DiabetesLINKDNCT07676188
Leveraging Interventions for Needs and Knowledge in Diabetes
A study testing FindHelp, Peer Support and Social Work in people with Diabetes, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- FindHelp, Peer Support and Social Work
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 694 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2026to 31 Jul 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Minal R Patel, 734-763-0087, minalrp@umich.edu
About this study
Official title: Improving Diabetes Outcomes and Health Disparities by Addressing Unmet Resource Needs- A Sequential Multiple Assignment, Randomized Trial
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.
Read the detailed description
Multiple adverse social risks (e.g. food and/or housing insecurity, transportation challenges, social isolation) and out-of-pocket, disease-related expenses are key reasons 1/3 of people with diabetes have high A1cs. Through the CareAvenue mHealth intervention (R01DK116715), the investigators enhanced the original intervention of screening for social risks and connecting people with diabetes to resources by adding features for observational learning, autonomy support, action planning, and self-monitoring. The investigators observed low engagement with the intervention and effectiveness for only 5% of participants. Social support interventions (e.g. peer support, financial navigators, social workers) are more effective in addressing unmet social needs and self- care challenges than stand-alone technology tools. However, these strategies are more resource- and labor- intensive. Rather than dispensing the same fixed package of treatment components to all patients, an adaptive approach can conserve resources by initiating autonomy-supportive treatment, and stepping up treatments for those with suboptimal uptake. This R01 builds on the productivity, infrastructure, and investment of their prior work to address key knowledge gaps for uptake of social care assistance to improve disease outcomes.
The overarching goal of this study is to identify what type of supportive components are optimal for addressing unmet social needs and diabetes self-care, and which of five adaptive sequences of treatment results in better outcomes. The investigators will recruit 594 people with diabetes who have high A1cs, unmet social needs, and want assistance with their needs. They will use a Sequential Multiple Assignment Randomized Trial (SMART) design with 12-month follow-up to conduct this research. In Aim 1, they will determine which of five adaptive intervention sequences is optimal for reducing A1c compared to social needs app only (usual care): 1) App + peer support; 2) App + social worker; 3) App + technology-supported financial navigation; 4) App + peer support + social worker; 5) App + peer support + technology-supported financial navigation. In Aim 2, they will determine which of two augmented treatment adaptations is optimal for reducing A1c among non-responders: social worker or technology-supported financial navigation. In exploratory Aim 2A, they will identify patient-level moderators of treatment effect to inform personalized, resource-efficient protocols. In Aim 3, they will estimate the cost-effectiveness of five adaptive intervention sequences.
The result of this SMART study will be an optimized, adaptive intervention to improve the health and social well-being of people with diabetes by determining the most effective intervention strategies.
- Conditions
- Diabetes
- Being tested
- FindHelp, Peer Support, Social Work, Financial Navigation
- Keywords
- Diabetes, Intervention Strategies, Social Support, Financial Support, Disease Management
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FindHelpBehavioural
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.
Peer SupportBehavioural
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.
Social WorkBehavioural
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.
Financial NavigationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| FindHelp | Experimental | Not described Receives: Behavioral: FindHelp |
| FindHelp with Social Worker | Experimental | Not described Receives: Behavioral: FindHelp; Behavioral: Social Work |
| FindHelp with Financial Navigation | Experimental | Not described Receives: Behavioral: FindHelp; Behavioral: Financial Navigation |
| FindHelp + Peer Support | Experimental | Not described Receives: Behavioral: FindHelp; Behavioral: Peer Support |
| FindHelp + Peer Support with Social Worker | Experimental | Not described Receives: Behavioral: FindHelp; Behavioral: Peer Support; Behavioral: Social Work |
| FindHelp + Peer Support w/ Financial Navigation | Experimental | Not described Receives: Behavioral: FindHelp; Behavioral: Peer Support; Behavioral: Financial Navigation |
| Peer Supporters | Other | Up to 100 peer supporters will be recruited, matched, and provide ongoing support to 1-4 study participants. Receives: Behavioral: Peer Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
This clinical marker of diabetes control will be measured via laboratory tests (blood draw)
Measured: 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
Measured: Readings will be taken at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
Secondary outcomes (5)
Diabetes self-care behaviors
Survey will utilize questions adapted from the Diabetes Self-Management Questionnaire - Revised (DSMQ-R)
Measured: This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
Uptake of social care assistance
Survey items assessing intervention utilization and resource uptake
Measured: This outcome will be assessed at 3 assessment points: At 3-months, 6-months, and 12-months
Successfully addressing social/financial need
Survey items will assess the extent to which participants social and/or financial needs are being addressed
Measured: This outcome will be assessed at 3 assessment points: At 3-months, 6-months, and 12-months
Treatment-related financial stress
Survey will utilize the COST-FACIT scale (de Souza et al., 2017), adapted for diabetes
Measured: This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
Cost-related non-adherence behaviors
Survey questions adapted from Medicare Current Beneficiary Survey (MCBS) \& National Health Interview Survey (NHIS)
Measured: This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start3 Aug 2026
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART) design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 694 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minal Patel, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676188
- Sponsor's protocol ID
- HUM00284695
- Other IDs
- 1R01DK142645-01A1
- Acronym
- LINKD
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diabetes Outcomes and Health Disparities by Addressing Unmet Resource Needs- A Sequential Multiple Assignment, Randomized Trial
- ClinicalTrials.gov ID
- NCT07676188
- Acronym / sponsor ID
- LINKD / HUM00284695
- Conditions
- Diabetes
- Keywords
- Diabetes, Intervention Strategies, Social Support, Financial Support, Disease Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 694 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 30 Jun 2026 (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.
