Designing Team Clinic for Youth With Type 2 Diabetes

The goal of this study is to learn about if shared medical appointment is an acceptable way to deliver care to youth with type 2 diabetes.

The main question[s] it aims to answer are:

• Design four group activities centered around nutrition therapy, peer interactions, exercise and stress management.
• Design the clinical workflow for implementation phase.

Participants will attend quarterly clinic appointments and group activities and take surveys. Researchers will compare this intervention to standard of care.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Standard of Care; Behavioral: Shared Medical Appointments

• Study Type: Observational
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
    • San Francisco, California, United States, 94518
      • UCSF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

AYA Advisory Council: Participants will include AYAT2D between the ages of 12 to 18.

Caregiver Advisory Group: Participants will include caregivers of AYAT2D.

The Stakeholder Advisory Board will include the PI, co-I's, study coordinator, group facilitators (including Certified Diabetes Care and Education Specialists [CDCES], RD, and behavioral health specialist [BH: psychologist and social worker]), clinicians, and clinic administrator.

The Curriculum Reviewers will include CDCESs, nurses, nurse practitioners, dieticians, social workers or physicians in the diabetes clinic.

Description

AYA Advisory Council Inclusion Criteria

• Age 12 to 18 at time of study enrollment
• Receives care for type 2 diabetes
• Willingness to attend all meetings
• English-speaking

Exclusion Criteria • Non-verbal or unable to participate in group activities and discussions

Caregiver Advisory Council Inclusion Criteria

• Age 18 or above
• Caregiver of AYA with type 2 diabetes
• Willingness to attend all meetings
• English- or Spanish-speaking

Exclusion Criteria

• Non-verbal or unable to participate in group activities and discussions

Stakeholder Advisory Board Inclusion Criteria

• Age 18 or above
• On staff at CHLA or UCSF
• Clinical or administrative member of the diabetes clinic
• Willingness to participate in monthly meetings. If unable to attend, willingness to review meeting minutes.

Exclusion Criteria • None

Curriculum Reviewers Inclusion Criteria

• Age 18 or above
• CDCESs, nurses, nurse practitioners, dieticians, social workers or physicians in the diabetes clinic
• Clinical members of the diabetes clinic

Exclusion Criteria

• Member of the Stakeholder Advisory Board

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Adolescents and Young Adult Advisory Council; Youth with type 2 diabetes between the ages of 12 to 18.
Care Giver Advisory Council; Care givers of youth with Type 2 diabetes.
Curriculum Reviewers; Multidisciplinary team members (including dieticians, clinicians, social workers, and nurses) that take care of patients with type 2 diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Design four group activities for Team Clinic for youth with type 2 diabetes	Activities will be prepared for the focus group for the following topics 1. Nutrition Therapy, 2. Peer Interactions, 3. Exercise, 4. Stress Management.	Baseline to 5 months
Design Team Clinic for youth with type 2 diabetes workflow	Team Clinic in a multidisciplinary care model that includes 1) individual encounter with clinician, 2) group activity, 3) caregiver group discussion, 4) option to consult with nurse, dietician, and/or behavioral health specialist.	Baseline to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression score over 1 year	The patient health questionnaire-9 is a measure of depression severity that will be administered at baseline and again at the end of the study	baseline to 1 year
Diabetes distress over 1 year period	The Diabetes Distress Scale 2 is a 2 question prescreen that will be used to prescreen emotional burden. A score of 3 or higher on the DDS-2 will lead to the use of the 17-item survey.	baseline to one year
Change in diabetes strength and resilience (DSTAR) over 1 year	The diabetes strength and resilience (DSTAR) questionnaire will be administered to youth between 12 to 13 years. The DSTAR-Teen will be administered for youth between the ages of 14-18.	baseline to one year
Change in dietary intake over one year period	The Dietary Screen Questionnaire (DSQ) will be administered to track changes in food habits between baseline and one year.	baseline to one year
Beliefs about Medicines over one year	Beliefs about Medicines Questionnaire (BMQ) is used to any change in patients beliefs and concerns about medications. It has been validated as a proxy for medication adherence.	baseline to one year
Quality of Life over one year	The Pediatric Quality of Life Inventory 3.2 (PedsQL 3.2) will be administered to assess changes in diabetes symptoms and management.	baseline to one year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c over 1 year period	Patients' glycemic outcomes will be taken every session (4xs) over a one-year period	baseline to one year
Mean time-in-range from blinded 14-day continuous glucose monitoring (CGM) between baseline and 1 year	A blinded CGM device will be applied to patients at enrollment and at the final study visit to capture glycemic control	baseline to one year
Patient experience over one year	The Consumer Assessment of Healthcare Providers & Systems survey (CAHPS) assesses patient-clinician communication, experiences of discrimination based on race/ethnicity, insurance, and experiences leading to trust or distrust. Patient experience will be compared between control and intervention groups, both at baseline and at one year.	Baseline to one year

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Lily Chao, MD, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2024
• Primary Completion (Actual): December 30, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: shared medical appointments; youth onset type 2 diabetes; group appointments; pediatric type 2 diabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CHLA-24-00160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No