Clinical Trial: The Virtual Visit for Women With Gestational Diabetes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Virtual Visit for Women With Gestational Diabetes

Brief Summary:

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.


Detailed Summary: 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.
Sponsor: Kaiser Permanente

Current Primary Outcome: Compliance with frequency of glucose measures [ Time Frame: 1 year ]

Total number of measures per day


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Compliance with self-weighing requirements [ Time Frame: 1 year ]
    Frequency of self-weighing (total number of measures per week).
  • Compliance with blood pressure checking requirements [ Time Frame: 1 year ]
    Frequency of blood pressure measurements (total number of measures per week).
  • Glucose measures [ Time Frame: 1 year ]
    Mean total, fasting, postprandial glucose in mg/dl. Comparison between glucose concentrations on enrollment and at end of study
  • Weight gain [ Time Frame: 1 year ]
    Mean weekly weight gain in pounds per week from weeks 13 to study enrollment and from study enrollment to delivery
  • Glucose concentrations [ Time Frame: 1 year ]
    Mean of all glucose measures during study, in mg/dl


Original Secondary Outcome: Same as current

Information By: Kaiser Permanente

Dates:
Date Received: October 18, 2016
Date Started: September 2014
Date Completion:
Last Updated: November 7, 2016
Last Verified: October 2016