Back to resultsIncentives and Glucose Adherence in Diabetes
Primary Purpose
Diabetes in Pregnancy
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive incentive
Loss aversion
Sponsored by
About this trial
This is an interventional other trial for Diabetes in Pregnancy
Eligibility Criteria
Inclusion Criteria:
- pregnant women with insulin dependent diabetes prior to 28 weeks gestation.
Exclusion Criteria:
- incarcerated, not English speaking
Sites / Locations
- University of Iowa Hospital and Clinics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
Positive Incentive
Loss Aversion
Arm Description
The control arm will received compensation at time of enrollment for agreeing to participate.
The positive incentive arm will receive compensation per prescribed test, payable every month based on testing adherence.
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
Outcomes
Primary Outcome Measures
Frequency of glucose monitoring
The primary outcome measure will be assessed at monthly intervals and reported at the end of the pregnancy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03338829
Brief Title
Incentives and Glucose Adherence in Diabetes
Official Title
Incentive Models on Testing Adherence for Women With Diabetes During Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 5, 2016 (Actual)
Primary Completion Date
December 18, 2019 (Actual)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Janet Andrews
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes in Pregnancy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control arm will received compensation at time of enrollment for agreeing to participate.
Arm Title
Positive Incentive
Arm Type
Experimental
Arm Description
The positive incentive arm will receive compensation per prescribed test, payable every month based on testing adherence.
Arm Title
Loss Aversion
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Positive incentive
Intervention Description
Compensation is paid for each glucose test completed
Intervention Type
Behavioral
Intervention Name(s)
Loss aversion
Intervention Description
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 Measure Information:
Title
Frequency of glucose monitoring
Description
The primary outcome measure will be assessed at monthly intervals and reported at the end of the pregnancy.
Time Frame
12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women eligible
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
pregnant women with insulin dependent diabetes prior to 28 weeks gestation.
Exclusion Criteria:
incarcerated, not English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Andrews, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Incentives and Glucose Adherence in Diabetes
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