Implementation of Team Clinic for Type 2 Diabetes (TCT2)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of Care, Shared Medical Appointments.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Other Standard of Care
Multidisciplinary team based care every 3 months. - 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.
Primary outcome measures
- Average number of clinics attended over 1 year period to be recorded by Study Coordinator [Time frame: 1 year]
- Change in HbA1c for patients from baseline to end of study [Time frame: 1 year]
- Clinic Satisfaction [Time frame: 1 year]
Secondary outcome measures (6)
- Depression score [Time frame: 1 year]
- Mean time-in-range from blinded 14-day continuous glucose monitoring (CGM) for Patients between baseline and 1 year [Time frame: 1 year]
- Diabetes distress for patients over 1 year period [Time frame: 1 year]
- Change in dietary intake for patients before and after delivery of the dietary intervention [Time frame: three months]
- Beliefs about Medicines for patients and parent/caregiver over one year [Time frame: 1 year]
- Quality of life for patients [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 2 centers
- Children's Hospital Los Angeles — Los Angeles
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT06923046 · CHLA-25-00070