Diabetes Mellitus, Type 2NCT05472441
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
A study testing Mid-Ohio Food Farmacy, Mid-Ohio Food Farmacy + Cooking for Diabetes and Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub in people with Diabetes Mellitus, Type 2 and Nutrition Poor, run by Ohio State University at 1 site in United States.
Trial summary
This is a pragmatic randomized controlled trial (pRCT) that aims to test the effect of produce provision, diabetes education, and community referrals on hemoglobin A1c levels in individuals with type 2 diabetes experiencing food insecurity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Nutrition Poor, Food Deprivation
- What is being tested?
- Mid-Ohio Food Farmacy, Mid-Ohio Food Farmacy + Cooking for Diabetes and Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 568 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 31 Mar 2027
- 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
- Type 2 Diabetes based on American Diabetes Association Criteria
- Hemoglobin A1c ≥ 7.5%
- Screen Positive on 2-item Food Security Screener
Who cannot join
- Unwilling to Attest to Release of Information to Mid-Ohio Food Collective
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
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Ashley Mintos, BS, CCRC, (614) 366-5504, Ashley.Mintos@osumc.edu
Joshua J Joseph, MD
About this study
This is a pragmatic randomized controlled trial (pRCT) that aims to test the effect of produce provision, diabetes education, and community referrals on hemoglobin A1c levels in individuals with type 2 diabetes experiencing food insecurity.
Read the detailed description
LINK (Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care is a 6-month pragmatic randomized controlled trial (pRCT) using a 2x2 factorial design to prospectively enroll study participants with type 2 diabetes and food insecurity into one of four study arms. The four study arms are: 1) Mid-Ohio Farmacy (receiving weekly produce through a consortium of local food banks); 2) Mid-Ohio Farmacy + Cooking for Diabetes (Cooking for Diabetes is a 6-week diabetes and culinary education intervention); 3) Mid-Ohio Farmacy + Health Impact Ohio Pathways Hub (The Pathways Hub uses a community health worker model to meet with participants, evaluate and address non-medical, health-related social needs); and 4) Mid-Ohio Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub). Participants will be enter
Participants will be randomized using a 1:1:1:1 stratified randomization scheme built into Research Electronic Data Capture (REDCap) at the participant level.
Primary and secondary outcomes will be collected at baseline, 3 and 6 months.
- Conditions
- Diabetes Mellitus, Type 2, Nutrition Poor, Food Deprivation
- Being tested
- Mid-Ohio Food Farmacy, Mid-Ohio Food Farmacy + Cooking for Diabetes, Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub, Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub
- Keywords
- Food Insecurity, Social Determinants of Health, Non-medical, health related social needs, Diabetes Self-Management Education and Support
- Medical subject headings
- Diabetes Mellitus, Type 2, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mid-Ohio Food FarmacyBehavioural
The Food Farmacy arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective.
Mid-Ohio Food Farmacy + Cooking for DiabetesBehavioural
The Food Farmacy + Cooking for Diabetes Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention.
Mid-Ohio Food Farmacy + Health Impact Ohio Pathways HubBehavioural
The Food Farmacy + Health Impact Ohio Pathways Hub Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and has social needs address through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs.
Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways HubBehavioural
The Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub Arm receives all 3 interventions. Participants receive weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective, Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention and has social needs addressed through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs.
| Study group | Role | What they receive |
|---|---|---|
| Mid Ohio Food Farmacy | Active comparator | The Food Farmacy arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective. Receives: Behavioral: Mid-Ohio Food Farmacy |
| Mid-Ohio Food Farmacy + Cooking for Diabetes | Experimental | The Food Farmacy + Cooking for Diabetes Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention. Receives: Behavioral: Mid-Ohio Food Farmacy + Cooking for Diabetes |
| Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub | Experimental | The Food Farmacy + Health Impact Ohio Pathways Hub Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and has social needs address through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs. Receives: Behavioral: Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub |
| Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub | Experimental | The Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub Arm receives all 3 interventions. Participants receive weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective, Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention and has social needs addressed through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs. Receives: Behavioral: Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c
measures average blood sugar levels over the past 3 months
Measured: 3 months
Secondary outcomes (5)
Change in Hemoglobin A1c
measures average blood sugar levels over the past 3 months
Measured: 6 months
Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale
Diabetes self-efficacy measured via the diabetes self-efficacy scale. The Diabetes Self-Efficacy Scale has a minimum score of 10 and a maximum score of 80. A higher score indicates higher diabetes self-efficacy.
Measured: 3 months
Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale
Diabetes self-efficacy measured via the diabetes self-efficacy scale. The Diabetes Self-Efficacy Scale has a minimum score of 10 and a maximum score of 80. A higher score indicates higher diabetes self-efficacy.
Measured: 6 months
Change in food security assessed using the 18-item U.S. Household Food Security Survey Module
Food security will be assessed using the 18-item U.S. Household Food Security Survey Module.
