Trial Outcomes & Findings for Incentives and Glucose Adherence in Diabetes (NCT NCT03338829)
NCT ID: NCT03338829
Last Updated: 2025-07-30
Results Overview
Patients with type 1 diabetes were advised to monitor glucose seven times daily (fasting, 1hour post breakfast, pre- lunch, 1 hour post lunch, pre-dinner and 1 hour post dinner and nightly). Patients with type 2 and gestational diabetes were advised to have four glucose tests daily (fasting and 1hour post breakfast, lunch and dinner). Adherence to glucose testing was determined by the number of tests daily divided by the # of recommended tests daily and averaged over the course of the study as previously described
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
Pregnancy
Results posted on
2025-07-30
Participant Flow
Participant milestones
| Measure |
Control
The control arm will receive $25.00 at time of enrollment for agreeing to participate.
|
Positive Incentive
The positive incentive arm will receive $0.10 per prescribed test, payable every month based on testing adherence. For those with type 2 diabetes, the maximum daily payment will be $0.40. For those with type 1 diabetes , the maximum payment will be $0.70 per day.
Positive incentive: Compensation is paid for each glucose test completed
|
Loss Aversion
The loss aversion arm will have $100 deposited into a University of Iowa Women's Health account. The participant will then "lose" compensation depending on actual adherence to recommended testing.
For 95% or more adherence, no money will be lost. For 85-94% adherence, $25 will be removed from account. For 70-84% adherence, $50 will be removed from account. For less than 69% adherence, $75 will be removed.
Loss aversion: Fixed compensation is offered to patients and they can earn a range of compensation at the completion of pregnancy depending on overall glucose testing adherence
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
43
|
45
|
|
Overall Study
COMPLETED
|
37
|
39
|
41
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
4
|
Reasons for withdrawal
| Measure |
Control
The control arm will receive $25.00 at time of enrollment for agreeing to participate.
|
Positive Incentive
The positive incentive arm will receive $0.10 per prescribed test, payable every month based on testing adherence. For those with type 2 diabetes, the maximum daily payment will be $0.40. For those with type 1 diabetes , the maximum payment will be $0.70 per day.
Positive incentive: Compensation is paid for each glucose test completed
|
Loss Aversion
The loss aversion arm will have $100 deposited into a University of Iowa Women's Health account. The participant will then "lose" compensation depending on actual adherence to recommended testing.
For 95% or more adherence, no money will be lost. For 85-94% adherence, $25 will be removed from account. For 70-84% adherence, $50 will be removed from account. For less than 69% adherence, $75 will be removed.
Loss aversion: Fixed compensation is offered to patients and they can earn a range of compensation at the completion of pregnancy depending on overall glucose testing adherence
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
4
|
|
Overall Study
Pregnancy loss
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
Baseline Characteristics
Incentives and Glucose Adherence in Diabetes
Baseline characteristics by cohort
| Measure |
Positive Incentive
n=39 Participants
The positive incentive arm will receive compensation per prescribed test, payable every month based on testing adherence.
Positive incentive: Compensation is paid for each glucose test completed
|
Control
n=37 Participants
The control arm will receive compensation at time of enrollment for agreeing to participate.
|
Loss Aversion
n=41 Participants
The loss aversion arm will have compensation deposited into a University of Iowa Women's Health account. The participant will then "lose" compensation depending on actual adherence to recommended testing
Loss aversion: Fixed compensation is offered to patients and they can earn a range of compensation at the completion of pregnancy depending on overall glucose testing adherence
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 0.79 • n=99 Participants
|
31 years
STANDARD_DEVIATION 0.92 • n=107 Participants
|
32 years
STANDARD_DEVIATION 0.93 • n=206 Participants
|
31 years
STANDARD_DEVIATION 0.51 • n=7 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
117 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
26 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
84 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic/Latina
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Multiracial
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
117 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: PregnancyPatients with type 1 diabetes were advised to monitor glucose seven times daily (fasting, 1hour post breakfast, pre- lunch, 1 hour post lunch, pre-dinner and 1 hour post dinner and nightly). Patients with type 2 and gestational diabetes were advised to have four glucose tests daily (fasting and 1hour post breakfast, lunch and dinner). Adherence to glucose testing was determined by the number of tests daily divided by the # of recommended tests daily and averaged over the course of the study as previously described
Outcome measures
| Measure |
Control
n=37 Participants
The control arm will receive compensation at time of enrollment for agreeing to participate.
|
Positive Incentive
n=39 Participants
The positive incentive arm will receive compensation per prescribed test, payable every month based on testing adherence.
Positive incentive: Compensation is paid for each glucose test completed
|
Loss Aversion
n=41 Participants
The loss aversion arm will have compensation deposited into a University of Iowa Women's Health account. The participant will then "lose" compensation depending on actual adherence to recommended testing
Loss aversion: Fixed compensation is offered to patients and they can earn a range of compensation at the completion of pregnancy depending on overall glucose testing adherence
|
|---|---|---|---|
|
Frequency of Glucose Monitoring
|
57.31 percentage of overall adherence
Standard Error 5.12
|
58.48 percentage of overall adherence
Standard Error 4.60
|
69.08 percentage of overall adherence
Standard Error 3.75
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Positive Incentive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Loss Aversion
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place