Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Getting diabetes support to see if it helps control blood sugar

Official title: Improving Diabetes Outcomes and Health Disparities by Addressing Unmet Resource Needs- A Sequential Multiple Assignment, Randomized Trial

Run by University of Michigan · NCT07676188 · Data updated 2026-11-12

This study tests different social and financial support tools to help adults with diabetes manage their condition and improve their health.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment694 (estimated)
SponsorUniversity of Michigan
Academic / other
Locations1 site (Ann Arbor, Michigan)
StatusRecruiting
StartedAugust 3, 2026
Main results expectedJanuary 31, 2030
Study endsJuly 31, 2030
Registry record updatedOctober 16, 2026
Trial IDNCT07676188 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 and older with Type 1 or Type 2 diabetes who have demonstrated financial or social needs and meet HbA1c criteria.

Probably not a fit

Participants without persistent social or financial challenges or those who do not respond to the supports may see limited or no improvement.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with diabetes who have unmet social or financial needs will be randomly assigned to one or more support interventions over a year, with surveys and health measurements (blood pressure and HbA1c) collected. The goal is to see which combination of supports works best to improve diabetes management and well-being. The study builds on prior work to identify adaptive sequences of supportive components that balance effectiveness with resource use. Results could guide how to optimize social and care resources for people with diabetes. The trial is led by the University of Michigan with NIDDK collaboration.

Why it matters

Potential benefit: If successful, participants and others with diabetes may experience better blood sugar control and reduced diabetes-related burdens through tailored social and financial support.

How similar studies have gone: Previous explorations show that social support and financial navigation can help with self-care, though effectiveness varies and adaptive approaches are still being refined.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Participants:

* Age: 18 years of age or older
* Diabetes diagnosis: Documented diagnosis of diabetes (Type 1 or Type 2) with prescribed anti-hyperglycemic medication
* Glycemic control: Most recent (within the past 6 months) recorded hemoglobin A1c (HbA1c) level of: ≥7.5% for individuals ≤70 years of age and ≥8.0% for individuals between 70-75 years of age Prior study participation: Did not participate in the CareAvenue trial (R01DK116715)
* Financial burden and/or social needs (meeting ONE or more of the following):

Positive report of financial burden using validated screening questions; Medicaid or dual Medicare/Medicaid coverage; Income ≤250% of the federal poverty level; Self-identified as ALICE (Asset-Limited, Income-Constrained, Employed): income above Medicaid threshold but reporting difficulty affording basic needs; Underinsured: high-deductible plan (≥$1,500 individual/$3,000 family) with self-reported difficulty affording healthcare costs; Positive screen for one or more social risk factors on PRAPARE or equivalent (food insecurity, housing instability, transportation barriers, utility insecurity);

* Financial decision-making: Self-identifies as primarily responsible for making own healthcare financial decisions (to address concerns about young adults dependent on family support).
* Interest in assistance: Expresses interest in receiving assistance with unmet social needs.
* Ability to participate: Able to complete the screening process in English (or Spanish/Arabic if materials available) on behalf of self.
* Healthcare access: Receives or is able to receive care at Michigan Medicine (required for potential social worker referral).

Peer Supporters:

* Age: 18 years of age or older
* Diabetes diagnosis: Self-reported diagnosis of diabetes (Type 1 or Type 2)
* Glycemic control: Within the past three years, have had at least one hemoglobin A1c (HbA1c) level of: ≥7.5% for individuals ≤70 years of age and ≥8.0% for individuals ≥71 years of age AND A1c levels \<7.5% for individuals ≤70 years of age and \<8.0% for individuals ≥71 years of age
* Experience navigating social or financial resources: Self-reported success in navigating financial assistance or social services resources
* Ability to participate: Able to provide peer support in English (option to additionally provide support in Spanish and/or Arabic); Able to complete training; Able to make calls every other week with assigned participants; Able to submit call logs; Able to complete a brief survey about experience throughout participation.
* Confidence in diabetes self-management: Self-reported confidence in ability to manage diabetes

Exclusion Criteria:

Participants:

* Serious psychiatric disorder: Active diagnosis of schizophrenia, active psychosis, or other serious mental illness that would impair ability to engage in intervention (as determined by medical record review)
* Cognitive impairment: Documented moderate to severe cognitive impairment that would prevent meaningful participation in study activities (as determined by medical record review)
* Active substance use: Current active illicit drug use that would interfere with study participation (as determined by medical record review)
* Pregnancy: Currently pregnant or planning pregnancy during the study period (due to expected A1c changes) (as determined by medical record review)
* Glucose-altering medications: Currently taking medications that alter glucose metabolism as a side effect rather than for diabetes management, including: Chronic oral corticosteroids (≥2 weeks continuous use); Antipsychotic medications known to affect glucose; Other medications affecting glucose when NOT prescribed for diabetes management Note: GLP-1 agonists, SGLT2 inhibitors, and other diabetes medications are NOT excluded, regardless of whether they are also used for weight management
* Limited life expectancy: Self-reported or documented comorbidity expected to limit life span to less than 3 years
* Concurrent diabetes study participation: Currently enrolled in another diabetes intervention study
* Institutionalized: Currently residing in a nursing home, assisted living facility, correctional facility, or another group setting that prevents them from participating on their own behalf

Peer Supporters:

* Cognitive impairment: Self-reported cognitive impairment that would prevent meaningful participation in study activities
* Participation Concerns or Barriers: Self-reported concerns that would prevent meaningful participation in study activities
* Limited life expectancy: Self-reported or documented comorbidity expected to limit life span to less than 3 years
* Institutionalized: Currently residing in a nursing home, assisted living facility, correctional facility, or another group setting that prevents them from participating on their own

Where it's running

  • University of Michigan
    Ann Arbor, Michigan, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.