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

Mass General Brigham

Status: Active, not recruiting

Conditions: Type 1 Diabetes; Type 2 Diabetes

Treatments: Other: Usual Care Model; Other: Diabetes Collaborative Care Model for Young Adults

Study type: Interventional

Funder types: Other

Identifiers

NCT05229718

2021P002431

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Usual Care Model

Active Comparator group

Description:

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

Treatment:

Other: Usual Care Model

Diabetes Collaborative Care Model for Young Adults

Active Comparator group

Description:

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

Treatment:

Other: Diabetes Collaborative Care Model for Young Adults