary completion date
1 Jul 2025
Lead sponsor
Children's National Research Institute
NCT number
NCT05431686

What you commit to

  • Study type: Interventional
  • Participants enrolled: 14
  • From 16 Feb 2022 to the primary completion date, 1 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent participation in any other clinical studies during study period

Other illness

  • 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

Lab values

  • Concurrent use of any non-insulin diabetes medication to control blood glucose levels.

Who the study is looking for

  • 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

Age in the registry: 8 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Children's National Hospital
Coordinator of this site? Confirm its status
Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.