The Virtual Visit for Women With Gestational Diabetes

Not Applicable

Completed

• Conditions: Diabetes, Gestational
• Interventions: Device: 1-Self-monitoring of blood glucose; Device: 2-Self-weighing; Device: 3-Self-checking of blood pressure; Device: 4-Checking fetal heart rate; Procedure: 5-Visits with caregivers

• Registration Number: NCT02960295
• Lead Sponsor: Kaiser Permanente

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 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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-11-07
• Study First Posted: 2016-11-09
• Results First Submitted: 2018-04-10
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-04
• Last Update Submitted: 2019-02-04
• Results First Posted: 2019-02-26
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual visit	5-Visits with caregivers	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.
Virtual visit	1-Self-monitoring of blood glucose	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.
Virtual visit	4-Checking fetal heart rate	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.
Virtual visit	3-Self-checking of blood pressure	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.
Virtual visit	2-Self-weighing	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.

Primary Outcome Measures

Name	Time	Method
Compliance With Requirements for Frequency of Glucose Measures	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.

Secondary Outcome Measures

Name	Time	Method
Compliance With Self-weighing Requirements	1 year	Average percentage of weight checks per week in study, calculated as total weight checks in study/weeks in study x 100
Compliance With Blood Pressure Checking Requirements	1 year	Percentage of required once-weekly blood pressure checks calculated as total blood pressure checks in study/weeks in study x 100
Glucose Concentrations	1 year	Mean of all glucose measures during study, in mg/dl

Trial Locations

Locations (1)

Kaiser Permanente Southern California; 🇺🇸 Pasadena, California, United States