Incentives and Glucose Adherence in Diabetes

Incentive Models on Testing Adherence for Women With Diabetes During Pregnancy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes in Pregnancy
• Intervention / Treatment: Behavioral: Positive incentive; Behavioral: Loss aversion

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52246
      • University of Iowa Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• incarcerated, not English speaking

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: Janet Andrews
• Investigators: Principal Investigator: Janet Andrews, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2016
• Primary Completion (Actual): December 18, 2019
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: 201603724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No