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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new care approach for middle and high school students living with type 1 diabetes (T1D). It will compare standard care, which may include medications like Varenicline (also known as Chantix, Apovarenicline, Champix, or Nocrav), with a new Team Clinic Care model. This model includes virtual group sessions with a healthcare team, such as dietitians and nurses. The goal is to determine if this new approach can improve diabetes management, support, and satisfaction for both students and their families. Eligible participants are students diagnosed with T1D for over six months, who are not currently in other group treatments, and who speak English. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes care strategies.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this care approach is safe for patients with Type 1 Diabetes?

Research has shown that the Team Clinic Care approach, which includes both online and in-person sessions, is generally well-received by young people with Type 1 Diabetes (T1D). Studies have found that online diabetes clinics can improve blood sugar control and increase satisfaction with treatment, without major safety issues. Patients in these virtual settings often report positive experiences, with no serious problems. This suggests that the Team Clinic Care model is safe for young patients managing T1D. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of a Team Clinic Care approach for people with Type 1 Diabetes. Unlike traditional care, which typically involves regular check-ups and individual diabetes education, the Team Clinic model emphasizes virtual thematic group sessions. These sessions, led by healthcare professionals, aim to enhance glycemic control, improve treatment adherence, and boost social support while helping patients transition to self-care. By fostering a community environment and offering targeted training, this method might increase patient satisfaction and empowerment, potentially leading to better long-term health outcomes.

What evidence suggests that this trial's treatments could be effective for Type 1 Diabetes?

Research shows that the Team Clinic Care approach, a treatment option in this trial, can benefit young people with Type 1 Diabetes (T1D). Studies have found that a virtual diabetes clinic improves blood sugar control. This approach also enhances patient satisfaction and quality of life. Evidence suggests that a care team with various experts, such as dietitians and nurses, effectively addresses the unique challenges faced by teenagers with T1D. This team-based care model works well for diverse patients, providing personalized support to meet their needs. ^{1 2 3 6 7}

Who Is on the Research Team?

Jennifer K Raymond, MD, MCR

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11592975/

Insights from Team Clinic: A Person-Centered Virtual Peer ... Team Clinic can serve as an alternative care model for racially and ethnically diverse youth with T1D and their families.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04190368

Study Details | NCT04190368 | Team Clinic: Virtual ... 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 ...

3. bmcendocrdisord.biomedcentral.com bmcendocrdisord.biomedcentral.com/articles/10.1186/s12902-023-01516-x

Virtual clinic for young people with type 1 diabetes The primary objective of this study was to evaluate the effects of a virtual diabetes clinic on glycaemic control, treatment satisfaction, and quality of life

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714420301579

Team clinic: Expansion of a multidisciplinary care model for ... Data from the Type 1 Diabetes (T1D) Exchange indicate that adolescent and young adults (AYA) with T1D experience more difficulty with glycemic control than ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8098333/

Team clinic: Expansion of a multidisciplinary care model ... Data from the Type 1 Diabetes (T1D) Exchange indicate that adolescent and young adults (AYA) with T1D experience more difficulty with glycemic control than ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/58/NCT04765358/Prot_002.pdf

Virtual Diabetes Specialty Clinic: A Study Evaluating ... Virtual clinic team members will check in with participants during the initial six months of study follow up to review CGM data and.

7. diabetesjournals.org diabetesjournals.org/care/article/38/4/561/37514/An-Internet-Based-Diabetes-Management-Platform

An Internet-Based Diabetes Management Platform Improves ... We compared the clinical benefit of the diabetes dashboard intervention with that of a control condition providing usual diabetes care (UDC).