The Virtual Visit for Women With Gestational Diabetes

NCT02960295 | Completed Results

• 1 other identifier: 10539
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes, Gestational

Outcome Measures

Primary Outcomes (1)

• Compliance With Requirements for Frequency of Glucose Measures

  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.

  1 year

Secondary Outcomes (3)

• Compliance With Self-weighing Requirements

  1 year

• Compliance With Blood Pressure Checking Requirements

  1 year

• Glucose Concentrations

  1 year

Study Arms (1)

Virtual visit

EXPERIMENTAL

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.

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

Interventions

1-Self-monitoring of blood glucose 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.

Virtual visit

2-Self-weighing 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.

Virtual visit

3-Self-checking of blood pressure 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.

Virtual visit

4-Checking fetal heart rate 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.

Virtual visit

5-Visits with caregivers PROCEDURE

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

Virtual visit

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women meeting inclusion and exclusion criteria (see below) who volunteer to participate for the study. Volunteers will be solicited sequentially.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of gestational diabetes
• Singleton pregnancy
• \<32 weeks gestation
• Age 18-45 years
• Fluent and literate in English or Spanish
• Have a cellphone with capability of internet access.

You may not qualify if:

• Multiple gestations (twins or higher)
• Have a history of fetal demise
• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

Location

Related Publications (3)

• Given JE, Bunting BP, O'Kane MJ, Dunne F, Coates VE. Tele-Mum: A Feasibility Study for a Randomized Controlled Trial Exploring the Potential for Telemedicine in the Diabetes Care of Those with Gestational Diabetes. Diabetes Technol Ther. 2015 Dec;17(12):880-8. doi: 10.1089/dia.2015.0147. Epub 2015 Sep 22.

  PMID: 26394017 RESULT

• Homko CJ, Deeb LC, Rohrbacher K, Mulla W, Mastrogiannis D, Gaughan J, Santamore WP, Bove AA. Impact of a telemedicine system with automated reminders on outcomes in women with gestational diabetes mellitus. Diabetes Technol Ther. 2012 Jul;14(7):624-9. doi: 10.1089/dia.2012.0010. Epub 2012 Apr 18.

  PMID: 22512287 RESULT

• Sacks DA, Ling Grant D, Macias M, Li X, Lawrence JM. The Virtual Office Visit for Women With Gestational Diabetes Mellitus. Diabetes Care. 2017 Mar;40(3):e34-e35. doi: 10.2337/dc16-2569. Epub 2017 Jan 11. No abstract available.

  PMID: 28077459 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Steven Jacobsen MD, PhD. Director, Department of Research and Evaluation
• Organization: Kaiser Permanente Southern California

Steven.J.Jacobsen@nsmtp.kp.org

626-564-3470

Study Officials

• David A Sacks, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: November 9, 2016
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 26, 2019
• Results First Posted: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)