An interventional study of Positive incentive and Loss aversion in Diabetes in Pregnancy, sponsored by University of Iowa. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by University of Iowa · Not applicable, Interventional, and Other
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.
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:
Primary outcome of the study is frequency of prescribed glucose testing in pregnancy
Exclusion Criteria:
The control arm will receive compensation at time of enrollment for agreeing to participate.
The positive incentive arm will receive compensation per prescribed test, payable every month based on testing adherence.
Behavioral: Positive incentive
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
Behavioral: Loss aversion
Compensation is paid for each glucose test completed
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
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
| Milestone | Control | Positive Incentive | Loss Aversion |
|---|---|---|---|
| Started | 42 | 43 | 45 |
| Completed | 37 | 39 | 41 |
| Not completed | 5 | 4 | 4 |
| Withdrew: Lost to follow-up | 4 | 2 | 4 |
| Withdrew: Pregnancy loss | 1 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 0 |
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
| percentage of overall adherence | Control | Positive Incentive | Loss Aversion |
|---|---|---|---|
| Frequency of Glucose Monitoring | 57.31 ± 5.12 | 58.48 ± 4.60 | 69.08 ± 3.75 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Positive Incentive | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| Loss Aversion | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Age, Continuous(years) | Positive Incentive | Control | Loss Aversion | Total |
|---|---|---|---|---|
| Mean | 30 ± 0.79 | 31 ± 0.92 | 32 ± 0.93 | 31 ± 0.51 |
| Sex: Female, Male(Participants) | Positive Incentive | Control | Loss Aversion | Total |
|---|---|---|---|---|
| Female | 39 | 37 | 41 | 117 |
| Male | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Positive Incentive | Control | Loss Aversion | Total |
|---|---|---|---|---|
| Race/Ethnicity — White | 26 | 28 | 30 | 84 |
| Race/Ethnicity — Black | 7 | 4 | 7 | 18 |
| Race/Ethnicity — Hispanic/Latina | 3 | 4 | 3 | 10 |
| Race/Ethnicity — Asian | 1 | 0 | 1 | 2 |
| Race/Ethnicity — Multiracial | 2 | 1 | 0 | 3 |
| Region of Enrollment(Participants) | Positive Incentive | Control | Loss Aversion | Total |
|---|---|---|---|---|
| United States | 39 | 37 | 41 | 117 |
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University of Iowa