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NCT07676188
Leveraging Interventions for Needs and Knowledge in Diabetes (LINKD)
Conditions: Diabetes
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 694
Sponsor: University of Michigan
Location: University of Michigan Ann Arbor Michigan
Summary
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.
Eligibility 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 12 months, have had at least one hemoglobin A1c (HbA1c) level of: ≥7.5% for individuals ≤70 years of age and ≥8.5% for individuals ≥71 years of age, but have since had at least one A1c (HbA1c) level, including their most recent test, of: \
Source: ClinicalTrials.gov (NCT07676188). StuddyBuddy aggregates publicly available trial information.