Type 1 DiabetesNCT05229718
Understanding and Optimizing Care for Young Adults With Type 1 and Type 2 Diabetes Mellitus Transitioning to Adult Care
A study testing Diabetes Collaborative Care Model for Young Adults in people with Type 1 Diabetes and Type 2 Diabetes, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Diabetes Collaborative Care Model for Young Adults
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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
- Being tested
- Diabetes Collaborative Care Model for Young Adults, Usual Care Model
- Keywords
- Young Adults, Emerging Adults, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Diabetes Collaborative Care Model for Young Adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12 months
Secondary outcomes (6)
Change in HbA1c
Change in hemoglobin A1c
Measured: 12 months
Change in mood, measured by Patient Health Questionnaire-8 (PHQ-8)
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.
Measured: 12 months
Change in anxiety, measured by Generalized Anxiety Disorder Scale-7(GAD-7)
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.
Measured: 12 months
Change in Problem Areas in Diabetes (PAID) scores among those with score of 40 or higher at baseline, indicating moderate distress
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.
Measured: 12 months
Change in disordered eating behavior, measured by Diabetes Eating Problem Survey- Revised (DEPS-R)
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.
Measured: 12 months
Change in alcohol use, measured by Alcohol Use Disorders Identification Test Consumption (AUDIT-C)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Oct 2021
- Primary completion30 Nov 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Wexler, MD, Massachusetts General Hospital
- Investigators
- Deborah J Wexler, MD, MSc, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229718
- Sponsor's protocol ID
- 2021P002431
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pilot and Feasibility study, no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Optimizing Care for Young Adults With Type 1 and Type 2 Diabetes Mellitus Transitioning to the Adult Diabetes Care Setting
- ClinicalTrials.gov ID
- NCT05229718
- Acronym / sponsor ID
- 2021P002431
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- Young Adults, Emerging Adults, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Model | Active comparator | Other: Usual Care ModelPatients enrolled in this arm will receive diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center. |
| Diabetes Collaborative Care Model for Young Adults | Active comparator | Other: Diabetes Collaborative Care Model for Young AdultsPatients enrolled in this arm will receive diabetes care per the diabetes collaborative care model for young adults. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Collaborative Care Model for Young AdultsWe 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. | Other | Diabetes Collaborative Care Model for Young Adults |
| Usual Care ModelPatients 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. | Other | Usual Care Model |
Primary outcome
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
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.
6 secondary outcomes
Change in HbA1c
Time frame: 12 months
Change in mood, measured by Patient Health Questionnaire-8 (PHQ-8)
Time frame: 12 months
Change in anxiety, measured by Generalized Anxiety Disorder Scale-7(GAD-7)
Time frame: 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
Change in disordered eating behavior, measured by Diabetes Eating Problem Survey- Revised (DEPS-R)
Time frame: 12 months
Change in alcohol use, measured by Alcohol Use Disorders Identification Test Consumption (AUDIT-C)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Diabetes Collaborative Care for Young Adults: A Formative, Mixed Methods Study of a Pragmatic, Multidisciplinary Care Model for Young Adults With Diabetes in an Adult CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No. Pilot and Feasibility study, no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah J Wexler, MD, MSc principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Collaborative Care Model for Young Adults in people with Type 1 Diabetes and Type 2 Diabetes, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visit completion rate in patients seen in the collaborative care and usual care models (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.