Incentives and Glucose Adherence in Diabetes
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|ClinicalTrials.gov Identifier: NCT03338829|
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : June 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes in Pregnancy||Behavioral: Positive incentive Behavioral: Loss aversion||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Incentive Models on Testing Adherence for Women With Diabetes During Pregnancy|
|Actual Study Start Date :||May 5, 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||March 2020|
No Intervention: Control
The control arm will received compensation at time of enrollment for agreeing to participate.
Experimental: Positive Incentive
The positive incentive arm will receive compensation per prescribed test, payable every month based on testing adherence.
Behavioral: Positive incentive
Compensation is paid for each glucose test completed
Experimental: 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
Behavioral: 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 [ Time Frame: 12 months ]The primary outcome measure will be assessed at monthly intervals and reported at the end of the pregnancy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338829
|Contact: Sarah Wernimont, MD, PhDfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa Hospital and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52246|
|Contact: Janet Andrews, MD email@example.com|
|Contact: Sarah Wernimont, MD PhD firstname.lastname@example.org|
|Principal Investigator:||Janet Andrews, MD||University of Iowa|