跳至主要内容
临床试验/NCT03338829
NCT03338829已完成不适用

Incentive Models on Testing Adherence for Women With Diabetes During Pregnancy

University of Iowa2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2016年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
2
主要终点
Frequency of Glucose Monitoring

研究概览

简要总结

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.

详细描述

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 (<29 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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women with insulin dependent diabetes prior to 29 weeks gestation.

排除标准

  • incarcerated, not English speaking

结局指标

主要结局

Frequency of Glucose Monitoring

时间窗: Pregnancy

Patients with type 1 diabetes were advised to monitor glucose seven times daily (fasting, 1hour post breakfast, pre- lunch, 1 hour post lunch, pre-dinner and 1 hour post dinner and nightly). Patients with type 2 and gestational diabetes were advised to have four glucose tests daily (fasting and 1hour post breakfast, lunch and dinner). Adherence to glucose testing was determined by the number of tests daily divided by the # of recommended tests daily and averaged over the course of the study as previously described

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验