Implementation of Team Clinic for Type 2 Diabetes (TCT2)

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT06923046
• Lead Sponsor: Children's Hospital Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Study Start: 2025-07-01
• Primary Completion: 2027-05-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average number of clinics attended over 1 year period to be recorded by Study Coordinator	1 year	Data collected is the number of patient visits to the clinic.
Change in HbA1c for patients from baseline to end of study	1 year	Patients' glycemic outcomes will be taken every session (Visit 0 (baseline) - Visit 4) over a one-year period
Clinic Satisfaction	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Depression score	1 year	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.
Mean time-in-range from blinded 14-day continuous glucose monitoring (CGM) for Patients between baseline and 1 year	1 year	A blinded CGM device will be applied to patients at enrollment and at the final study visit to capture glycemic control
Diabetes distress for patients over 1 year period	1 year	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.
Change in dietary intake for patients before and after delivery of the dietary intervention	three months	The Dietary Screen Questionnaire (DSQ) will be administered to track changes in food habits before and after delivery of the intervention (session 2).
Beliefs about Medicines for patients and parent/caregiver over one year	1 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.
Quality of life for patients	1 year	The Pediatric Quality of Life Inventory 3.2 (PedsQL 3.2) will be administered to assess changes in diabetes symptoms and management.

Trial Locations

Locations (2)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States