Leveraging Interventions for Needs and Knowledge in Diabetes (LINKD)

Recruiting now · Not applicable

Conditions studied: Diabetes

In brief

Unmet social needs and economic burden persist as key reasons why one-third of people with diabetes have poor disease control. The purpose of this study is to learn whether different tools and types of support may help people manage diabetes and related challenges. The study will compare several approaches to understand how they affect people's experiences and health over time. Completion of the study aims will lead to an optimized intervention to improve the health and social well-being of people with diabetes. Participants will be randomly assigned to one or more interventions aimed at addressing social and financial needs and will complete multiple surveys over the course of a year. The study team will collect information about their blood pressure and HbA1c (blood glucose). Findings will advance the field by determining the effectiveness of supportive interventions to address both social needs and diabetes self-care, and by informing protocols for the optimal sequencing of these strategies, a critical evidence gap in healthcare settings.

Key facts

Study ID: NCT07676188
Run by: University of Michigan
People needed: 694
Starts: 2026-08-03
Expected to finish: 2030-07-31
Last updated by the study team: 2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 12 months, 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

You may not qualify if…

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 is running

University of Michigan — Ann Arbor, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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