Utilizing mHealth to Improve Diabetes in an Obstetric Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Completeness and accuracy of blood glucose record
研究概览
简要总结
This project will utilize MHealth technology to address the barriers providers and obstetric patients experience when reporting blood glucose results. Half of the participants will record their blood glucose values with the assistance of a smartphone device, the other half will continue in the traditional care method of the clinic.
详细描述
This will be a prospective single center randomized trial piloting the use of mHealth applications in an obstetric population with diabetes. Participants will be enrolled in the study after the diagnosis of diabetes is made in pregnancy for those with gestational diabetes, or for patients with preexisting diabetes they will be enrolled upon initiation of prenatal care. Participants will be randomized to traditional care or mHealth intervention. Outcomes will include completeness and accuracy of the participant glucose log, unscheduled health care access episodes in the pregnancy, patient satisfaction, percentage of glucose values at goal and percent change in Hemoglobin A1C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant, English speaking, Diagnosed with diabetes during pregnancy or with known preexisting diabetes, has smartphone, sees URMC OBGYN for obstetric care in pregnancy.
排除标准
- •Not English speaking, does not have smartphone, unable to consent.
结局指标
主要结局
Completeness and accuracy of blood glucose record
时间窗: Every 2 weeks through study completion, up to 42 weeks
The number of values reported to the provider out of the number that should have been collected during the time period, expressed as a percent, as well as the number of values reported that were verified accurate by the meter out of the total number of values reported in the time frame expressed as a percent.
次要结局
- % Change in Hemoglobin A1C(Once prior to exiting the study, up to 42 weeks)
- Clinic visits(through study completion, up to 42 weeks)
- Patient Satisfaction(Once prior to exiting the study, an average of 42 weeks)
- Glucose values at goal(Every 2 weeks through study completion, up to 42 weeks)
- Unscheduled health care access episodes(through study completion, up to 42 weeks)
研究者
Lisa Gray
Assistant Professor
University of Rochester