Type 1 DiabetesT1CARENCT07059806
T1CARE: A Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes
A study testing T1CARE in people with Type 1 Diabetes, run by Yale University at 2 sites in United States.
Trial summary
Randomized controlled trial with a wait list control arm. Participants will be randomized 2:1 to T1CARE or wait list usual care arm. Participants will be recruited from the Yale Adult and Pediatric Diabetes Centers. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- T1CARE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Sep 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 Diabetes
- fluent in Spanish or English who reside in the greater New Haven area
Who cannot join
- cognitive impairment and otherwise unable to give written informed consent about participating in this study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Yale Adult Diabetes Center
New Haven, Connecticut, 06520
- Recruiting
Yale Children's Diabetes Center
New Haven, Connecticut, 06520
About this study
Official title: T1CARE: A Randomized Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes
Randomized controlled trial with a wait list control arm. Participants will be randomized 2:1 to T1CARE or wait list usual care arm. Participants will be recruited from the Yale Adult and Pediatric Diabetes Centers. Patients assigned to T1CARE will receive support from a Community Health Navigator at Project Access-New Haven.
Read the detailed description
Primary Objective To determine whether the T1CARE intervention improves resolution of health-related social needs compared to usual care.
Secondary Objectives
- To assess the feasibility and acceptability of the T1CARE intervention.
- To evaluate the impact of T1CARE on patient-reported outcomes, including diabetes distress, illness intrusiveness, and quality of life.
- To examine preliminary effects on clinical outcomes, particularly changes in HbA1c.
- Conditions
- Type 1 Diabetes
- Being tested
- T1CARE
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T1CAREBehavioural
The intervention includes navigation by a Community Health Navigator (CHN), who will assess and help address patients' SDOH-related needs, coordinate care, and provide social support.
| Study group | Role | What they receive |
|---|---|---|
| T1CARE | Experimental | Patients who are randomized to the intervention arm will be contacted by the Community Health Navigator (CHN) from Project Access-New Haven (PA-NH) (PA-NH). The CHN will conduct an in-depth in-person intake interview to understand the patient's social and clinical need. Additional assessment will include access to insulin, diabetes technologies, and other supplies. The intake will be the basis for a personalized intervention that will respond to patient's unique needs. The initial interview will be audio-recorded to allow for qualitative data analysis. Outcomes will be measured at 6 months. Participants in the T1CARE group will have an option to join a social media platform in addition to receiving individualized support from the CHN. Receives: Behavioral: T1CARE |
| Standard Care | No intervention | Participants in the control group will be receive standard screening for SDOH and standard diabetes care at their respective clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with resolution of health-related social needs
Resolution of health-related social needs, assessed via adapted Accountable Health Communities (AHC) Model screening questions. Yes/No for resolution.
Measured: 6 months
Secondary outcomes (5)
Mean score Diabetes Distress Scale (T1-DDS)
The T1-DDS is a 28-item self-report instrument. Each item is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem." Total score range 1-6 with higher scores indicating more distress. Investigators will analyze between-group change of the within-group change.
Measured: 6 months
Mean score Illness intrusiveness rating scale (IIRS)
IIRS comprised of 13 items that ask patients to rate the degree to which their "illness and/or its treatment" interfere with life domains central to quality of life. Total score range 13 to 91, with higher scores indicating greater illness intrusiveness. Investigators will analyze between-group change of the within-group change.
Measured: 6 months
Mean score DAWN Impact of Diabetes Profile (DIDP) scale
Quality of life measured by the brief (7 item) DIDP scale (DAWN Impact of Diabetes Profile). Total score range 1-7 with higher scores indicating more negative impact. Investigators will analyze between-group change of the within-group change.
Measured: 6 months
Mean score Patient satisfaction survey
Patient satisfaction with the intervention will be assessed with 2 questions on a 5-point Likert scale that address whether they were satisfied and would recommend the approach used for their care (which could have been T1CARE or usual care alone) to other patients. Total score range 1-5, higher scores indicate more satisfaction.
Measured: 6 Months
Change in HbA1c
Change in HbA1c at baseline and 6 months. Investigators will analyze between-group change of the within-group change.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start5 Sep 2025
- Primary completion30 Sep 2027 (estimated)
- Study completionNov 2027 (estimated)
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 Yale UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will complete a standardized Social Determinants of Health (SDOH) screening.
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kasia Lipska, MD, MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059806
- Sponsor's protocol ID
- 2000040438
- Other IDs
- 1R01DK139558-01A1
- Acronym
- T1CARE
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Metadata associated with the datasets will be submitted to the NIDDK repository or Vivli.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T1CARE: A Randomized Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07059806
- Acronym / sponsor ID
- T1CARE / 2000040438
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 11 Jul 2025 (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.
Randomized controlled trial with a wait list control arm. Participants will be randomized 2:1 to T1CARE or wait list usual care arm. Participants will be recruited from the Yale Adult and Pediatric Diabetes Centers. Patients assigned to T1CARE will receive support from a Community Health Navigator at Project Access-New Haven.
Detailed description
Primary Objective To determine whether the T1CARE intervention improves resolution of health-related social needs compared to usual care.
Secondary Objectives
- To assess the feasibility and acceptability of the T1CARE intervention.
- To evaluate the impact of T1CARE on patient-reported outcomes, including diabetes distress, illness intrusiveness, and quality of life.
- To examine preliminary effects on clinical outcomes, particularly changes in HbA1c.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will complete a standardized Social Determinants of Health (SDOH) screening.
| Arm | Type | Receives |
|---|---|---|
| T1CARE | Experimental | Behavioral: T1CAREPatients who are randomized to the intervention arm will be contacted by the Community Health Navigator (CHN) from Project Access-New Haven (PA-NH) (PA-NH). The CHN will conduct an in-depth in-person intake interview to understand the patient's social and clinical need. Additional assessment will include access to insulin, diabetes technologies, and other supplies. The intake will be the basis for a personalized intervention that will respond to patient's unique needs. The initial interview will be audio-recorded to allow for qualitative data analysis. Outcomes will be measured at 6 months. Participants in the T1CARE group will have an option to join a social media platform in addition to receiving individualized support from the CHN. |
| Standard Care | No intervention | –Participants in the control group will be receive standard screening for SDOH and standard diabetes care at their respective clinics. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Type 1 Diabetes
- fluent in Spanish or English who reside in the greater New Haven area
Key exclusion criteria (1 listed)
- cognitive impairment and otherwise unable to give written informed consent about participating in this study
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 |
|---|---|---|
| T1CAREThe intervention includes navigation by a Community Health Navigator (CHN), who will assess and help address patients' SDOH-related needs, coordinate care, and provide social support. | Behavioural | T1CARE |
Primary outcome
Number of participants with resolution of health-related social needs
Time frame: 6 months
Resolution of health-related social needs, assessed via adapted Accountable Health Communities (AHC) Model screening questions. Yes/No for resolution.
5 secondary outcomes
Mean score Diabetes Distress Scale (T1-DDS)
Time frame: 6 months
Mean score Illness intrusiveness rating scale (IIRS)
Time frame: 6 months
Mean score DAWN Impact of Diabetes Profile (DIDP) scale
Time frame: 6 months
Mean score Patient satisfaction survey
Time frame: 6 Months
Change in HbA1c
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. Metadata associated with the datasets will be submitted to the NIDDK repository or Vivli.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Kasia Lipska, MD, MHS principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T1CARE in people with Type 1 Diabetes, run by Yale University at 2 sites 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kasia J Lipska, MD (203-500-3053, Kasia.lipska@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with resolution of health-related social needs (time frame: 6 months). 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 26 Oct 2026.