Incentives and Glucose Adherence in Diabetes

Study Overview
=================
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 (<28 weeks) and followed in our outpatient clinic. Participants are randomized into one of three groups: control group - receive compensation at time of enrollment, positive incentive group - receive compensation per test completed 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

Official Title
-----------------
Incentive Models on Testing Adherence for Women With Diabetes During Pregnancy

Conditions
-----------------
Diabetes in Pregnancy

Intervention / Treatment
-----------------
* Behavioral: Positive incentive
* Behavioral: Loss aversion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women with insulin dependent diabetes prior to 28 weeks gestation. Exclusion Criteria: incarcerated, not English speaking

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control arm will received compensation at time of enrollment for agreeing to participate. | |
| Experimental: Positive Incentive<br>The positive incentive arm will receive compensation per prescribed test, payable every month based on testing adherence. | Behavioral: Positive incentive<br>* Compensation is paid for each glucose test completed<br>|
| Experimental: Loss Aversion<br>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<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of glucose monitoring | The primary outcome measure will be assessed at monthly intervals and reported at the end of the pregnancy. | 12 months |