The Virtual Visit for Women With Gestational Diabetes
Condition: Diabetes, Gestational
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

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 description: 
      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.
    

Intervention name(s): 1-Self-monitoring of blood glucose; 2-Self-weighing; 3-Self-checking of blood pressure; 4-Checking fetal heart rate; 5-Visits with caregivers
Intervention type(s): Device; Device; Device; Device; Procedure
Intervention description(s): Self-monitoring of blood glucose 4 times daily: fasting and 1-hour after each meal. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment. Intervention: At every office visit and at every telephone ("virtual") visit the patient's physician will review glucose results and make adjustments in diet, activity, or medication to bring glucose into desired range.; Self-weighing on electronic scale at least once a week. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment. Consultation with the nutritionist will be obtained for women gaining in excess of or less than that indicated for her pre-pregnancy BMI, per Institute of Medicine (IOM) standards.; Self-checking of blood pressure at least weekly with sphygmomanometer. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment. Patients with elevated blood pressure will be requested to come to Obstetrics Triage immediately for further assessment.; Patient will record her fetus' heart rate with a Doppler device at least once weekly. The patient will immediately report to Labor and Delivery for any fetal heart rate below 100 beats per minute or greater than 160 beats per minute over a 10 minute observation period.Those reporting a fetal heart rate outside of the normal range will be requested to come to ObstetricTriage for further assessment.; Telephone visits will alternate with in-office visits.Those failing to keep appointments will be contacted and reappointed at a mutually convenient time.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic