N/A
N=10
The Virtual Visit for Women With Gestational Diabetes
Diabetes, Gestational
Bottom Line
View on ClinicalTrials.gov: NCT02960295 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Compliance With Requirements for Frequency of Glucose Measures — 3.1 number of glucose checks per pt per day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 1-Self-monitoring of blood glucose (Device); 2-Self-weighing (Device); 3-Self-checking of blood pressure (Device); 4-Checking fetal heart rate (Device); 5-Visits with caregivers (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Kaiser Permanente
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compliance With Requirements for Frequency of Glucose Measures |
3.1 | — |
| SECONDARY Compliance With Self-weighing Requirements |
136 | <0.05 sig |
| SECONDARY Compliance With Blood Pressure Checking Requirements |
162.5 | — |
| SECONDARY Glucose Concentrations |
106.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02960295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.