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French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients (DIALOG)

18. januar 2017 opdateret af: Novo Nordisk A/S

This non-interventional study is conducted in Europe. The study is both retrospective and prospective.

The purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in insulin-treated patients with type 1 and type 2 diabetes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

4424

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Paris La défense cedex, Frankrig, 92932
        • Novo Nordisk Investigational Site

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Approximately 3811 patients with Type 1 or Type 2 diabetes are expected to be recruited. Patients will be asked to complete 2 self-assessment questionnaires, one retrospective and one prospective, to characterize severe hypoglycaemias during the last 12 months (retrospective questionnaire) and severe/non-severe hypoglycaemias during the coming month after inclusion (prospective questionnaire).

Beskrivelse

Inclusion Criteria:

  • Patients with Type 1 or Type 2 Diabetes Mellitus
  • Patients treated by insulin for at least 12 months
  • Patients able to perform capillary self-monitoring plasma glucose (SMPG) measurements
  • Patients able to complete the questionnaires
  • Patients who have accepted to participate to the survey (signature of an information notice)

Exclusion Criteria:

  • Patients with Type 2 Diabetes Mellitus not treated with insulin
  • Females who are currently pregnant or lactating or who were pregnant during the previous year

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patients with diabetes (type 1 and 2)
Medicin: insulin
Patients will be asked to complete 2 self-assessment questionnaires

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Percentage of insulin-treated patients experiencing at least one hypoglycaemia (severe/non-severe)
Tidsramme: During the one-month follow-up after inclusion in study
During the one-month follow-up after inclusion in study

Sekundære resultatmål

Resultatmål
Tidsramme
Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia
Tidsramme: During the last 12 months before inclusion in study
During the last 12 months before inclusion in study
Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia
Tidsramme: During the one-month follow-up after inclusion in study
During the one-month follow-up after inclusion in study
Percentage of insulin-treated patients experiencing at least one non-severe symptomatic hypoglycaemia
Tidsramme: During the one-month follow-up after inclusion in study
During the one-month follow-up after inclusion in study
Percentage of insulin-treated patients experiencing at least one asymptomatic hypoglycaemia
Tidsramme: During the one-month follow-up after inclusion in study
During the one-month follow-up after inclusion in study
Percentage of insulin-treated patients experiencing at least one hypoglycaemia (overall/severe/non-severe)
Tidsramme: During the one-month follow-up after inclusion in study
During the one-month follow-up after inclusion in study
Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia
Tidsramme: During the last 12 months before inclusion in study
During the last 12 months before inclusion in study
Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia
Tidsramme: During the one-month follow-up after inclusion in study
During the one-month follow-up after inclusion in study
Rate of episodes (event/patient/month) in insulin-treated patients of non-severe symptomatic hypoglycaemia episodes
Tidsramme: During the one-month follow-up after inclusion in study
During the one-month follow-up after inclusion in study
Rate of episodes (event/patient/month) in insulin-treated patients of asymptomatic hypoglycaemia episodes
Tidsramme: During the one-month follow-up after inclusion in study
During the one-month follow-up after inclusion in study
Overall/severe/non-severe hypoglycaemia episodes (event/patient/month)
Tidsramme: During the one-month follow-up after inclusion in study
During the one-month follow-up after inclusion in study
Extra diagnostic tests carried out (number of extra self-monitoring plasma glucose (SMPG) test following the episode)
Tidsramme: During the one-month follow-up after inclusion in study
During the one-month follow-up after inclusion in study
Additional consultations to a specialist and/or general practitioner (GP), visit to emergency department, hospitalizations, transportation and assistance of a care-giver
Tidsramme: During the one-month follow-up after inclusion in study
During the one-month follow-up after inclusion in study
Change in planned daily activities; sleep, food consumption, physical activities (sport), driving, social life
Tidsramme: During the one-month follow-up after inclusion in study
During the one-month follow-up after inclusion in study
Change in planned daily activities; work: effectiveness, missing hours or days for sick leave
Tidsramme: During the one-month follow-up after inclusion in study
During the one-month follow-up after inclusion in study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novo Nordisk A/S

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.

Generelle publikationer

Hjælpsomme links

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

1. maj 2012

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. september 2012

Datoer for studieregistrering

Først indsendt

22. juni 2012

Først indsendt, der opfyldte QC-kriterier

25. juni 2012

Først opslået (Skøn)

26. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • INS-3988
  • U1111-1131-8540 (Anden identifikator: WHO)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes mellitus, type 2

Kliniske forsøg med insulin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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