Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Closing the Loop in Adults With Type 1 Diabetes - Alcohol Consumption (ANGELA02)

10. maj 2010 opdateret af: University of Cambridge

Randomised, Two-Period Crossover Study to Assess the Efficacy of Overnight Computer-based Glucose Control Compared With Conventional Pump Therapy Following the Consumption of Alcohol in Adults With Type 1 Diabetes

The main objective is to assess the efficacy and safety of overnight automated closed loop glucose control using a computer-based algorithm compared with conventional insulin pump therapy in adults with type 1 diabetes following the consumption of a moderate amount of alcohol at dinnertime.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using an insulin pump. Keeping blood sugars in the normal range is known to reduce the risk of long term complications involving the eyes, kidneys and heart. However, achieving treatment goals can be very difficult as the tighter we try to control blood glucose levels, the greater the risk of the person developing episodes of low glucose levels (hypoglycaemia). One solution is using a system where the amount of insulin injected closely matches the blood sugar levels on a continuous basis. This can be achieved by what is known as a "closed loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives a subcutaneous insulin pump. This system is being developed in Cambridge and is undergoing trials in children and adults with type 1 diabetes. Results thus far show that the system is very effective at preventing hypoglycaemia and maintaining blood glucose levels in target range.

We plan to test the closed loop in various challenging conditions faced by patients in daily life. One of these is the consumption of alcohol, which can give rise to delayed hypoglycaemia in patients with diabetes. The studies will be done in a clinical research facility under supervised conditions. Subjects will attend for two study nights where they will receive a specific volume of alcohol with an evening meal. On one night this will be followed by closed loop algorithm control of their insulin overnight. On the other (control) night subjects will remain on their usual pump therapy regime overnight.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

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 til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Type 1 diabetes, as defined by WHO for at least 6 months or confirmed C-peptide negative
  • On insulin pump therapy for at least 3 months

Exclusion Criteria:

  • Non-type 1 diabetes mellitus
  • Any physical/psychological disease likely to interfere with the study
  • Taking medication likely to interfere with interpretation of results
  • Known/suspected allergy against insulin
  • Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
  • Unstable blood glucose control, including recurrent severe hypoglycaemia as judged by the investigator
  • Current pregnancy/breastfeeding
  • Total daily insulin dose > 1.4 IU/kg
  • HbA1C > 10% within the last 3 months
  • Unable/unwilling to consume the necessary quantity of alcohol stated in the study protocol

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Closed loop (algorithm)
Subcutaneous delivery of Novorapid insulin, dose calculated by computer-driven control algorithm, based on continuous glucose sensor readings
Enhed: Lukket kredsløb
Subkutan administration af Novorapid insulin, dosis beregnet ved kontrolalgoritme, baseret på kontinuerlige glukosesensoraflæsninger
Placebo komparator: Open loop
Subcutaneous delivery of Novorapid insulin according to usual pump regime
Enhed: Konventionel insulinpumpe levering
Subkutan administration af Novorapid insulin i henhold til sædvanligt pumperegime

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Percentage of plasma glucose values in target (3.9-8.0 mmol/L)
Tidsramme: 2200-1200hr
2200-1200hr

Sekundære resultatmål

Resultatmål
Tidsramme
Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L)
Tidsramme: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)
Tidsramme: 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Percentage of plasma glucose and CGM values below 3.9 mmol/L
Tidsramme: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Percentage of plasma glucose and CGM values above 8.0 mmol/L
Tidsramme: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Average plasma and CGM glucose
Tidsramme: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Average plasma insulin concentration
Tidsramme: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Total dose of insulin administered
Tidsramme: 2200-1200hrs
2200-1200hrs
Low blood glucose index (LBGI) score
Tidsramme: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
High blood glucose index (HBGI) score
Tidsramme: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
Percentage of plasma glucose and CGM values below 3.0 mmol/L
Tidsramme: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs

Samarbejdspartnere og efterforskere

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

Sponsor

University of Cambridge

Samarbejdspartnere

Cambridge University Hospitals NHS Foundation Trust

Efterforskere

  • Ledende efterforsker: Mark L Evans, MD FRCP, University of Cambridge, UK
  • Studieleder: Roman Hovorka, PhD, University of Cambridge, UK

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

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. september 2009

Primær færdiggørelse (Faktiske)

1. december 2009

Studieafslutning (Faktiske)

1. december 2009

Datoer for studieregistrering

Først indsendt

21. juli 2009

Først indsendt, der opfyldte QC-kriterier

21. juli 2009

Først opslået (Skøn)

23. juli 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. maj 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. maj 2010

Sidst verificeret

1. januar 2010

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 09/H0306/44

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 Type 1 diabetes

Kliniske forsøg med Lukket kredsløb

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Austria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner