Incentives and Glucose Adherence in Diabetes

Not Applicable

• Conditions: Diabetes in Pregnancy
• Interventions: Behavioral: Positive incentive; Behavioral: Loss aversion

• Registration Number: NCT03338829
• Lead Sponsor: Janet Andrews

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:

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

Study Timeline

• Study Start: 2016-05-05
• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-09
• Primary Completion: 2019-12-18
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-04
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• pregnant women with insulin dependent diabetes prior to 28 weeks gestation.

Exclusion Criteria

• incarcerated, not English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive Incentive	Positive incentive	The positive incentive arm will receive compensation per prescribed test, payable every month based on testing adherence.
Loss Aversion	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

Primary Outcome Measures

Name	Time	Method
Frequency of glucose monitoring	12 months	The primary outcome measure will be assessed at monthly intervals and reported at the end of the pregnancy.

Trial Locations

Locations (1)

University of Iowa Hospital and Clinics; 🇺🇸 Iowa City, Iowa, United States