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.
COMPLETED
NA
450 participants
HbA1c at 12 months follow-up
2026-07-24
Participant Flow
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
| 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-upPopulation: 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
| 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-upBlood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.
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
TIDES Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place