COMPLETED

Group Visits for High Risk Type 1 Diabetes (T1D)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-16

Study Completion:2025-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05431686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Shideh Majidi, MD

PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Study Locations (Sites)

Children's National Hospital

Washington D.C., District of Columbia, 20010

United States

Collaborators and Investigators

Sponsor: Children's National Research Institute

Shideh Majidi, MD, PRINCIPAL_INVESTIGATOR, Children's National Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-16

Study Completion Date2025-07-01

Study Record Updates

Study Start Date2022-02-16

Study Completion Date2025-07-01

Terms related to this study

Additional Relevant MeSH Terms

Type 1 Diabetes