Leveraging Interventions for Needs and Knowledge in Diabetes (LINKD)
LINKD
Improving Diabetes Outcomes and Health Disparities by Addressing Unmet Resource Needs- A Sequential Multiple Assignment, Randomized Trial
2 other identifiers
interventional
694
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Jul 2026
Longer than P75 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2026
CompletedFirst Posted
Study publicly available on registry
June 30, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2030
July 20, 2026
July 1, 2026
3.6 years
June 23, 2026
July 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
HbA1c
This clinical marker of diabetes control will be measured via laboratory tests (blood draw)
Labs will be drawn at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
Blood Pressure
All participants will receive an at-home Omron blood pressure monitor and will take two readings during each assessment
Readings will be taken at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
Secondary Outcomes (5)
Diabetes self-care behaviors
This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
Uptake of social care assistance
This outcome will be assessed at 3 assessment points: At 3-months, 6-months, and 12-months
Successfully addressing social/financial need
This outcome will be assessed at 3 assessment points: At 3-months, 6-months, and 12-months
Treatment-related financial stress
This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
Cost-related non-adherence behaviors
This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
Study Arms (7)
FindHelp
EXPERIMENTALFindHelp with Social Worker
EXPERIMENTALFindHelp with Financial Navigation
EXPERIMENTALFindHelp + Peer Support
EXPERIMENTALFindHelp + Peer Support with Social Worker
EXPERIMENTALFindHelp + Peer Support w/ Financial Navigation
EXPERIMENTALPeer Supporters
OTHERUp to 100 peer supporters will be recruited, matched, and provide ongoing support to 1-4 study participants.
Interventions
All study participants will be assigned to engage FindHelp (www.FindHelp.org), either as a stand-alone intervention (usual care) or in combination with Peer Support and/or second-stage interventions, as applicable. FindHelp is a free website/app that connects people to local resources.
Some participants will be assigned to receive the peer support intervention, which will involve pairing participants with a peer supporter whose experience with diabetes management may help them better manage their own condition. Peer supporters will be matched with participants based on shared demographic characteristics, diabetes type, and language. Peer supporters will be trained in key peer support skills, including motivational interviewing, to help participants explore and work toward their goals.
Participants will be referred to social workers within our health system, specifically with the Guest Assistance Program through Michigan Medicine. GAP connects patients with social workers knowledgeable about community and University of Michigan resources to work with them and problem-solve concerns affecting their health.
Participants will connect with the Patient Advocate Foundation's Case Management Program. PAF Case Management is a national program that provides free one-on-one support to eligible patients dealing with challenges related to a chronic health condition. Their case managers help people work through real-life issues, including access to medical treatment, understanding health insurance coverage, and applying for programs that may help with living expenses.
Eligibility Criteria
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
- +2 more criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 23, 2026
First Posted
June 30, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
January 31, 2030
Study Completion (Estimated)
July 31, 2030
Last Updated
July 20, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data access will be available for at least 10 years (anticipated between July 2030 and July 2040) or for as long as the repository exists.
- Access Criteria
- To safeguard privacy right of participants, the PI and corresponding staff will assure that all potentially identifying data fields are anonymized prior to release. All consent forms will include an extensive statement regarding data privacy and steps to protect data. Underlying Primary Data that are free of identifiers but contain sensitive information are immediately released with no fee for access but are deposited in controlled access repositories after receipt of a written request to the PI.
All de-identified clinical data will be made available upon request. Protocols and details on instrument settings, data transformation, and analysis will be available in the accompanying plain-text README. A data dictionary will be provided for the clinical dataset, defining units of measurement as necessary to understand and reuse it. Underlying Primary Data that is de-identified will be made broadly available through an appropriate data repository, in compliance with extant data use agreements. When permitted by data use agreements with our partnering agencies, underlying primary data will be shared simultaneously with Publication and made immediately accessible through release under the Creative Commons Attribution 4.0 Generic License or an equivalent license, or otherwise dedicated to the public domain. Study protocols, survey instruments, codebooks, and consent forms will be made available to facilitate the interpretation of the scientific data.