NCT03491436

Pregnancy Remote Monitoring of Women at Risk for Gestational Diabetes

Withdrawn NA Last updated 9 April 2018

What this trial tests

NA trial testing iHealth Align in Pregnancy Diabetic. Withdrawn.

Timeline

1 May 2017

Primary endpoint
31 December 2017

31 December 2017

Quick facts

Lead sponsor	Hasselt University
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Start date	1 May 2017
Primary completion	31 December 2017
Estimated completion	31 December 2017
Sites	1 location across Belgium

Drugs / interventions tested

• iHealth Align

Conditions studied

• Pregnancy Diabetic — all drugs for Pregnancy Diabetic →

Sponsor

Hasselt University

Who can join

18 and older, female only, with Pregnancy Diabetic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.