The Virtual Visit for Women With Gestational Diabetes

• Sponsor: Kaiser Permanente (Other)
• Overall Status: Completed
• CT.gov ID: NCT02960295
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes, Gestational	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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Virtual Visit for Women With Gestational Diabetes
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Virtual visit Self-monitoring of blood glucose (four times daily). Self-weighing (weekly). Self-checking of blood pressure (weekly). Checking fetal heart rate (weekly). Visits with caregivers.

Device: 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.; 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.; 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.; 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.; Procedure: 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. Glucose Concentrations [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Southern California	Pasadena	California	United States	91101

Sponsors and Collaborators

• Kaiser Permanente

Investigators

• Principal Investigator: David A Sacks, MD, Kaiser Permanente

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT02960295
• Other Study ID Numbers: 10539
• First Posted: Nov 9, 2016
• Last Update Posted: Feb 26, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Diabetes, Gestational; Diabetes Mellitus

Study Results

Participant Flow

Arm/Group Title	Virtual Visit
Arm/Group Description	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 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. 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. 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. Checking fetal
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Virtual Visit
Arm/Group Description	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 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. 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. 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. Checking fetal
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30 (1.7)
Sex: Female, Male (Count of Participants)
Female	10 100%
Male	0 0%
Sex: Female, Male (Count of Participants)
Female	10 100%
Male	0 0%
Compliance with requirements of study (Count of Participants)
Count of Participants [Participants]	10 100%

Outcome Measures

1. Primary Outcome

Title	Compliance With Requirements for Frequency of Glucose Measures
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

women with gestational diabetes

Arm/Group Title	Virtual Visit
Arm/Group Description	all participants
Measure Participants	10
Mean (Standard Deviation) [number of glucose checks per pt per day]	3.1 (1.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Virtual Visit
	Comments	In this interventional study the number of glucose checks per patient per day was calculated as stated above. There was no comparison group and no test of statistical significance.
	Type of Statistical Test	Other
	Comments	There was no comparison group and no test of statistical significance.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		This is a simple calculation of the mean (sd) of the number of glucose checks per pt per day

2. Secondary Outcome

Title	Compliance With Self-weighing Requirements
Description	Average percentage of weight checks per week in study, calculated as total weight checks in study/weeks in study x 100
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Women with gestational diabetes

Arm/Group Title	Virtual Visit
Arm/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. 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. 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
Measure Participants	10
Mean (Standard Deviation) [percentage of weekly weights performed]	136 (76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Virtual Visit
	Comments
	Type of Statistical Test	Other
	Comments	This is an observational study
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Pearson correlation (r)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Virtual Visit
	Comments
	Type of Statistical Test	Other
	Comments	This is an observational study
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Pearson correlation coefficient (r)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Virtual Visit
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Pearson correlation coefficient (r)
	Comments

3. Secondary Outcome

Title	Compliance With Blood Pressure Checking Requirements
Description	Percentage of required once-weekly blood pressure checks calculated as total blood pressure checks in study/weeks in study x 100
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Virtual Visit
Arm/Group Description	all participants
Measure Participants	10
Mean (Standard Deviation) [percentage of Blood Pressure checks]	162.5 (69.48)

4. Secondary Outcome

Title	Glucose Concentrations
Description	Mean of all glucose measures during study, in mg/dl
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Virtual Visit
Arm/Group Description	all participants
Measure Participants	10
Mean (Standard Deviation) [milligrams per deciliter]	106.0 (3.83)

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	Definitions used were those of clinicaltrials.gov.
Arm/Group Title	Virtual Visit
Arm/Group Description	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 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. Self-weighing: Self-weighing on electronic scale at least once a week. Self-checking of blood pressure: Self-checking of blood pressure at least weekly with sphygmomanometer. Checking fetal heart rate: Patient will record her fetus' heart rate with a Doppler device at least once weekly. Visits with caregivers: Telephone visits will alternate with in-office visits
All Cause Mortality
	Virtual Visit
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Virtual Visit
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Virtual Visit
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.