Diabetes MellitusFNaPSNCT06619834

Financial Navigation and Peer Support to Improve Diabetes Outcomes

A study testing Financial Navigation and Peer Support and Financial Navigation Only in people with Diabetes Mellitus and Glucose Metabolism Disorders, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial pilot study is to test the feasibility, acceptability, and preliminary efficacy of a combined intervention strategy of 1) technology-supported financial navigation to address economic burden of disease and 2) peer support both to facilitate linkages to clinical care and community… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases
What is being tested?: Financial Navigation and Peer Support and Financial Navigation Only
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteUnited States
Study dates: 11 Feb 2025to 4 Feb 2026
Phase: Interventional
Are there results?: None posted in the registry

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants:
18-75 years of age
diagnosis of diabetes with prescribed anti-hyperglycemic medication
most recent (within the past 6 months) recorded hemoglobin A1c (HbA1c) level of ≥7.5% for individuals ≤70 years and \&amp;gt;8.0% for individuals between 70-75 years in age
positive report of financial burden or cost-related non-adherence (CRN) using screening questions developed and validated from prior work 20-22
be willing to provide personal health information in order to effectively participate in the intervention

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Peer Supporters:
International Classification of Diseases (ICD)-10 code for diabetes
In the past had A1cs\&#39; \&gt; 8.0% but whose most recent A1c in the prior 12 months is \&lt;8.0%.
Past experience with economic burden or unmet social risk factors
Adults 18-75 years

Who cannot join

Participants:
a diagnosis of a serious psychiatric disorder (e.g., schizophrenia)
active alcohol or illicit drug use
current pregnancy or planning pregnancy
taking a medication that alters glucose metabolism (e.g., oral steroids)
report a comorbidity expected to limit life span to \&amp;lt; 3 years

Show all 11Show fewer

Participation in another diabetes study, but the investigators will ask them if they would like to be peer supporters
Peer Supporters:
A diagnosis of a serious psychiatric disorder (e.g., schizophrenia)
Active alcohol or illicit drug use
Current pregnancy or planning pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Pilot Trial of Financial Navigation and Peer Support to Improve Diabetes Outcomes

To examine the feasibility and acceptability of technology-supported financial navigation and financial navigation with peer support
To examine trends in preliminary efficacy of technology-supported financial navigation and peer support versus financial navigation-alone on 1) A1c and blood pressure (primary outcomes), and 2) out-of-pocket costs, treatment-related financial stress, cost-related non-adherence behaviors, diabetes distress, diabetes self-care behaviors, and uptake of social care assistance (secondary outcomes).

The investigators will assess whether a combined intervention of technology-supported financial navigation and peer support will produce trends in superior diabetes and social care outcomes to financial navigation alone via a 2-arm randomized controlled trial.

Participants will

Complete 3 survey appointments at baseline, and 3 and 6 months. Each appointment will consist of a survey assessment, an HbA1C test, and two blood pressure readings over the phone.
Be randomized to either financial navigation only or financial navigation and peer support.

Conditions: Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
Being tested: Financial Navigation and Peer Support, Financial Navigation Only
Medical subject headings: Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Financial Navigation and Peer SupportBehavioural
A combined intervention of technology-supported financial navigation and peer support: A professional financial navigator from TailorMed will use the software to assist participants in exploring options to reduce their specific economic barriers to treatment and care, and non-medical social risks. Participants will also be matched with a Peer Supporter to help improve the participants\' diabetes self-management.
Financial Navigation OnlyBehavioural
A professional financial navigator from TailorMed will use the software to assist participants in exploring options to reduce their specific economic barriers to treatment and care, and non-medical social risks.

