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Pregnancy Remote Monitoring of Women at Risk for Gestational Diabetes

6. april 2018 oppdatert av: Wilfried Gyselaers, Hasselt University

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.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Genk, Belgia, 3600
        • Ziekenhuis Oost-Limburg

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: iHealth Align
remote monitor glucometer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Blood glucose sober
Tidsramme: 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?
an average of 30 weeks
Weight once a day
Tidsramme: 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?
an average of 30 weeks
blood glucose 2 hours after meal 1
Tidsramme: 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?
an average of 30 weeks
blood glucose 2 hours after meal 2
Tidsramme: 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?
through study completion
blood glucose 2 hours after meal 3
Tidsramme: 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?
an average of 30 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hasselt University

Etterforskere

  • Hovedetterforsker: Wilfried Gyselaers, prof. dr., Hasselt University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2017

Primær fullføring (Faktiske)

31. desember 2017

Studiet fullført (Faktiske)

31. desember 2017

Datoer for studieregistrering

Først innsendt

8. august 2017

Først innsendt som oppfylte QC-kriteriene

6. april 2018

Først lagt ut (Faktiske)

9. april 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. april 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. april 2018

Sist bekreftet

1. mars 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PRM-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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