Trial Outcomes & Findings for Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM)-1 (NCT NCT04203173)

NCT ID: NCT04203173

Last Updated: 2026-07-24

Results Overview

Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

450 participants

Primary outcome timeframe

HbA1c at 12 months follow-up

Results posted on

2026-07-24

Participant Flow

Participant milestones

Participant milestones
Measure
FINANCE-DM Intervention
The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. FINANCE-DM: 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.
TIDES Intervention
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. Active Comparator: 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.
Overall Study
STARTED
224
226
Overall Study
COMPLETED
186
178
Overall Study
NOT COMPLETED
38
48

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM)-1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
FINANCE-DM Intervention
n=224 Participants
The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. FINANCE-DM: 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.
TIDES Intervention
n=226 Participants
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. Active Comparator: 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.
Total
n=450 Participants
Total of all reporting groups
Age, Continuous
56.5 years
STANDARD_DEVIATION 12.2 • n=9 Participants
58.8 years
STANDARD_DEVIATION 39.6 • n=27 Participants
57.7 years
STANDARD_DEVIATION 29.3 • n=267 Participants
Sex: Female, Male
Female
114 Participants
n=9 Participants
117 Participants
n=27 Participants
231 Participants
n=267 Participants
Sex: Female, Male
Male
110 Participants
n=9 Participants
109 Participants
n=27 Participants
219 Participants
n=267 Participants
Race/Ethnicity, Customized
Hispanic
23 Participants
n=9 Participants
22 Participants
n=27 Participants
45 Participants
n=267 Participants
Race/Ethnicity, Customized
Non-Hispanic White
128 Participants
n=9 Participants
131 Participants
n=27 Participants
259 Participants
n=267 Participants
Race/Ethnicity, Customized
Non-Hispanic Black
73 Participants
n=9 Participants
73 Participants
n=27 Participants
146 Participants
n=267 Participants
Region of Enrollment
United States
224 participants
n=9 Participants
226 participants
n=27 Participants
450 participants
n=267 Participants

PRIMARY outcome

Timeframe: HbA1c at 12 months follow-up

Population: Overall number of participants analyzed at 12months differs from participant flow chart, which represents analysis at 18months.

Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.

Outcome measures

Outcome measures
Measure
FINANCE-DM Intervention
n=197 Participants
The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. FINANCE-DM: 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.
TIDES Intervention
n=190 Participants
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. Active Comparator: 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.
Glycemic Control (HbA1c)
8.39 mean percent HbA1c
Standard Deviation 1.67
8.61 mean percent HbA1c
Standard Deviation 1.57

SECONDARY outcome

Timeframe: HbA1c at 18 months follow-up

Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.

Outcome measures

Outcome measures
Measure
FINANCE-DM Intervention
n=186 Participants
The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. FINANCE-DM: 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.
TIDES Intervention
n=178 Participants
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. Active Comparator: 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.
Glycemic Control (HbA1c)
8.39 mean percent HbA1c
Standard Deviation 1.75
8.72 mean percent HbA1c
Standard Deviation 1.77

Adverse Events

FINANCE-DM Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

TIDES Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

SUNY Buffalo

Phone: 716-829-2364

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place