Study groups in NCT06619834
Study group	Role	What they receive
Financial Navigation only	Active comparator	Financial navigation using software called TailorMed only. The professional Financial Navigator is from the TailorMed team. Receives: Behavioral: Financial Navigation Only
Financial Navigation and Peer Support	Active comparator	Financial navigation using software called TailorMed combined with peer support. The professional Financial Navigator is from the TailorMed team. Peer Supporters will be trained community members recruited from Michigan Medicine. Receives: Behavioral: Financial Navigation and Peer Support

What is being measured

The primary outcome is the main question the study is designed to answer.

A1c
Collect A1c sample using A1c Now SelfCheck test kit
Measured: From enrollment to the end of participant study duration at 6 months
Blood Pressure
Measure participant blood pressure using the Omron home blood pressure monitor. Both systolic and diastolic blood pressure will be measured.
Measured: From enrollment to the end of participant study duration at 6 months

Secondary outcomes (9)

Uptake of social care assistance
Adapted from Your Current Life Situation (YCLS) and Health Leads Screening Tools
Measured: From enrollment to the end of participant study duration at 6 months
Successfully having social/financial need address
Enrollment data from TailorMed software
Measured: From enrollment to the end of participant study duration at 6 months
Cost-related non-adherence behaviors
Individual survey items adapted from National Health Interview Survey (NHIS)
Measured: From enrollment to the end of participant study duration at 6 months
Out-of-pocket costs
Data generated from TailorMed software
Measured: From enrollment to the end of participant study duration at 6 months
Diabetes-related social support
Diabetes Support Scale (DSS) Minimum value- Strongly Disagree, Maximum value- Strongly Agree Higher score mean a better outcome.
Measured: From enrollment to the end of participant study duration at 6 months
Diabetes self-care behaviors
Diabetes Self-care Activities Scale - Adapted Minimum value- 0 Days, Maximum value- 7 Days Higher scores mean a better outcome.
Measured: From enrollment to the end of participant study duration at 6 months
Social needs screening
Accountable Health Communities Health-Related Social Needs Screening Tool (Q15-17) and Item adapted from National Health Interview Survey (Q18)
Adapted from Accountable Health Communities Health-Related Social Needs Screening Tool, Health Leads Social Needs Screening Toolkit, \&amp; Kaiser Permanente Your Current Life Situation Questionnaire
Minimum value- Never True, Maximum value- Often True. Higher scores mean worse outcome.
Measured: From enrollment to the end of participant study duration at 6 months
Diabetes Distress
Diabetes Distress Scale (DDS2 version)
Minimum Value- Not a Problem, Maximum Value- Serious Problem Higher scores mean worse outcome.
Measured: From enrollment to the end of participant study duration at 6 months
Treatment-related financial stress
COmprehensive Score for financial Toxicity (COST)-Functional Assessment of Chronic Illness Therapy (FACIT) domains adapted for diabetes
The score includes reverse-coding 6-items, summing all items, multiplying sum by 11 and dividing the total by number of items answered. Lower scores indicate higher perceptions of financial burden. (Min value of 0, max value of 44)
Measured: From enrollment to the end of participant study duration at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Feb 20254 Feb 2026

First posted1 Oct 2024
Study start11 Feb 2025
Primary completion16 Jan 2026
Study completion4 Feb 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes MellitusStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06619834
Sponsor's protocol ID: HUM00243207
Acronym: FNaPS
Status last verified: Mar 2026
First submitted: 27 Sep 2024
Last updated: 5 Mar 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All of the individual participant data that underlie results in a publication, after de-identification.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Trial of Financial Navigation and Peer Support to Improve Diabetes Outcomes
ClinicalTrials.gov ID: NCT06619834
Acronym / sponsor ID: FNaPS / HUM00243207
Conditions: Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: 11 Feb 2025 (actual)
Primary completion: 16 Jan 2026 (actual)
Study completion: 4 Feb 2026 (actual)
First posted: 1 Oct 2024 (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.

