Pregnancy Remote Monitoring of Women at Risk for Gestational Diabetes
Primary Purpose
Pregnancy Diabetic
Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
iHealth Align
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy Diabetic
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
Sites / Locations
- Ziekenhuis Oost-Limburg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Remote monitoring group
Arm Description
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.
Outcomes
Primary Outcome Measures
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?
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?
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?
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?
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?
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03491436
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No patient enrolled
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Diabetic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Women (at risk of) GDM will be included in this study. They receive a iHealth Align (a glucose monitor) and associated glycemiestrips.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote monitoring group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
iHealth Align
Intervention Description
remote monitor glucometer
Primary Outcome Measure Information:
Title
Blood glucose sober
Description
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?
Time Frame
an average of 30 weeks
Title
Weight once a day
Description
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?
Time Frame
an average of 30 weeks
Title
blood glucose 2 hours after meal 1
Description
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?
Time Frame
an average of 30 weeks
Title
blood glucose 2 hours after meal 2
Description
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?
Time Frame
through study completion
Title
blood glucose 2 hours after meal 3
Description
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?
Time Frame
an average of 30 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried Gyselaers, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pregnancy Remote Monitoring of Women at Risk for Gestational Diabetes
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