NCT05229718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

4.2 years

First QC Date

January 27, 2022

Last Update Submit

April 30, 2026

Conditions

Type 1 DiabetesType 2 Diabetes

Keywords

Young AdultsEmerging AdultsDiabetes

Outcome Measures

Primary Outcomes (2)

  • Visit completion rate in patients seen in the collaborative care and usual care models

    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)

    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 Outcomes (6)

  • Change in HbA1c

    12 months

  • Change in mood, measured by Patient Health Questionnaire-8 (PHQ-8)

    12 months

  • Change in anxiety, measured by Generalized Anxiety Disorder Scale-7(GAD-7)

    12 months

  • Change in Problem Areas in Diabetes (PAID) scores among those with score of 40 or higher at baseline, indicating moderate distress

    12 months

  • Change in disordered eating behavior, measured by Diabetes Eating Problem Survey- Revised (DEPS-R)

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Usual Care Model

ACTIVE COMPARATOR

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

Other: Usual Care Model

Diabetes Collaborative Care Model for Young Adults

ACTIVE COMPARATOR

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

Interventions

Diabetes Collaborative Care Model for Young AdultsOTHER

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.

Diabetes Collaborative Care Model for Young Adults
Usual Care ModelOTHER

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.

Usual Care Model

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Deborah J Wexler, MD, MSc

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director MGH Diabetes Center

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 8, 2022

Study Start

October 1, 2021

Primary Completion

November 30, 2025

Study Completion

March 30, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Pilot and Feasibility study, no plan to share IPD

Locations

US(1)