Trial Outcomes & Findings for The Virtual Visit for Women With Gestational Diabetes (NCT NCT02960295)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

1 year

Results posted on

2019-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	Virtual Visit Pregnant women with gestational diabetes (GDM) who will: 1-self-monitor blood glucose 4 times daily, 2-self-weigh themselves weekly, 3-self-check their blood pressure weekly, 4-check their fetus' heart rate weekly, and 5-alternate office visits with telephone visits with their caregivers 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. 2. Self-weighing: Self-weighing on electronic scale at least once a week. Results will be transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment. 3. Self-checking of blood pressure: Self-checking of blood pressure at least weekly with sphygmomanometer. Results will be transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment. 4. Checking fetal
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Virtual Visit for Women With Gestational Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Visit n=10 Participants Pregnant women with GDM who will: 1-self-monitor blood glucose four times daily, 2-self-weigh themselves weekly, 3-self-check their blood pressure weekly, 4-check their fetus' heart rate weekly, and 5-alternate office visits with telephone visits with their caregivers 1. Self-monitoring of blood glucose: Self-monitoring of blood glucose 4 times daily: Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment. 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. 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. 4. Checking fetal
Age, Continuous	30 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Compliance with requirements of study	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: women with gestational diabetes

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.

Outcome measures

Outcome measures
Measure	Virtual Visit n=10 Participants all participants
Compliance With Requirements for Frequency of Glucose Measures	3.1 number of glucose checks per pt per day Standard Deviation 1.26

SECONDARY outcome

Timeframe: 1 year

Population: Women with gestational diabetes

Average percentage of weight checks per week in study, calculated as total weight checks in study/weeks in study x 100

Outcome measures

Outcome measures
Measure	Virtual Visit n=10 Participants all participants
Compliance With Self-weighing Requirements	136 percentage of weekly weights performed Standard Deviation 76

SECONDARY outcome

Timeframe: 1 year

Population: Percentage of required once-weekly blood pressure checks calculated as total blood pressure checks in study/weeks in study x 100

Percentage of required once-weekly blood pressure checks calculated as total blood pressure checks in study/weeks in study x 100

Outcome measures

Outcome measures
Measure	Virtual Visit n=10 Participants all participants
Compliance With Blood Pressure Checking Requirements	162.5 percentage of Blood Pressure checks Standard Deviation 69.48

SECONDARY outcome

Timeframe: 1 year

Population: Mean of all glucose measures during study, in mg/dl

Mean of all glucose measures during study, in mg/dl

Outcome measures

Outcome measures
Measure	Virtual Visit n=10 Participants all participants
Glucose Concentrations	106.0 milligrams per deciliter Standard Deviation 3.83

Adverse Events

Virtual Visit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven Jacobsen MD, PhD. Director, Department of Research and Evaluation

Kaiser Permanente Southern California

Phone: 626-564-3470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place