Implementation of Team Clinic for Type 2 Diabetes (TCT2)

NCT06923046 | Recruiting

• 1 other identifier: CHLA-25-00070
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to learn 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:

• Is shared medical appointments an acceptable care delivery model for this population?
• Does shared medical appointment improve psychosocial outcomes for this population? Participants will attend quarterly clinic appointments and group activities and take surveys. Researchers will compare this intervention to standard of care.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• Average number of clinics attended over 1 year period to be recorded by Study Coordinator

  Data collected is the number of patient visits to the clinic.

  1 year

• Change in HbA1c for patients from baseline to end of study

  Patients' glycemic outcomes will be taken every session (Visit 0 (baseline) - Visit 4) over a one-year period

  1 year

• Clinic Satisfaction

  Patient participants will complete satisfaction survey at the end of each visit using a 5-point Likert scale; "Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5.

  1 year

Secondary Outcomes (6)

• Depression score

  1 year

• Mean time-in-range from blinded 14-day continuous glucose monitoring (CGM) for Patients between baseline and 1 year

  1 year

• Diabetes distress for patients over 1 year period

  1 year

• Change in dietary intake for patients before and after delivery of the dietary intervention

  three months

• Beliefs about Medicines for patients and parent/caregiver over one year

  1 year

Other Outcomes (12)

• Patient experience for patient and parent/caregiver

  1 year

• Demographic for Patients and Parents/Caregivers

  baseline

• Sociodemographic History for Parents/Caregivers

  baseline

Study Arms (2)

Standard Care

PLACEBO COMPARATOR

Multidisciplinary team based care every 3 months.

Other: Standard of Care

Shared Medical Appointment

ACTIVE COMPARATOR

Participants will attend 4 quarterly appointments. In addition to time with their clinician, they will also have group activities that address relevant topics.

Behavioral: Shared Medical Appointments

Interventions

Standard of Care OTHER

Multidisciplinary team based care every 3 months.

Standard Care

Shared Medical Appointments BEHAVIORAL

Participants will attend 4 quarterly appointments. In additionto time with their clinician, they will also have groupactivities that address relevant topics.

Shared Medical Appointment

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Receives care for type 2 diabetes at either CHLA or UCSF
• English speaking youth
• Youth prescribed medication for type 2 diabetes
• English or Spanish speaking caregivers
• Age 12 to 18 years old at the time of enrollment
• Willingness to attend clinic visits and participate in group session (if randomized to Team Clinic), complete surveys

You may not qualify if:

• Participants who are non-verbal or unable to participate in group activities and discussions
• Pregnancy
• Inability or unwillingness of individual or legal guardian/representative to give written informed assent/consent
• Caregiver/Parents Participants
• Has a child between the ages of 12 and up to 18 at the time of enrollment who receives care for T2D in the endocrinology clinic at CHLA. The child must provide consent/assent to participate as a youth participant.
• Speaks English of Spanish. Over 95% of our T2D population speaks one of those two languages. Our facilitator will be bilingual in English and Spanish. It is not feasible for the facilitator to also speak another language. Having a language interpreter for discussion groups will affect the dynamics and flow of the group session
• Willingness to participate in group session (if their child is randomized to Team Clinic) and complete surveys.
• Inability or unwillingness of individual to give written informed consent

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• University of California, San Francisco: collaborator
• American Diabetes Association: collaborator

Study Sites (2)

Children's Hospital Los Angeles

Los Angeles, California, 91316, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143-0434, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care; Shared Medical Appointments

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Patient Care; Therapeutics; Appointments and Schedules; Organization and Administration; Practice Management, Medical; Practice Management; Professional Practice

Study Officials

• Lily Chao, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatima Aguilar

CONTACT

323-361-4606; faguilar@chla.usc.edu

Lily Chao, MD

CONTACT

323-361-4606; chao@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 11, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)