Electronic Platform for Diabetic Patients Activation (INSULINCOM)
18. marts 2021 opdateret af: Domingo Orozco, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Efficacy of an Electronic Communication Platform to Activate Diabetic Patients Treated With Insulin
The purpose of this study is to assess the efficacy of an electronic platform for doctor-patient communication in order to reduce severe and non-severe hypoglycemia events as well as inadvertent hypoglycemia events.
Studieoversigt
Detaljeret beskrivelse
This is an open randomized clinical trial without drugs. Patients with type 2 diabetes and treated with insulin will be included. Patients allocated in the intervention group will use the electronic platform as a communication channel with their health provider during the time between visits.
The name of the platform is ti.care (https://ti.care/es) and it will be a complement of the control visits to resolve doubts through chats, email or video call. Health providers will answer the patient requests.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
106
Fase
- Ikke anvendelig
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Aged over 17 years
- Patients with type 2 diabetes diagnosis
- Patients who start insulin treatment or with intensification of treatment
- Patients who sign informed consent
Exclusion Criteria:
- Patients with type 1 diabetes diagnosis
- Life expectancy less than one year
- Pregnancy
- Patients with dementia
- Patients with treatment different to insulin
- Patients who, in the opinion of the researcher, cannot follow the recommendations of the self-care health education plan.
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 |
|---|---|
|
Ingen indgriben: Control
Usual care and usual communication with health professional
|
|
|
Eksperimentel: Intervention
They will be trained to use the ti.care platform and will be able to use it as a communication channel for any questions or clarification they require during the time elapsed between routine control visits.
This platform will be a complement to the visits, but in no case will it replace them or be used as a diagnostic or therapeutic method.
The platform does not have any treatment algorithm and only aims to facilitate communication between the patient at home and the health professional, both the doctor and the nurse educator.
It will be used in a preventive and advisory manner for the patient for follow-up.
In no case it will be used for emergencies.
Daily during working hours from Monday to Friday, health professionals will review patient requests and respond to them.
|
Electronic platform for doctor-patient communication
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from HbA1c level at 3 months
Tidsramme: Baseline and at 3 months
|
Change from HbA1c level at 3 months
|
Baseline and at 3 months
|
|
Change from basal capillary blood glucose at 3 months
Tidsramme: Baseline and at 3 months
|
Change from basal capillary blood glucose at 3 months
|
Baseline and at 3 months
|
|
Change from postprandial blood glucose at 3 months
Tidsramme: Baseline and at 3 months
|
Change from postprandial blood glucose at 3 months
|
Baseline and at 3 months
|
|
Change from nocturnal blood glucose at 3 months
Tidsramme: Baseline and at 3 months
|
Change from nocturnal blood glucose at 3 months
|
Baseline and at 3 months
|
|
Total hypoglycemia
Tidsramme: At 3 months
|
Number of total hypoglycemia events
|
At 3 months
|
|
Number of nocturnal hypoglycemia events
Tidsramme: At 3 months
|
Number of nocturnal hypoglycemia events
|
At 3 months
|
|
Number of inadvertent hypoglycemia events
Tidsramme: At 3 months
|
Number of inadvertent hypoglycemia events
|
At 3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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 (Forventet)
1. oktober 2021
Primær færdiggørelse (Forventet)
31. december 2021
Studieafslutning (Forventet)
31. maj 2022
Datoer for studieregistrering
Først indsendt
6. oktober 2020
Først indsendt, der opfyldte QC-kriterier
19. oktober 2020
Først opslået (Faktiske)
20. oktober 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2020/09
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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