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

April 30, 2026 updated by: Deborah Wexler, MD, Massachusetts General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care Model
Patients enrolled in this arm will receive diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center.
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.
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visit completion rate in patients seen in the collaborative care and usual care models
Time Frame: 12 months
Mean number of completed visits compared to scheduled visits (visit completion rate) in patients seen in the collaborative care and usual care models
12 months
Change in diabetes-related distress, measured by Problem Areas in Diabetes (PAID)
Time Frame: 12 months
Problems Areas in Diabetes (PAID) is a validated screening tool for diabetes-related distress. Will measure change in PAID scores for both arms. The minimum score is 0 and maximum score is 80. The higher the score, the more severe diabetes-related distress.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: 12 months
Change in hemoglobin A1c
12 months
Change in mood, measured by Patient Health Questionnaire-8 (PHQ-8)
Time Frame: 12 months
Patient Health Questionnaire-8 (PHQ-8) is a validated screening tool for depression. The minimum score is 0 and maximum score is 24. The higher the score, the more severe depression.
12 months
Change in anxiety, measured by Generalized Anxiety Disorder Scale-7(GAD-7)
Time Frame: 12 months
Generalized Anxiety Disorder Scale-7(GAD-7) is a validated screening tool for anxiety. The minimum score is 0 and maximum score is 21. The higher the score, the more severe anxiety.
12 months
Change in Problem Areas in Diabetes (PAID) scores among those with score of 40 or higher at baseline, indicating moderate distress
Time Frame: 12 months
Problems Areas in Diabetes (PAID) is a validated screening tool for diabetes-related distress. Will measure change in PAID scores for both arms. The minimum score is 0 and maximum score is 80. The higher the score, the more severe diabetes-related distress.
12 months
Change in disordered eating behavior, measured by Diabetes Eating Problem Survey- Revised (DEPS-R)
Time Frame: 12 months
Diabetes Eating Problem Survey- Revised (DEPS-R) is a validated screening tool for disordered eating behavior for patients with diabetes on insulin therapy. The minimum score is 0 and maximum score is 75. The higher the score, the most severe disordered eating behavior.
12 months
Change in alcohol use, measured by Alcohol Use Disorders Identification Test Consumption (AUDIT-C)
Time Frame: 12 months
Alcohol Use Disorders Identification Test Consumption (AUDIT-C) is a three-item self-administered screening test for alcohol misuse, validated in adults 18 years and older.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Deborah J Wexler, MD, MSc, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

November 30, 2025

Study Completion (Actual)

March 30, 2026

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021P002431

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pilot and Feasibility study, no plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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