Clinical trial NCT02960295: The Virtual Visit for Women With Gestational Diabetes
Official title: The Virtual Visit for Women With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes, Gestational
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compliance With Requirements for Frequency of Glucose Measures
timeFrame: 1 year
Secondary outcomes:
measure: Compliance With Self-weighing Requirements
timeFrame: 1 year
measure: Compliance With Blood Pressure Checking Requirements
timeFrame: 1 year
measure: Glucose Concentrations
timeFrame: 1 year
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente Southern California
state: California
Study officials:
affiliation: Kaiser Permanente
name: David A Sacks, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.