For households with one or more children:
- Raw score zero-High food security
- Raw score 1-2-Marginal food security
- Raw score 3-7-Low food security
- Raw score 8-18-Very low food security
For households with no child present:
- Raw score zero-High food security
- Raw score 1-2-Marginal food security
- Raw score 3-5-Low food security
- Raw score 6-10-Very low food security
Measured: 3 months
Change in food security assessed using the 18-item U.S. Household Food Security Survey Module
Food security will be assessed using the 18-item U.S. Household Food Security Survey Module.
For households with one or more children:
- Raw score zero-High food security
- Raw score 1-2-Marginal food security
- Raw score 3-7-Low food security
- Raw score 8-18-Very low food security
For households with no child present:
- Raw score zero-High food security
- Raw score 1-2-Marginal food security
- Raw score 3-5-Low food security
- Raw score 6-10-Very low food security
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start6 Feb 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The LINK pragmatic randomized controlled trial (pRCT) uses a 2x2 factorial design to prospectively enroll study participants with type 2 diabetes and food insecurity into one of four study arms. The four study arms are: 1) Mid-Ohio Farmacy (receiving weekly produce through a consortium of local food banks); 2) Mid-Ohio Farmacy + Cooking for Diabetes (Cooking for Diabetes is a 6-week diabetes and culinary education intervention); 3) Mid-Ohio Farmacy + Health Impact Ohio Pathways Hub (The Pathways Hub uses a community health worker model to meet with participants, evaluate and address non-medical, health-related social needs); and 4) Mid-Ohio Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub). Participants will be randomized using a 1:1:1:1 stratified randomization scheme built into Research Electronic Data Capture (REDCap) at the participant level.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 568 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Joseph, MD, Ohio State University
- Investigators
- Joshua Joseph, MD, MPH, Principal investigator, Ohio State UniversityDaniel Walker, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472441
- Sponsor's protocol ID
- 2022H0045
- Other IDs
- R01DK132403
- Status last verified
- Nov 2026
- First submitted
- 21 Jul 2022
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available to the public as immediately and broadly as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. All research data will be shared as requested in accordance with federal regulations, the Freedom of Information Act (FOIA). Requests from researchers will be reviewed by the project investigators, and we will provide the requesting researcher with the minimum necessary data; the shared data will not have any individual participant identifiers or specific clinic identifiers.
Publications
Gilmore D, Bunger A, Garrity K, Bose-Brill S, Scheck McAlearney A, Hefner JL, Seiber E, Garner JA, Headings A, Joseph JJ, Walker DM. Defining the Social Needs Service Cascade: Evidence From A Multistakeholder Qualitative Study. Med Care Res Rev. 2026 Apr 29:10775587261439173. doi: 10.1177/10775587261439173. Online ahead of print.
PubMed 42052990Walker DM, Garner JA, Hefner JL, Headings A, Jonas DE, Clark A, Bose-Brill S, Nawaz S, Seiber E, McAlearney AS, Brock G, Zhao S, Reopell L, Coovert N, Shrodes JC, Spees CK, Sieck CJ, Di Tosto G, DePuccio MJ, Williams A, Hoseus J, Baker C, Brown MM, Joseph JJ. Rationale and design of the linking education, produce provision, and community referrals to improve diabetes care (LINK) study. Contemp Clin Trials. 2023 Jul;130:107212. doi: 10.1016/j.cct.2023.107212. Epub 2023 Apr 28.
PubMed 37121390
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
- ClinicalTrials.gov ID
- NCT05472441
- Acronym / sponsor ID
- 2022H0045
- Conditions
- Diabetes Mellitus, Type 2, Nutrition Poor, Food Deprivation
- Keywords
- Food Insecurity, Social Determinants of Health, Non-medical, health related social needs, Diabetes Self-Management Education and Support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 568 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 25 Jul 2022 (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.
This is a pragmatic randomized controlled trial (pRCT) that aims to test the effect of produce provision, diabetes education, and community referrals on hemoglobin A1c levels in individuals with type 2 diabetes experiencing food insecurity.
Detailed description
LINK (Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care is a 6-month pragmatic randomized controlled trial (pRCT) using a 2x2 factorial design to prospectively enroll study participants with type 2 diabetes and food insecurity into one of four study arms. The four study arms are: 1) Mid-Ohio Farmacy (receiving weekly produce through a consortium of local food banks); 2) Mid-Ohio Farmacy + Cooking for Diabetes (Cooking for Diabetes is a 6-week diabetes and culinary education intervention); 3) Mid-Ohio Farmacy + Health Impact Ohio Pathways Hub (The Pathways Hub uses a community health worker model to meet with participants, evaluate and address non-medical, health-related social needs); and 4) Mid-Ohio Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub). Participants will be enter
Participants will be randomized using a 1:1:1:1 stratified randomization scheme built into Research Electronic Data Capture (REDCap) at the participant level.
