Type 2 DiabetesFINANCE-DMNCT04203173
Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM)-1
A study testing FINANCE-DM and Active Comparator in people with Type 2 Diabetes, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The objective of this protocol is to answer the questions: 1) Are financial incentives layered upon nurse education and home telemonitoring superior to nurse education and home telemonitoring alone in improving metabolic control long term? 2) Are the effects of financial incentives on metabolic control sustained once… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- FINANCE-DM and Active Comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=21 years;
- Clinical diagnosis of T2DM and HbA1c >=8% at the screening visit;
- Self-identified as White, AA or HA;
- Subject must be willing to use the FORA monitoring system for 12 months;
- Subjects must have access to a landline, Ethernet or cellphone for FORA data uploads for the study period; and 6) Ability to communicate in English.
Who cannot join
- Mental confusion on interview suggesting significant dementia;
- Participation in other diabetes clinical trials;
- Alcohol or drug abuse/dependency;
- Active psychosis or acute mental disorder; and
- Life expectancy <18 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York at Buffalo
Buffalo, New York, 14203
About this study
Official title: Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes - FINANCE-DM
The objective of this protocol is to answer the questions: 1) Are financial incentives layered upon nurse education and home telemonitoring superior to nurse education and home telemonitoring alone in improving metabolic control long term? 2) Are the effects of financial incentives on metabolic control sustained once the incentives are withdrawn? and 3) Are financial incentives efficacious within and consistent across racial/ethnic groups? This study provides a unique opportunity to address these gaps in the literature. Investigators propose a randomized controlled trial to test the efficacy of a Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM) intervention comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives; compared to an active control group (nurse education and home telemonitoring alone). The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups.
Read the detailed description
Study Overview. The overarching aim of this proposal is to test the efficacy of structured financial incentives intervention (FINANCE-DM) comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives; compared to an active control group (nurse education and home telemonitoring alone) on glycemic control. The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups. Equal number of patients from three racial/ethnic groups (150 Whites, 150 AAs and 150 HAs, total sample of 450) will be randomized to FINANCE-DM intervention (n=225) or an active comparator group (n=225), so that within each racial/ethnic group, half (75 patients) will be randomized to the FINANCE-DM intervention group and the other half (75 patients) will be randomized to the active comparator group. Primary aims are to test overall efficacy across combined racial/ethnic groups; efficacy within racial/ethnic groups and cost effectiveness for the primary endpoint (glycemic control). Secondary aim is to test efficacy on secondary endpoints including BP, LDL, QOL and self-care behaviors. Each patient will be followed for 12 months (long-term effect) and 18 months (sustainability effect), with study visits at baseline, 3, 6, 9, 12 and 18 months. The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. The active comparator group will receive the same nurse education and home telemonitoring intervention as the FINANCE-DM group, on the same schedule, and for the same duration . The only difference is that participants will not receive structured financial incentives.
- Conditions
- Type 2 Diabetes
- Being tested
- FINANCE-DM, Active Comparator
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FINANCE-DMBehavioural
The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. Patients randomized to FINANCE-DM will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. BG and BP will be measured daily and results will be uploaded to a secure server. A nurse educator will review the glucose and BP readings and use them to tailor and reinforce behavior change during weekly telephone-delivered diabetes education and skills training session. Participants will also receive financial rewards for: 1) uploading glucose measurements; 2) participating in telephone delivered educational sessions; and 3) absolute percentage drops in HbA1c from baseline at each 3-month follow-up intervals.
Active ComparatorBehavioural
Patients randomized to the active comparator group will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. BG and BP will be measured daily and results will be uploaded to a secure server. A nurse educator will review the glucose and BP readings and use them to tailor and reinforce behavior change during weekly telephone-delivered diabetes education and skills training session.
| Study group | Role | What they receive |
|---|---|---|
| FINANCE-DM Intervention | Experimental | The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. Receives: Behavioral: FINANCE-DM |
| TIDES Intervention | Active comparator | Patients randomized to the active comparator group will be assigned the FORA 2-in-1 Telehealth System. A nurse educator will review the glucose and BP readings and use them to tailor and reinforce behavior change. Receives: Behavioral: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control (HbA1c)
Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.
Measured: HbA1c at 12 months follow-up
Secondary outcomes (1)
Glycemic Control (HbA1c)
Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.
Measured: HbA1c at 18 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Dec 2019
- Primary completion30 Jun 2025
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonard Ehianu Egede, State University of New York at Buffalo
- Investigators
- Leonard E Egede, MD, MS, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203173
- Sponsor's protocol ID
- 1R01DK120861
- Acronym
- FINANCE-DM
- Status last verified
- Jul 2026
- First submitted
- 26 Nov 2019
- Last updated
- 24 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Egede LE, Walker R, Williams JS, Knapp R, Dismuke CE, Davidson T, Campbell JA. Financial Incentives and Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM): a trial protocol. BMJ Open. 2020 Dec 22;10(12):e043760. doi: 10.1136/bmjopen-2020-043760.
