Team Clinic Care for Type 1 Diabetes

Overseen By Valerie Ruelas, MSW

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Severe disabilities, Psychological diagnoses, Comorbid conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 months

79 Participants Needed

Trial Summary

What is the purpose of this trial?

Team Clinic is a new care approach for middle and high school aged patients living with T1D and their families. This study is a 15-month randomized control trial (RCT) that consists of Virtual Team Clinic Care appointments (primarily telemedicine, and in-person as necessary) and Virtual Team Clinic group appointments with a multidisciplinary diabetes care team. Assignment into 1 of 4 intervention groups Team Clinic Care vs. Standard Care which consist of either Virtual Team Clinic Group or no group. Groups: 1. Standard Care - No Group 2. Standard Care - Virtual Team Clinic Group 3. Team Clinic Care - No Group 4. Team Clinic Care - Virtual Team Clinic Group Virtual Team Clinic group sessions will be facilitated by clinical care team (e.g., Registered Dietician, Social Worker, Registered Nurse, etc.) * Patients and parents will attend their own online session

Research Team

Jennifer K Raymond, MD, MCR

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

This trial is for English-speaking middle and high school students with Type 1 Diabetes, who have been diagnosed for over 6 months. They shouldn't be in other group interventions or have serious medical conditions like cystic fibrosis, uncontrolled thyroid disease, or severe behavioral/psychological issues that could affect group participation.

Inclusion Criteria

I am currently in grades 6 through 12.

I have been diagnosed with type 1 diabetes for over 6 months.

English speaking

Exclusion Criteria

The parent or child has serious behavior or learning challenges.

I do not have major health issues like cystic fibrosis or uncontrolled thyroid disease.

Either my child or I have a severe mental health condition that makes group activities challenging.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Virtual Team Clinic Care appointments and group sessions aimed at improving glycemic control and treatment adherence

12 months

Quarterly visits (1 visit every 3 months), primarily telemedicine

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Standard Care
• Team Clinic Care

Trial Overview The study tests a new 'Team Clinic' care approach against standard care for managing Type 1 Diabetes. It involves virtual appointments and possibly in-person visits with a multidisciplinary team. Participants are randomly placed into one of four groups to compare the effects of these different approaches over 15 months.

Participant Groups

Group I: Team Clinic: Virtual Team Clinic Group Experimental Treatment 1 Intervention

Participants will be invited to participate in online/virtual thematic group sessions led by Team Clinic group facilitators (e.g., RD, SW, RN) aimed at improving glycemic control and treatment adherence, increasing social supports and diabetes care satisfaction, and aid in the transition from caregiver led treatment to self care. o Patients and Family members attend their own online sessions: Energy Training, Proficiency Training, Resilience Training, Balance Training, Miscellaneous sessions - scheduled as needed

Group II: Team Clinic Care: No VTC Groups Experimental Treatment 1 Intervention

Participants attend quarterly visits (1 visit every 3months). Appointments scheduled for Telehealth (TH) (1 in-person visits) as decided by provider/patient and yearly team visit as needed • Providers will utilize a patient centered care approach to conducting appointments

Group III: Standard Care: Virtual Team Clinic Experimental Treatment 1 Intervention

Appointments will continue as usually with provider (quarterly visits; 1 visit every 3 months), but will be referred for necessary care per usual methods (e.g., diabetes education or supportive services). o Patients and Family members attend their own online sessions: Energy Training, Proficiency Training, Resilience Training, Balance Training, Miscellaneous sessions - scheduled as needed

Group IV: Standard Care: No VTC Groups Experimental Treatment 1 Intervention

Appointments will continue as usually with provider (quarterly visits; 1 visit every 3 months), but will be referred for necessary care per usual methods (e.g., diabetes education or supportive services).

Standard Care is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Varenicline for:

• Smoking cessation

Approved in European Union as Champix for:

• Smoking cessation

Approved in Canada as Champix for:

• Smoking cessation

Approved in Japan as Champix for:

• Smoking cessation

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+