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Collaborative Care Model for Diabetes

N/A
Waitlist Available
Led By Deborah J Wexler, MD, MSc
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type 1 or type 2 diabetes mellitus
Between ages 18 and 30 years
Must not have
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
Patients with gestational diabetes, diabetes during pregnancy, MODY, or other forms of diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare an innovative care model for young adults with diabetes to the usual care model at MGH Diabetes Center.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial compares different models of care rather than medications, there aren't direct side effects like you'd expect from drugs. However, changes in healthcare management could impact patient stress levels or satisfaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have diabetes (type 1 or type 2).
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I am between 18 and 30 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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Someone else manages my diabetes care most of the time due to my disability.
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I have had diabetes during pregnancy or another form of diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in diabetes-related distress, measured by Problem Areas in Diabetes (PAID)
Visit completion rate in patients seen in the collaborative care and usual care models
Secondary study objectives
Change in HbA1c
Change in Problem Areas in Diabetes (PAID) scores among those with score of 40 or higher at baseline, indicating moderate distress
Change in alcohol use, measured by Alcohol Use Disorders Identification Test Consumption (AUDIT-C)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Diabetes Collaborative Care Model for Young AdultsActive Control1 Intervention
Patients enrolled in this arm will receive diabetes care per the diabetes collaborative care model for young adults.
Group II: Usual Care ModelActive Control1 Intervention
Patients enrolled in this arm will receive diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,014 Previous Clinical Trials
13,309,386 Total Patients Enrolled
Deborah J Wexler, MD, MScPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
31 Total Patients Enrolled
~11 spots leftby Nov 2025
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