Pregnancy Remote Monitoring of Women at Risk for Gestational Diabetes

Pregnancy Diabetic Clinical Trial

Official title:

Pregnancy Remote Monitoring of Women at Risk for Gestational Diabetes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03491436
• Other study ID #: PRM-001
• Status: Withdrawn
• Phase: N/A
• First received: August 8, 2017
• Last updated: April 6, 2018
• Start date: May 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2018
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Pregnancy Diabetic
• Pregnancy in Diabetics

Intervention

Device:
• iHealth Align
remote monitor glucometer

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose sober	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.; Has both mother and child advantages when the mother is screened and provided with the remote monitoring devices? is RM acceptable to use in the prenatal care for GDM and does it have in added value in gestational outcomes?	an average of 30 weeks
Primary	Weight once a day	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.; Has both mother and child advantages when the mother is screened and provided with the remote monitoring devices? is RM acceptable to use in the prenatal care for GDM and does it have in added value in gestational outcomes?	an average of 30 weeks
Primary	blood glucose 2 hours after meal 1	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.; Has both mother and child advantages when the mother is screened and provided with the remote monitoring devices? is RM acceptable to use in the prenatal care for GDM and does it have in added value in gestational outcomes?	an average of 30 weeks
Primary	blood glucose 2 hours after meal 2	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.; Has both mother and child advantages when the mother is screened and provided with the remote monitoring devices? is RM acceptable to use in the prenatal care for GDM and does it have in added value in gestational outcomes?	through study completion
Primary	blood glucose 2 hours after meal 3	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.; Has both mother and child advantages when the mother is screened and provided with the remote monitoring devices? is RM acceptable to use in the prenatal care for GDM and does it have in added value in gestational outcomes?	an average of 30 weeks