Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06923046

Implementation of Team Clinic for Type 2 Diabetes (TCT2)

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

Other

Multidisciplinary team based care every 3 months.

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.

Primary outcomes

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

    Time frame: 1 year

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

  2. Change in HbA1c for patients from baseline to end of study

    Time frame: 1 year

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

  3. Clinic Satisfaction

    Time frame: 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 outcomes

  1. Depression score

    Time frame: 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.

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

    Time frame: 1 year

    A blinded CGM device will be applied to patients at enrollment and at the final study visit to capture glycemic control

  3. Diabetes distress for patients over 1 year period

    Time frame: 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.

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

    Time frame: 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).

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

    Time frame: 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.

  6. Quality of life for patients

    Time frame: 1 year

    The Pediatric Quality of Life Inventory 3.2 (PedsQL 3.2) will be administered to assess changes in diabetes symptoms and management.

Other outcomes

  1. Patient experience for patient and parent/caregiver

    Time frame: 1 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.

  2. Demographic for Patients and Parents/Caregivers

    Time frame: baseline

    Self-reported demographic history (date of birth, gender, race and/or ethnicity, education, etc) will be collected.

  3. Sociodemographic History for Parents/Caregivers

    Time frame: baseline

    Self-reported sociodemographic history (work status, marital members, household income, etc)

  4. Implementation Outcome Measures for Research Staff

    Time frame: At end of study (end of 1 year)

    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.

  5. Parent/Caregiver Clinic Satisfaction Survey

    Time frame: 1 year

    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.

  6. Shared Decision Making for Team Clinic Patients and Parents/Caregivers over one year

    Time frame: 1 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.

  7. Research Team Appointment Satisfaction Survey

    Time frame: 1 year

    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.

  8. Clinician Goals/Plans for Clinicians

    Time frame: 1 year

    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.

  9. Healthcare Utilization Form

    Time frame: 1 year

    Healthcare Utilization Form is a 3-item survey that assess 911 call or emergency room usage for diabetic ketoacidosis, or severe hypoglycemia requiring glucagon.

  10. Medication Review

    Time frame: baseline to one year

    General health history through review of participants EMR, completed by study coordinator

  11. Adverse Events Form

    Time frame: baseline to one year

    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

  12. Discontinuation and Termination Form

    Time frame: baseline to one year

    The discontinuation and termination form tracks reason for discontinuation of patient and agreement of continuation of medical records. To be completed by research coordinator.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatima Aguilar

CONTACT

[email protected]

323-361-4606

Lily Chao, MD

CONTACT

[email protected]

323-361-4606

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • American Diabetes Association
  • University of California, San Francisco

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 11, 2025
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.