Incentives and Glucose Adherence in Diabetes

Diabetes in Pregnancy Clinical Trial

Official title:

Incentive Models on Testing Adherence for Women With Diabetes During Pregnancy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03338829
• Other study ID #: 201603724
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 5, 2016
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2021
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: June 30, 2022
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• incarcerated, not English speaking

Related Conditions & MeSH terms

• Diabetes in Pregnancy
• Diabetes Mellitus
• Diabetes, Gestational
• Pregnancy in Diabetics

Intervention

Behavioral:
• Positive incentive
Compensation is paid for each glucose test completed
• 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

Locations

Country	Name	City	State
United States	University of Iowa Hospital and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Janet Andrews

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of glucose monitoring	The primary outcome measure will be assessed at monthly intervals and reported at the end of the pregnancy.	12 months