The Virtual Visit for Women With Gestational Diabetes

Kaiser Permanente

Status: Completed

Conditions: Diabetes, Gestational

Treatments: Device: 2-Self-weighing; Device: 1-Self-monitoring of blood glucose; Procedure: 5-Visits with caregivers; Device: 4-Checking fetal heart rate; Device: 3-Self-checking of blood pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT02960295

10539 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Diagnosis of gestational diabetes
2. Singleton pregnancy
3. <32 weeks gestation
4. Age 18-45 years
5. Fluent and literate in English or Spanish
6. Have a cellphone with capability of internet access.

Exclusion criteria

1. Multiple gestations (twins or higher)
2. Have a history of fetal demise
3. 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Virtual visit

Experimental group

Description:

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.

Treatment:

Device: 2-Self-weighing

Procedure: 5-Visits with caregivers

Device: 1-Self-monitoring of blood glucose

Device: 4-Checking fetal heart rate

Device: 3-Self-checking of blood pressure