Diabetes in Pregnancy
Conditions
Brief summary
Diabetes in pregnancy carries significant pregnancy specific risks and requires frequent glucose monitoring to reduce these risks. This project compares the effect of two incentive schemes on adherence rates of glucose testing in pregnancy.
Detailed description
Diabetes in pregnancy is associated with increased risks of maternal and fetal complications and can be challenging to manage due to increasing insulin requirements with advancing gestational age. Based on standard of care guidelines, patients with diabetes check their blood glucose at least 4 times per day. Optimal management requires frequent glucose self-monitoring and active management of abnormal blood sugars and medications by clinicians. Poorly controlled diabetes has both significant maternal and neonatal consequences: Improving test adherence could benefit both the pregnant woman and her fetus. In this study, we propose to test the effect of two incentive schemes on rates of glucose monitoring on pregnant women with diabetes requiring medication. Pregnant women with diabetes requiring medication are invited to participate if they meet specific inclusion criteria (\<29 weeks) and followed in our outpatient clinic. Participants are randomized into one of three groups: 1. control group - receive compensation at time of enrollment, 2. positive incentive group - receive compensation per test completed 3. loss aversion group - receive between a range of compensation depending on their overall level of adherence. Primary outcome of the study is frequency of prescribed glucose testing in pregnancy
Interventions
BEHAVIORALPositive incentive
Compensation is paid for each glucose test completed
BEHAVIORALLoss 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
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* pregnant women with insulin dependent diabetes prior to 29 weeks gestation.
Exclusion criteria
* incarcerated, not English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Glucose Monitoring | Pregnancy | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Positive Incentive 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 | 39 |
| Control The control arm will receive compensation at time of enrollment for agreeing to participate. | 37 |
| Loss Aversion 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 | 41 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 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
| Characteristic | Positive Incentive | Control | Loss Aversion | Total |
|---|---|---|---|---|
| Age, Continuous | 30 years STANDARD_DEVIATION 0.79 | 31 years STANDARD_DEVIATION 0.92 | 32 years STANDARD_DEVIATION 0.93 | 31 years STANDARD_DEVIATION 0.51 |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 7 Participants | 4 Participants | 7 Participants | 18 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/Latina | 3 Participants | 4 Participants | 3 Participants | 10 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Multiracial | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 26 Participants | 28 Participants | 30 Participants | 84 Participants |
| Region of Enrollment United States | 39 Participants | 37 Participants | 41 Participants | 117 Participants |
| Sex: Female, Male Female | 39 Participants | 37 Participants | 41 Participants | 117 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 39 | 0 / 41 |
| other Total, other adverse events | 0 / 37 | 0 / 39 | 0 / 41 |
| serious Total, serious adverse events | 0 / 37 | 0 / 39 | 0 / 41 |
Outcome results
Primary
Frequency of Glucose Monitoring
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
Time frame: Pregnancy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Frequency of Glucose Monitoring | 57.31 percentage of overall adherence | Standard Error 5.12 |
| Positive Incentive | Frequency of Glucose Monitoring | 58.48 percentage of overall adherence | Standard Error 4.6 |
| Loss Aversion | Frequency of Glucose Monitoring | 69.08 percentage of overall adherence | Standard Error 3.75 |