To examine the feasibility and acceptability of technology-supported financial navigation and financial navigation with peer support
To examine trends in preliminary efficacy of technology-supported financial navigation and peer support versus financial navigation-alone on 1) A1c and blood pressure (primary outcomes), and 2) out-of-pocket costs, treatment-related financial stress, cost-related non-adherence behaviors, diabetes distress, diabetes self-care behaviors, and uptake of social care assistance (secondary outcomes).

Participants will

Complete 3 survey appointments at baseline, and 3 and 6 months. Each appointment will consist of a survey assessment, an HbA1C test, and two blood pressure readings over the phone.
Be randomized to either financial navigation only or financial navigation and peer support.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Financial Navigation only	Active comparator	Behavioral: Financial Navigation OnlyFinancial navigation using software called TailorMed only. The professional Financial Navigator is from the TailorMed team.
Financial Navigation and Peer Support	Active comparator	Behavioral: Financial Navigation and Peer SupportFinancial navigation using software called TailorMed combined with peer support. The professional Financial Navigator is from the TailorMed team. Peer Supporters will be trained community members recruited from Michigan Medicine.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

18-75 years of age
diagnosis of diabetes with prescribed anti-hyperglycemic medication
most recent (within the past 6 months) recorded hemoglobin A1c (HbA1c) level of ≥7.5% for individuals ≤70 years and \&amp;gt;8.0% for individuals between 70-75 years in age
positive report of financial burden or cost-related non-adherence (CRN) using screening questions developed and validated from prior work 20-22
be willing to provide personal health information in order to effectively participate in the intervention

Key exclusion criteria (11 listed)

a diagnosis of a serious psychiatric disorder (e.g., schizophrenia)
active alcohol or illicit drug use
current pregnancy or planning pregnancy
taking a medication that alters glucose metabolism (e.g., oral steroids)
report a comorbidity expected to limit life span to \&amp;lt; 3 years

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
Financial Navigation and Peer SupportA combined intervention of technology-supported financial navigation and peer support: A professional financial navigator from TailorMed will use the software to assist participants in exploring options to reduce their specific economic barriers to treatment and care, and non-medical social risks. Participants will also be matched with a Peer Supporter to help improve the participants\' diabetes self-management.	Behavioural	Financial Navigation and Peer Support
Financial Navigation OnlyA professional financial navigator from TailorMed will use the software to assist participants in exploring options to reduce their specific economic barriers to treatment and care, and non-medical social risks.	Behavioural	Financial Navigation only

Primary outcome

A1c
Time frame: From enrollment to the end of participant study duration at 6 months
Collect A1c sample using A1c Now SelfCheck test kit
Blood Pressure
Time frame: From enrollment to the end of participant study duration at 6 months
Measure participant blood pressure using the Omron home blood pressure monitor. Both systolic and diastolic blood pressure will be measured.

9 secondary outcomes

Uptake of social care assistance
Time frame: From enrollment to the end of participant study duration at 6 months
Successfully having social/financial need address
Time frame: From enrollment to the end of participant study duration at 6 months
Cost-related non-adherence behaviors
Time frame: From enrollment to the end of participant study duration at 6 months
Out-of-pocket costs
Time frame: From enrollment to the end of participant study duration at 6 months
Diabetes-related social support
Time frame: From enrollment to the end of participant study duration at 6 months
Diabetes self-care behaviors
Time frame: From enrollment to the end of participant study duration at 6 months
Social needs screening
Time frame: From enrollment to the end of participant study duration at 6 months
Diabetes Distress
Time frame: From enrollment to the end of participant study duration at 6 months
Treatment-related financial stress
Time frame: From enrollment to the end of participant study duration at 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
Individual participant dataSharing planned: Yes. All of the individual participant data that underlie results in a publication, after de-identification.

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
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Recruiting
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 11 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: finished, as of the sponsor's last update on 5 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A1c (time frame: From enrollment to the end of participant study duration at 6 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?

On the ClinicalTrials.gov record for NCT06619834.

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 Mar 2026.