Primary and secondary outcomes will be collected at baseline, 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The LINK pragmatic randomized controlled trial (pRCT) uses a 2x2 factorial design to prospectively enroll study participants with type 2 diabetes and food insecurity into one of four study arms. The four study arms are: 1) Mid-Ohio Farmacy (receiving weekly produce through a consortium of local food banks); 2) Mid-Ohio Farmacy + Cooking for Diabetes (Cooking for Diabetes is a 6-week diabetes and culinary education intervention); 3) Mid-Ohio Farmacy + Health Impact Ohio Pathways Hub (The Pathways Hub uses a community health worker model to meet with participants, evaluate and address non-medical, health-related social needs); and 4) Mid-Ohio Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub). Participants will be randomized using a 1:1:1:1 stratified randomization scheme built into Research Electronic Data Capture (REDCap) at the participant level.
| Arm | Type | Receives |
|---|---|---|
| Mid Ohio Food Farmacy | Active comparator | Behavioral: Mid-Ohio Food FarmacyThe Food Farmacy arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective. |
| Mid-Ohio Food Farmacy + Cooking for Diabetes | Experimental | Behavioral: Mid-Ohio Food Farmacy + Cooking for DiabetesThe Food Farmacy + Cooking for Diabetes Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention. |
| Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub | Experimental | Behavioral: Mid-Ohio Food Farmacy + Health Impact Ohio Pathways HubThe Food Farmacy + Health Impact Ohio Pathways Hub Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and has social needs address through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs. |
| Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub | Experimental | Behavioral: Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways HubThe Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub Arm receives all 3 interventions. Participants receive weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective, Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention and has social needs addressed through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 Diabetes based on American Diabetes Association Criteria
- Hemoglobin A1c ≥ 7.5%
- Screen Positive on 2-item Food Security Screener
Key exclusion criteria (1 listed)
- Unwilling to Attest to Release of Information to Mid-Ohio Food Collective
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 |
|---|---|---|
| Mid-Ohio Food FarmacyThe Food Farmacy arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective. | Behavioural | Mid Ohio Food Farmacy |
| Mid-Ohio Food Farmacy + Cooking for DiabetesThe Food Farmacy + Cooking for Diabetes Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention. | Behavioural | Mid-Ohio Food Farmacy + Cooking for Diabetes |
| Mid-Ohio Food Farmacy + Health Impact Ohio Pathways HubThe Food Farmacy + Health Impact Ohio Pathways Hub Arm receives weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective and has social needs address through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs. | Behavioural | Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub |
| Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways HubThe Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub Arm receives all 3 interventions. Participants receive weekly produce through a consortium of local food banks at the direction of the Mid-Ohio Food Collective, Cooking for Diabetes, a 6-week diabetes self-management education and support and culinary education intervention and has social needs addressed through a community health worker model at the direction of Health Impact Ohio. The community health worker meets with participants, evaluates and addresses non-medical, health-related social needs. | Behavioural | Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub |
Primary outcome
Change in Hemoglobin A1c
Time frame: 3 months
measures average blood sugar levels over the past 3 months
5 secondary outcomes
Change in Hemoglobin A1c
Time frame: 6 months
Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale
Time frame: 3 months
Change in diabetes self-efficacy assessed by the Diabetes Self-Efficacy Scale
Time frame: 6 months
Change in food security assessed using the 18-item U.S. Household Food Security Survey Module
Time frame: 3 months
Change in food security assessed using the 18-item U.S. Household Food Security Survey Module
Time frame: 6 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 5 Nov 2026.
- Derived from this study: PubMed 42052990Gilmore D, Bunger A, Garrity K, Bose-Brill S, Scheck McAlearney A, Hefner JL, Seiber E, Garner JA, Headings A, Joseph JJ, Walker DM. Defining the Social Needs Service Cascade: Evidence From A Multistakeholder Qualitative Study. Med Care Res Rev. 2026 Apr 29:10775587261439173. doi: 10.1177/10775587261439173. Online ahead of print.
- Derived from this study: PubMed 37121390Walker DM, Garner JA, Hefner JL, Headings A, Jonas DE, Clark A, Bose-Brill S, Nawaz S, Seiber E, McAlearney AS, Brock G, Zhao S, Reopell L, Coovert N, Shrodes JC, Spees CK, Sieck CJ, Di Tosto G, DePuccio MJ, Williams A, Hoseus J, Baker C, Brown MM, Joseph JJ. Rationale and design of the linking education, produce provision, and community referrals to improve diabetes care (LINK) study. Contemp Clin Trials. 2023 Jul;130:107212. doi: 10.1016/j.cct.2023.107212. Epub 2023 Apr 28.
- Individual participant dataSharing planned: Yes. Data will be made available to the public as immediately and broadly as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. All research data will be shared as requested in accordance with federal regulations, the Freedom of Information Act (FOIA). Requests from researchers will be reviewed by the project investigators, and we will provide the requesting researcher with the minimum necessary data; the shared data will not have any individual participant identifiers or specific clinic identifiers.
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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.
Joshua Joseph, MD, MPH principal investigator
Ohio State University
Daniel Walker, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mid-Ohio Food Farmacy, Mid-Ohio Food Farmacy + Cooking for Diabetes and Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub in people with Diabetes Mellitus, Type 2 and Nutrition Poor, run by Ohio State University 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 3 inclusion and 1 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 5 Nov 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 Luiza Reopell, BS (614-653-8213, luiza.reopell@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05472441, which also lists 2 linked publications.
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 5 Nov 2026.