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.
Detailed description
Multiple adverse social risks (e.g. food and/or housing insecurity, transportation challenges, social isolation) and out-of-pocket, disease-related expenses are key reasons 1/3 of people with diabetes have high A1cs. Through the CareAvenue mHealth intervention (R01DK116715), the investigators enhanced the original intervention of screening for social risks and connecting people with diabetes to resources by adding features for observational learning, autonomy support, action planning, and self-monitoring. The investigators observed low engagement with the intervention and effectiveness for only 5% of participants. Social support interventions (e.g. peer support, financial navigators, social workers) are more effective in addressing unmet social needs and self- care challenges than stand-alone technology tools. However, these strategies are more resource- and labor- intensive. Rather than dispensing the same fixed package of treatment components to all patients, an adaptive approach can conserve resources by initiating autonomy-supportive treatment, and stepping up treatments for those with suboptimal uptake. This R01 builds on the productivity, infrastructure, and investment of their prior work to address key knowledge gaps for uptake of social care assistance to improve disease outcomes.
The overarching goal of this study is to identify what type of supportive components are optimal for addressing unmet social needs and diabetes self-care, and which of five adaptive sequences of treatment results in better outcomes. The investigators will recruit 594 people with diabetes who have high A1cs, unmet social needs, and want assistance with their needs. They will use a Sequential Multiple Assignment Randomized Trial (SMART) design with 12-month follow-up to conduct this research. In Aim 1, they will determine which of five adaptive intervention sequences is optimal for reducing A1c compared to social needs app only (usual care): 1) App + peer support; 2) App + social worker; 3) App + technology-supported financial navigation; 4) App + peer support + social worker; 5) App + peer support + technology-supported financial navigation. In Aim 2, they will determine which of two augmented treatment adaptations is optimal for reducing A1c among non-responders: social worker or technology-supported financial navigation. In exploratory Aim 2A, they will identify patient-level moderators of treatment effect to inform personalized, resource-efficient protocols. In Aim 3, they will estimate the cost-effectiveness of five adaptive intervention sequences.
The result of this SMART study will be an optimized, adaptive intervention to improve the health and social well-being of people with diabetes by determining the most effective intervention strategies.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART) design
| Arm | Type | Receives |
|---|---|---|
| FindHelp | Experimental | Behavioral: FindHelp |
| FindHelp with Social Worker | Experimental | Behavioral: FindHelp, Behavioral: Social Work |
| FindHelp with Financial Navigation | Experimental | Behavioral: FindHelp, Behavioral: Financial Navigation |
| FindHelp + Peer Support | Experimental | Behavioral: FindHelp, Behavioral: Peer Support |
| FindHelp + Peer Support with Social Worker | Experimental | Behavioral: FindHelp, Behavioral: Peer Support, Behavioral: Social Work |
| FindHelp + Peer Support w/ Financial Navigation | Experimental | Behavioral: FindHelp, Behavioral: Peer Support, Behavioral: Financial Navigation |
| Peer Supporters | Other | Behavioral: Peer SupportUp to 100 peer supporters will be recruited, matched, and provide ongoing support to 1-4 study participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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);
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| FindHelpAll 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. | Behavioural | FindHelp, FindHelp + Peer Support, FindHelp + Peer Support w/ Financial Navigation, FindHelp + Peer Support with Social Worker, FindHelp with Financial Navigation, FindHelp with Social Worker |
| Peer SupportSome 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. | Behavioural | FindHelp + Peer Support, FindHelp + Peer Support w/ Financial Navigation, FindHelp + Peer Support with Social Worker, Peer Supporters |
| Social WorkParticipants 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. | Behavioural | FindHelp + Peer Support with Social Worker, FindHelp with Social Worker |
| Financial NavigationParticipants 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. | Behavioural | FindHelp + Peer Support w/ Financial Navigation, FindHelp with Financial Navigation |
Primary outcome
HbA1c
Time frame: Labs will be drawn at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
This clinical marker of diabetes control will be measured via laboratory tests (blood draw)
Blood Pressure
Time frame: Readings will be taken at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
All participants will receive an at-home Omron blood pressure monitor and will take two readings during each assessment
5 secondary outcomes
Diabetes self-care behaviors
Time frame: This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
Uptake of social care assistance
Time frame: This outcome will be assessed at 3 assessment points: At 3-months, 6-months, and 12-months
Successfully addressing social/financial need
Time frame: This outcome will be assessed at 3 assessment points: At 3-months, 6-months, and 12-months
Treatment-related financial stress
Time frame: This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
Cost-related non-adherence behaviors
Time frame: This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-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 16 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FindHelp, Peer Support and Social Work in people with Diabetes, run by University of Michigan at 1 site 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 17 inclusion and 14 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 16 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 1 site 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 Minal R Patel (734-763-0087, minalrp@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Labs will be drawn at 4 assessment points: At baseline, 3-months, 6-months, and 12-months). The study lists 2 primary outcomes in all. 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 16 Oct 2026.