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Incentives and Glucose Adherence in Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03338829
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : June 18, 2018
Information provided by (Responsible Party):
Janet Andrews, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Diabetes in Pregnancy Behavioral: Positive incentive Behavioral: Loss aversion Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women eligible
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • incarcerated, not English speaking

Information from the National Library of Medicine

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 identifier (NCT number): NCT03338829

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Contact: Sarah Wernimont, MD, PhD

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United States, Iowa
University of Iowa Hospital and Clinics Recruiting
Iowa City, Iowa, United States, 52246
Contact: Janet Andrews, MD   
Contact: Sarah Wernimont, MD PhD   
Sponsors and Collaborators
Janet Andrews
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Principal Investigator: Janet Andrews, MD University of Iowa

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Responsible Party: Janet Andrews, Incentive Models on Testing Adherence for Women With Diabetes During Pregnancy, University of Iowa Identifier: NCT03338829     History of Changes
Other Study ID Numbers: 201603724
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pregnancy in Diabetics
Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Aversive Agents
Molecular Mechanisms of Pharmacological Action
Abuse-Deterrent Formulations
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents