Type 2 DiabetesNCT06923046
Implementation of Team Clinic for Type 2 Diabetes (TCT2)
A study testing Shared Medical Appointments in people with Type 2 Diabetes, run by Children's Hospital Los Angeles at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Shared Medical Appointments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Aug 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
- -Inability or unwillingness of individual to give written informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 91316
Lily Chao, MD, MS
- Not yet recruiting
University of California, San Francisco
San Francisco, California, 94143-0434
About this study
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
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
- Being tested
- Standard of Care, Shared Medical Appointments
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Multidisciplinary team based care every 3 months.
Shared Medical AppointmentsBehavioural
Participants will attend 4 quarterly appointments. In additionto time with their clinician, they will also have groupactivities that address relevant topics.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Placebo comparator | Multidisciplinary team based care every 3 months. Receives: 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. Receives: Behavioral: Shared Medical Appointments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 1 year
Secondary outcomes (6)
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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start14 Aug 2025
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, American Diabetes Association
- Responsible party
- Principal investigator, lily chao, Children's Hospital Los Angeles
- Investigators
- Lily Chao, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923046
- Sponsor's protocol ID
- CHLA-25-00070
- Status last verified
- Oct 2025
- First submitted
- 25 Mar 2025
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06923046
- Acronym / sponsor ID
- CHLA-25-00070
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- University of California, San Francisco, American Diabetes Association
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Placebo comparator | Other: Standard of CareMultidisciplinary team based care every 3 months. |
| Shared Medical Appointment | Active comparator | Behavioral: Shared Medical AppointmentsParticipants will attend 4 quarterly appointments. In addition to time with their clinician, they will also have group activities that address relevant topics. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- -Inability or unwillingness of individual to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareMultidisciplinary team based care every 3 months. | Other | Standard Care |
| Shared Medical AppointmentsParticipants will attend 4 quarterly appointments. In additionto time with their clinician, they will also have groupactivities that address relevant topics. | Behavioural | Shared Medical Appointment |
Primary outcome
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.
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
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lily Chao, MD principal investigator
Children's Hospital Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Medical Appointments in people with Type 2 Diabetes, run by Children's Hospital Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatima Aguilar (323-361-4606, faguilar@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of clinics attended over 1 year period to be recorded by Study Coordinator (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.