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

18. januar 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

4424

Kontakter og plasseringer

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

Studiesteder

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

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

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Patients with diabetes (type 1 and 2)
Legemiddel: insulin
Patients will be asked to complete 2 self-assessment questionnaires

Hva måler studien?

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

Samarbeidspartnere og etterforskere

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

Sponsor

Novo Nordisk A/S

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

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

1. mai 2012

Primær fullføring (Faktiske)

1. september 2012

Studiet fullført (Faktiske)

1. september 2012

Datoer for studieregistrering

Først innsendt

22. juni 2012

Først innsendt som oppfylte QC-kriteriene

25. juni 2012

Først lagt ut (Anslag)

26. juni 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

19. januar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. januar 2017

Sist bekreftet

1. januar 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

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. .

Kliniske studier på Diabetes mellitus, type 2

Kliniske studier på insulin

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

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CROs in Cameroon

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

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Sponsor / samarbeidspartnere

Steder

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