PubMed 33371048
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes - FINANCE-DM
- ClinicalTrials.gov ID
- NCT04203173
- Acronym / sponsor ID
- FINANCE-DM / 1R01DK120861
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Posted 24 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this protocol is to answer the questions: 1) Are financial incentives layered upon nurse education and home telemonitoring superior to nurse education and home telemonitoring alone in improving metabolic control long term? 2) Are the effects of financial incentives on metabolic control sustained once the incentives are withdrawn? and 3) Are financial incentives efficacious within and consistent across racial/ethnic groups? This study provides a unique opportunity to address these gaps in the literature. Investigators propose a randomized controlled trial to test the efficacy of a Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM) intervention comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives; compared to an active control group (nurse education and home telemonitoring alone). The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups.
Detailed description
Study Overview. The overarching aim of this proposal is to test the efficacy of structured financial incentives intervention (FINANCE-DM) comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives; compared to an active control group (nurse education and home telemonitoring alone) on glycemic control. The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups. Equal number of patients from three racial/ethnic groups (150 Whites, 150 AAs and 150 HAs, total sample of 450) will be randomized to FINANCE-DM intervention (n=225) or an active comparator group (n=225), so that within each racial/ethnic group, half (75 patients) will be randomized to the FINANCE-DM intervention group and the other half (75 patients) will be randomized to the active comparator group. Primary aims are to test overall efficacy across combined racial/ethnic groups; efficacy within racial/ethnic groups and cost effectiveness for the primary endpoint (glycemic control). Secondary aim is to test efficacy on secondary endpoints including BP, LDL, QOL and self-care behaviors. Each patient will be followed for 12 months (long-term effect) and 18 months (sustainability effect), with study visits at baseline, 3, 6, 9, 12 and 18 months. The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. The active comparator group will receive the same nurse education and home telemonitoring intervention as the FINANCE-DM group, on the same schedule, and for the same duration . The only difference is that participants will not receive structured financial incentives.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FINANCE-DM Intervention | Experimental | Behavioral: FINANCE-DMThe FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. |
| TIDES Intervention | Active comparator | Behavioral: Active ComparatorPatients randomized to the active comparator group will be assigned the FORA 2-in-1 Telehealth System. A nurse educator will review the glucose and BP readings and use them to tailor and reinforce behavior change. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >=21 years;
- Clinical diagnosis of T2DM and HbA1c >=8% at the screening visit;
- Self-identified as White, AA or HA;
- Subject must be willing to use the FORA monitoring system for 12 months;
- Subjects must have access to a landline, Ethernet or cellphone for FORA data uploads for the study period; and 6) Ability to communicate in English.
Key exclusion criteria (5 listed)
- Mental confusion on interview suggesting significant dementia;
- Participation in other diabetes clinical trials;
- Alcohol or drug abuse/dependency;
- Active psychosis or acute mental disorder; and
- Life expectancy <18 months.
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 |
|---|---|---|
| FINANCE-DMThe FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. Patients randomized to FINANCE-DM will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. BG and BP will be measured daily and results will be uploaded to a secure server. A nurse educator will review the glucose and BP readings and use them to tailor and reinforce behavior change during weekly telephone-delivered diabetes education and skills training session. Participants will also receive financial rewards for: 1) uploading glucose measurements; 2) participating in telephone delivered educational sessions; and 3) absolute percentage drops in HbA1c from baseline at each 3-month follow-up intervals. | Behavioural | FINANCE-DM Intervention |
| Active ComparatorPatients randomized to the active comparator group will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. BG and BP will be measured daily and results will be uploaded to a secure server. A nurse educator will review the glucose and BP readings and use them to tailor and reinforce behavior change during weekly telephone-delivered diabetes education and skills training session. | Behavioural | TIDES Intervention |
Primary outcome
Glycemic Control (HbA1c)
Time frame: HbA1c at 12 months follow-up
Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.
1 secondary outcome
Glycemic Control (HbA1c)
Time frame: HbA1c at 18 months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33371048Egede LE, Walker R, Williams JS, Knapp R, Dismuke CE, Davidson T, Campbell JA. Financial Incentives and Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM): a trial protocol. BMJ Open. 2020 Dec 22;10(12):e043760. doi: 10.1136/bmjopen-2020-043760.
- PDF of study protocol paperLink provided by the sponsor.
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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.
Leonard E Egede, MD, MS principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FINANCE-DM and Active Comparator in people with Type 2 Diabetes, run by State University of New York at Buffalo 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 5 inclusion and 5 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 24 Jul 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?
Yes. Results are posted in the registry (first posted 24 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glycemic Control (HbA1c) (time frame: HbA1c at 12 months follow-up). 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 NCT04203173, which also lists 1 linked publication.
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 24 Jul 2026.