Pregnancy Diabetic Clinical Trial
Official title:
Pregnancy Remote Monitoring of Women at Risk for Gestational Diabetes
Background: Remote monitoring (RM) is a new screenings- and or diagnostic tool in healthcare.
In 2015, the PREMOM study (Pregnancy Remote Monitoring), in which patients with gestational
hypertensive diseases did received a RM prenatal follow up, has started. The first results
showed an added value of RM in the prenatal follow-up. Due to these results, a RM program for
pregnant women with gestational diabetes mellitus (GDM) will be developed and evaluated.
Protocol: Women (at risk of) GDM will be included in this study. They receive a iHealth Align
(a glucose monitor) and associated glycemiestrips. The app of iHealth will be downloaded on
the pregnant women's Smartphone to collect the data and to send them to the researcher in the
hospital.
The women is asked to perform four glycemie controls/day (sober and two hours after every
mail) with the received glucose monitor. The monitor is connected via Wi-Fi and Bluetooth
with the computer of the researches who controls and evaluated these data. Additionally, the
pregnant women has to check daily her body weight with a weight scale of her own. They have
to upload these data manually in the app on her smartphone.
When the pregnant women has an prenatal consultation, an overview with the data will be send
to the responsible gynecologist. The gynecologist will also be alarmed when the pregnant
women has three abnormal values at the same moment of the day (ex. Every morning after
breakfast). When necessary, advice among life-style can be given or a referral to an
endocrinologist can be made. The researches will not perform interventions by herself, only
the responsible doctor can do this.
By analyzing the patients parameters when she's at home, a better vision can be achieved of
the health of the mother and the child. This study will be conducted as a first research to
get a better insight in the added value of RM in pregnancies complicated with GDM.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04417452 -
Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy
|