Smartphone Application for the Management of Gestational Diabetes Mellitus
10. februar 2019 opdateret af: Cheol-Young Park, Kangbuk Samsung Hospital
Peripartum Management of Gestational Diabetes Using a Digital Healthcare Service: a Pilot, Randomized Controlled Study
The prevalence of gestational diabetes mellitus (GDM) has been progressively increasing.
It is important to recognize and treat GDM to minimize the risk of maternal and neonatal complications.
Multifaceted professional interventions are effective in the management of GDM and mobile healthcare can be an effective approach.
The purpose of the current study was to develop and evaluate a model for prevention and management of GDM using mobile healthcare.
Subjects with no previous history of diabetes, who were diagnosed with GDM during 24-28 weeks of gestation, were randomly divided into a conventional management group and a mobile management group.
The conventional mangement group received conventional GDM management and could freely use the mobile healthcare application.
The mobile management group received mobile healthcare services including tailored mobile coaching.
The effectiveness of the management using the application were evaluated through the result values of the laboratory tests, anthropometric measurement performed during the study period and perinatal outcomes.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
21
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Seoul, Korea, Republikken
- Kangbuk Samsung Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
19 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Singleton pregnant women diagnosed as GDM at 24 to 28 weeks of gestation were included.
Exclusion Criteria:
- Patients after 30th week of gestation and patients with pregestational diabetes were excluded from participating in the study. Patients who were unable to understand Korean, were unfamiliar with mobile phones, who did not have access to a mobile phone, or who were already receiving services from another mobile healthcare agency were also excluded.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: conventional management group
The conventional management group received standard GDM management and could freely use the smartphone healthcare application.
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Eksperimentel: mobile management group
The mobile management group received mobile healthcare services through smartphone application specifically developed for this trial including tailored mobile coaching.
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Mobile management group participants were given monitoring system devices including a glucometer with Bluetooth connectivity and an accelerometer to detect physical activity level.
The mobile phone application specifically designed for this study was installed at enrollment for the mobile management group to collect clinical data and messages from the patients.
The application consisted of four sections: clinical data, nutrition and diet, medication, and messaging system and information.
Patients allocated to the mobile management group recorded their blood glucose level and diet via the smartphone application, and health care providers regularly scanned clinical data and messages from patients and sent return messages with tailored medical and nutritional guidance.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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hemoglobin A1c levels
Tidsramme: up to 4 to 12weeks after delivery
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serum glycated hemoglobin levels
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up to 4 to 12weeks after delivery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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body weight
Tidsramme: up to 4 to 12weeks after delivery
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the changes in body weight
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up to 4 to 12weeks after delivery
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body mass index
Tidsramme: up to 4 to 12weeks after delivery
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the changes in body mass index
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up to 4 to 12weeks after delivery
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percent body fat
Tidsramme: up to 4 to 12weeks after delivery
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the changes in percent body fat
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up to 4 to 12weeks after delivery
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HOMA IR(homeostatic model assessment insulin resistance)
Tidsramme: up to 4 to 12weeks after delivery
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the changes in insulin resistance
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up to 4 to 12weeks after delivery
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HOMA-ß (homeostatic model assessment ß-cell dysfunction )
Tidsramme: up to 4 to 12weeks after delivery
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the changes in ß-cell dysfunction
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up to 4 to 12weeks after delivery
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Neonate large for gestational age
Tidsramme: at the day of delivery
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Birth weight of neonates of GDM patients
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at the day of delivery
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Mode of delivery
Tidsramme: at the day of delivery
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Rate of cesarean section
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at the day of delivery
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. februar 2017
Primær færdiggørelse (Faktiske)
31. august 2017
Studieafslutning (Faktiske)
31. oktober 2017
Datoer for studieregistrering
Først indsendt
8. februar 2019
Først indsendt, der opfyldte QC-kriterier
10. februar 2019
Først opslået (Faktiske)
12. februar 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. februar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. februar 2019
Sidst verificeret
1. februar 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KBSMC2016-11-049
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