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临床试验/NCT02960295
NCT02960295已完成不适用

The Virtual Visit for Women With Gestational Diabetes

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Compliance With Requirements for Frequency of Glucose Measures

研究概览

简要总结

This is a feasibility study of care for women with gestational diabetes (GDM) using electronic equipment to participate in virtual office visits.

Participants will be trained in the use of glucose meters, scales, and sphygmomanometers which are Bluetooth connected to an app on their cellphones. Fetal well-being will be assessed with Dopplers and kick counts. Care will be delivered by alternate in-office and telephone visits.

详细描述

The core elements of a prenatal visit for any pregnant woman include assessment of BP, weight, and presence of fetal heart activity. The treatment of GDM additionally requires the measurement of and review of maternal glycemia. Technology exists for patients to measure these parameters and to relay this information securely directly from these devices via the internet to the healthcare provider's office. A key element of antepartum care for GDM, self-monitoring of blood glucose (SMBG), has for some years been conducted with memory-based portable glucose meters. To assure accuracy in reports of patient measurements, it is important that all devices be of a design wherein results of measures of patient parameters are transmitted in unedited fashion directly devices to the health care provider. While no data exists about the accuracy of self-reporting of patient weight and blood pressure, intentional or unintentional alteration in reports of self-monitored glucose results is a known risk of reliance on patient self-reported data. This pilot study will explore the feasibility of the use of this technology from patients' homes in lieu of an office visit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of gestational diabetes
  • Singleton pregnancy
  • <32 weeks gestation
  • Age 18-45 years
  • Fluent and literate in English or Spanish
  • Have a cellphone with capability of internet access.

排除标准

  • Multiple gestations (twins or higher)
  • Have a history of fetal demise
  • Have a history of chronic health problems that might affect outcomes (such as HIV, treatment with steroids, significant cardiac or renal disease, or chronic hypertension), and those who had bariatric surgery.

研究组 & 干预措施

Virtual visit

Experimental
  1. Self-monitoring of blood glucose (four times daily).
  2. Self-weighing (weekly).
  3. Self-checking of blood pressure (weekly).
  4. Checking fetal heart rate (weekly).
  5. Visits with caregivers.

干预措施: 1-Self-monitoring of blood glucose (Device)

Virtual visit

Experimental
  1. Self-monitoring of blood glucose (four times daily).
  2. Self-weighing (weekly).
  3. Self-checking of blood pressure (weekly).
  4. Checking fetal heart rate (weekly).
  5. Visits with caregivers.

干预措施: 2-Self-weighing (Device)

Virtual visit

Experimental
  1. Self-monitoring of blood glucose (four times daily).
  2. Self-weighing (weekly).
  3. Self-checking of blood pressure (weekly).
  4. Checking fetal heart rate (weekly).
  5. Visits with caregivers.

干预措施: 3-Self-checking of blood pressure (Device)

Virtual visit

Experimental
  1. Self-monitoring of blood glucose (four times daily).
  2. Self-weighing (weekly).
  3. Self-checking of blood pressure (weekly).
  4. Checking fetal heart rate (weekly).
  5. Visits with caregivers.

干预措施: 4-Checking fetal heart rate (Device)

Virtual visit

Experimental
  1. Self-monitoring of blood glucose (four times daily).
  2. Self-weighing (weekly).
  3. Self-checking of blood pressure (weekly).
  4. Checking fetal heart rate (weekly).
  5. Visits with caregivers.

干预措施: 5-Visits with caregivers (Procedure)

结局指标

主要结局

Compliance With Requirements for Frequency of Glucose Measures

时间窗: 1 year

Each patient is requested to check her blood glucose four times a day: fasting and one hour after the first bite of each meal. Compliance with this requirement will be measured for each patient by dividing the number of daily glucose checks actually performed by the number of days in the study.

次要结局

  • Compliance With Self-weighing Requirements(1 year)
  • Compliance With Blood Pressure Checking Requirements(1 year)
  • Glucose Concentrations(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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