The Virtual Visit for Women With Gestational Diabetes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes, Gestational

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Virtual visit

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.

Group Type EXPERIMENTAL

1-Self-monitoring of blood glucose

Intervention Type DEVICE

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.

2-Self-weighing

Intervention Type DEVICE

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.

3-Self-checking of blood pressure

Intervention Type DEVICE

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.

4-Checking fetal heart rate

Intervention Type DEVICE

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.

5-Visits with caregivers

Intervention Type PROCEDURE

Telephone visits will alternate with in-office visits.Those failing to keep appointments will be contacted and reappointed at a mutually convenient time.

Interventions

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1-Self-monitoring of blood glucose

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.

Intervention Type DEVICE

2-Self-weighing

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.

Intervention Type DEVICE

3-Self-checking of blood pressure

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.

Intervention Type DEVICE

4-Checking fetal heart rate

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.

Intervention Type DEVICE

5-Visits with caregivers

Telephone visits will alternate with in-office visits.Those failing to keep appointments will be contacted and reappointed at a mutually convenient time.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes