Understanding and Optimizing Care for Young Adults With Type 1 and Type 2 Diabetes Mellitus Transitioning to Adult Care

NCT ID: NCT05229718

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2025-11-30

Brief Summary

In this study, we will determine the feasibility of an innovative care model for young adults with diabetes and compare the primary and secondary outcomes in the innovative model to those in the usual care model for adult diabetes management at Massachusetts General Hospital (MGH) Diabetes Center.

Detailed Description

This study is a quasi-randomized mixed methods evaluation of the implementation of an innovative collaborative care model to assess whether it is feasible and improves indicators of diabetes and mental health, while exploring themes that will inform redesign of the care model to improve healthcare delivery to young adults with diabetes transitioning to the adult care setting. We will compare primary and secondary outcomes in this model to those in the usual care model for adult diabetes management at MGH Diabetes Center. Those who agree to the research study will be asked to complete a series of three survey questionnaires over the timeframe of the study. The electronic health records (EHRs) of these patients who agree to the research study will also be examined. All patients who successfully complete all 3 survey questionnaires will be eligible for a structured interview portion of the study to explore themes that will inform care model redesign.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care Model

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

Group Type: ACTIVE_COMPARATOR

Usual Care Model

Intervention Type: OTHER

Patients enrolled in this arm will receive routine diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center, with lab testing, medical interventions, therapies and referrals performed at the discretion of the patients' providers. In the usual care model, behavioral/mental health and social work services are available on a referral basis and are not integrated into a patients' routine appointment. Screening and treatment of psychosocial determinants of diabetes management are at done at the discretion of the patients' provider. Frequency of follow up visits is at the discretion of the patients' provider.

Diabetes Collaborative Care Model for Young Adults

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

Group Type: ACTIVE_COMPARATOR

Diabetes Collaborative Care Model for Young Adults

Intervention Type: OTHER

We designed a diabetes collaborative care model for young adults that incorporates a mental health provider alongside a diabetes care provider during joint office visits to facilitate screening and treatment of psychosocial determinants of diabetes management. The Massachusetts General Hospital (MGH) Diabetes Center will be piloting this model with a multi-disciplinary team of diabetologists, nurse practitioners, diabetes nurse educators, and mental health provider. Patients scheduled to be seen in the diabetes collaborative care model will continue to follow in the diabetes collaborative care model, with follow up visits every 3-4 months. All patients will receive routine diabetes care with lab testing, medical interventions, therapies and referrals performed at the discretion of the patients' providers.

Interventions

Diabetes Collaborative Care Model for Young Adults

We designed a diabetes collaborative care model for young adults that incorporates a mental health provider alongside a diabetes care provider during joint office visits to facilitate screening and treatment of psychosocial determinants of diabetes management. The Massachusetts General Hospital (MGH) Diabetes Center will be piloting this model with a multi-disciplinary team of diabetologists, nurse practitioners, diabetes nurse educators, and mental health provider. Patients scheduled to be seen in the diabetes collaborative care model will continue to follow in the diabetes collaborative care model, with follow up visits every 3-4 months. All patients will receive routine diabetes care with lab testing, medical interventions, therapies and referrals performed at the discretion of the patients' providers.

Intervention Type: OTHER

Usual Care Model

Patients enrolled in this arm will receive routine diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center, with lab testing, medical interventions, therapies and referrals performed at the discretion of the patients' providers. In the usual care model, behavioral/mental health and social work services are available on a referral basis and are not integrated into a patients' routine appointment. Screening and treatment of psychosocial determinants of diabetes management are at done at the discretion of the patients' provider. Frequency of follow up visits is at the discretion of the patients' provider.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Type 1 or type 2 diabetes mellitus
• Between ages 18 and 30 years
• Any duration of diabetes
• Must self-manage diabetes
• A new patients at the Massachusetts General Hospital (MGH) Diabetes Center at 50 Staniford Street as of September 1, 2021.
• 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

• Patients with gestational diabetes, diabetes during pregnancy, MODY, or other forms of diabetes
• Patients with type 2 diabetes who are on no medications (diet-controlled), or metformin only unless they are within one year of diabetes onset
• Patients with significant cognitive, physical, or mental disability requiring that their diabetes care be managed by another individual (i.e. parent, spouse, guardian, nurse, residential facility) more than 25% of the time
• Non-English speaking
• Patients who are pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Deborah Wexler, MD

Clinical Director MGH Diabetes Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah J Wexler, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2021P002431

Identifier Type: -

Identifier Source: org_study_id