CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
1-Self-monitoring of blood glucose +4 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02960295
NCT02960295N/ACompleted

The Virtual Visit for Women With Gestational Diabetes

Kaiser Permanente·interventional·Posted Nov 9, 2016·Updated Feb 26, 2019

In Brief

A clinical study evaluating 1-Self-monitoring of blood glucose, 2-Self-weighing, and 3 other interventions for Diabetes, Gestational. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 9, 2016
Enrollment StartSep 1, 2014
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 9.6 years ago

Interventions

1-Self-monitoring of blood glucosedevice

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-weighingdevice

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 pressuredevice

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 ratedevice

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 caregiversprocedure

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