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Pregnancy Remote Monitoring of Women at Risk for Gestational Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491436
Recruitment Status : Withdrawn (No patient enrolled)
First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Wilfried Gyselaers, Hasselt University

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.


Condition or disease Intervention/treatment Phase
Pregnancy Diabetic Device: iHealth Align Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pregnancy Remote Monitoring of Women at Risk for Gestational Diabetes
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Remote monitoring group
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.
Device: iHealth Align
remote monitor glucometer




Primary Outcome Measures :
  1. Blood glucose sober [ Time Frame: an average of 30 weeks ]

    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?


  2. Weight once a day [ Time Frame: an average of 30 weeks ]

    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?


  3. blood glucose 2 hours after meal 1 [ Time Frame: an average of 30 weeks ]

    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?


  4. blood glucose 2 hours after meal 2 [ Time Frame: through study completion ]

    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?


  5. blood glucose 2 hours after meal 3 [ Time Frame: an average of 30 weeks ]

    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?




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491436


Locations
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Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Sponsors and Collaborators
Hasselt University
Investigators
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Principal Investigator: Wilfried Gyselaers, prof. dr. Hasselt University

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Responsible Party: Wilfried Gyselaers, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT03491436    
Other Study ID Numbers: PRM-001
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases