Collaborative Care Model for Diabetes

Overseen By Deborah J Wexler, MD, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Gestational diabetes, Pregnancy, MODY, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing diabetes in young adults. It compares an innovative care model, the Diabetes Collaborative Care Model for Young Adults, to the usual care at Massachusetts General Hospital Diabetes Center. The goal is to determine if the new model improves diabetes management and outcomes. Ideal participants are young adults aged 18-30 with type 1 or type 2 diabetes who are new patients at this hospital. As an unphased trial, this study allows participants to contribute to pioneering research that could enhance diabetes care for young adults.

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 model is safe for young adults with diabetes?

Research has shown that the Diabetes Collaborative Care Model for Young Adults is generally safe. This model combines diabetes care with mental health support and has proven effective and acceptable for young adults with type 1 diabetes. No major reports of negative effects have been linked to this care model, indicating that patients handle it well. Overall, evidence supports the safety of this new approach to managing diabetes in young adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Diabetes Collaborative Care Model for Young Adults because it takes a team-based approach to managing diabetes, which is different from the usual care where patients mainly see one primary doctor. This model integrates various healthcare professionals, such as dietitians, pharmacists, and mental health experts, working together to provide personalized and comprehensive care. By focusing on young adults, this approach aims to address the unique lifestyle and emotional challenges they face, potentially leading to better diabetes control and overall health outcomes.

What evidence suggests that this trial's care models could be effective for diabetes?

Research has shown that a team-based approach to diabetes care can be effective for young adults. In this trial, participants in the Diabetes Collaborative Care Model for Young Adults arm will experience this approach, where different health professionals work together to help reduce heart-related risks in people with diabetes. It also encourages patients to actively manage their own health. Studies have found that using technology in this team-based care improves the connection between patients and their healthcare providers. Although more high-quality research is needed, early results suggest this method can lead to better health outcomes for young adults with diabetes. Meanwhile, participants in the Usual Care Model arm will receive standard diabetes care at the Massachusetts General Hospital (MGH) Diabetes Center. ^{1 6 7 8 9}

Who Is on the Research Team?

Deborah J Wexler, MD, MSc

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-30 with Type 1 or Type 2 diabetes, who manage their own diabetes and are new patients at MGH Diabetes Center as of September 2021. It's not for pregnant individuals, non-English speakers, those with other forms of diabetes or significant disabilities requiring others to manage their care.

Inclusion Criteria

I have diabetes (type 1 or type 2).

You must be able to take care of your diabetes on your own.

The patient does not have to be diagnosed with diabetes in youth or have been previously seen at MGH for Children (MGHfC) Pediatric Diabetes Clinic to be included

Exclusion Criteria

Someone else manages my diabetes care most of the time due to my disability.

I have type 2 diabetes and manage it with diet or just metformin, unless I was diagnosed within the last year.

Non-English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive diabetes care per the diabetes collaborative care model or usual care model

12 months

Regular visits as per care model

Follow-up

Participants are monitored for changes in HbA1c, mood, diabetes-related distress, alcohol use, anxiety, and disordered eating behavior

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Collaborative Care Model for Young Adults
• Usual Care Model

Trial Overview The study tests a new Diabetes Collaborative Care Model against the usual care model at MGH Diabetes Center. The goal is to see how well the innovative model works and compare health outcomes between the two groups.

How Is the Trial Designed?

Group I: Diabetes Collaborative Care Model for Young Adults Active Control 1 Intervention

Patients enrolled in this arm will receive diabetes care per the diabetes collaborative care model for young adults.

Group II: Usual Care Model Active Control 1 Intervention

Patients enrolled in this arm will receive diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317239/

Evaluating the feasibility of a co-designed technology-enabled ... The TECC-T1D3 study will determine whether a TECC model is feasible and acceptable for young adults with T1D and DD. Keywords: Type 1 diabetes, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5484309/

A systematic review of interventions to improve outcomes ... This review has highlighted a lack of high‐quality, well‐designed interventions, aimed at improving health outcomes for young adults with Type 1 diabetes.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07181863

Technology-Enabled Collaborative Care for Diabetes and ... This model enhances the core relationship between provider and patients while empowering the person to be an active agent in their health and ...

4. diabetesjournals.org diabetesjournals.org/care/article/48/Supplement_1/S14/157553/1-Improving-Care-and-Promoting-Health-in

1. Improving Care and Promoting Health in Populations Young. DYL . Effectiveness of the chronic care model for adults with type 2 diabetes in primary care: a systematic review and meta-analysis.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1751991824001116

The effects of multidisciplinary collaborative care on ... Multidisciplinary collaborative care is associated with reduced cardiovascular risk factors among patients with diabetes in primary care.

6. researchgate.net researchgate.net/publication/394105617_Evaluating_the_feasibility_of_a_co-designed_technology-enabled_collaborative_care_program_for_young_adults_with_type_1_diabetes_and_diabetes_distress_A_protocol

Evaluating the feasibility of a co-designed technology ... This study aims to evaluate the feasibility and acceptability of the co-designed technology-enabled collaborative care model (TECC-T1D3) ...

7. clinicaltrial.be clinicaltrial.be/en/details/33131?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Understanding and Optimizing Care for Young Adults With ... We designed a diabetes collaborative care model for young adults that incorporates a mental health provider alongside a diabetes care provider ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11868000/

Young Adults with Type 1 Diabetes' Clinical Outcomes and ... We aimed to evaluate clinical outcomes and satisfaction related to the use of videoconferencing for T1D healthcare in YAT1D.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06448429

NCT06448429 | Testing an Integrated Care Model Trial This study aims to test the use of an adapted collaborative care model for improving the health outcomes of adults diagnosed with type 1 diabetes (T1D).