Clinical trial NCT03491436: Pregnancy Remote Monitoring of Women at Risk for Gestational Diabetes
Official title: Pregnancy Remote Monitoring of Women at Risk for Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pregnancy Diabetic
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Women (at risk of) GDM will be included in this study. They receive a iHealth Align (a glucose monitor) and associated glycemiestrips.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* women with confirmed GDM or at risk for this disease. Pregnancies \> 10 weeks of gestation, primipara and multipara.

Exclusion Criteria:

* pregnancies \< 10 weeks of gestation, congenital malformations of the fetus

Primary outcomes:
measure: Blood glucose sober
timeFrame: an average of 30 weeks
measure: Weight once a day
timeFrame: an average of 30 weeks
measure: blood glucose 2 hours after meal 1
timeFrame: an average of 30 weeks
measure: blood glucose 2 hours after meal 2
timeFrame: through study completion
measure: blood glucose 2 hours after meal 3
timeFrame: an average of 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Hasselt University
name: Wilfried Gyselaers, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: