Implementation of Team Clinic for Type 2 Diabetes (TCT2)

Implementation of Team Clinic for Type 2 Diabetes (TCT2): A Randomized Standard Care-controlled Two-site 80-subject Clinical Trial of Shared Medical Appointment Model for Adolescents With Type 2 Diabetes

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatima Aguilar; Phone Number: 323-361-4606; Email: faguilar@chla.usc.edu
• Study Contact Backup: Name: Lily Chao, MD; Phone Number: 323-361-4606; Email: chao@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 91316
      • Recruiting
      • Children's Hospital Los Angeles
      • Principal Investigator: Lily Chao, MD, MS
    • San Francisco, California, United States, 94143-0434
      • Not yet recruiting
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

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

Description

Patient/AYA Participants

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Inclusion Criteria:

• 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.

Exclusion Criteria:

-Inability or unwillingness of individual to give written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standard Care; Multidisciplinary team based care every 3 months.	Other: Standard of Care; Multidisciplinary team based care every 3 months.
Active Comparator: Shared Medical Appointment; 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; Participants will attend 4 quarterly appointments. In additionto time with their clinician, they will also have groupactivities that address relevant topics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression score	The patient health questionnaire-8 is a measure of depression severity that will be administered at baseline and again at the end of the study.	1 year
Mean time-in-range from blinded 14-day continuous glucose monitoring (CGM) for Patients 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	1 year
Diabetes distress for patients 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.	1 year
Change in dietary intake for patients before and after delivery of the dietary intervention	The Dietary Screen Questionnaire (DSQ) will be administered to track changes in food habits before and after delivery of the intervention (session 2).	three months
Beliefs about Medicines for patients and parent/caregiver 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.	1 year
Quality of life for patients	The Pediatric Quality of Life Inventory 3.2 (PedsQL 3.2) will be administered to assess changes in diabetes symptoms and management.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient experience for patient and parent/caregiver	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.	1 year
Demographic for Patients and Parents/Caregivers	Self-reported demographic history (date of birth, gender, race and/or ethnicity, education, etc) will be collected.	baseline
Sociodemographic History for Parents/Caregivers	Self-reported sociodemographic history (work status, marital members, household income, etc)	baseline
Implementation Outcome Measures for Research Staff	Implementation Outcome measure is used in behavioral health care as a psycho metric quality and will be used to assess how effectively clinic is being implemented.	At end of study (end of 1 year)
Parent/Caregiver Clinic Satisfaction Survey	Survey will assess clinic satisfaction experience after each visit though a likert scale. Likert scale; "Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5.	1 year
Shared Decision Making for Team Clinic Patients and Parents/Caregivers over one year	Shared decision making tool assess AYA and parent/caregiver's priorities for each medical visit using a mix of multiple choice and open-ended questions.	1 year
Research Team Appointment Satisfaction Survey	Survey will assess clinic satisfaction experience after each visit though a likert scale. Likert scale; "Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5. Also, includes 4 open-ended questions to measures satisfaction for shared medical appointments.	1 year
Clinician Goals/Plans for Clinicians	Clinicians will work with families to discuss goals and plans guided by responding to 5 open-ended questions at each visit. Each member (Clinician, family, and AYA) will respond to these questions.	1 year
Healthcare Utilization Form	Healthcare Utilization Form is a 3-item survey that assess 911 call or emergency room usage for diabetic ketoacidosis, or severe hypoglycemia requiring glucagon.	1 year
Medication Review	General health history through review of participants EMR, completed by study coordinator	baseline to one year
Adverse Events Form	The adverse events form will track any ED visits related to diabetes, DKA admissions, etc. throughout the study. It will be completed by Study Coordinator	baseline to one year
Discontinuation and Termination Form	The discontinuation and termination form tracks reason for discontinuation of patient and agreement of continuation of medical records. To be completed by research coordinator.	baseline to one year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Professional Practice; Organization and Administration; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics; Quality of Health Care; Quality Indicators, Health Care; Patient Care; Appointments and Schedules; Practice Management; Practice Management, Medical; Standard of Care; Shared Medical Appointments
• Other Study ID Numbers: CHLA-25-00070

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