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- Klinische proef NCT00944619
Closing the Loop in Adults With Type 1 Diabetes - Alcohol Consumption (ANGELA02)
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Cambridge, Verenigd Koninkrijk, CB2 0QQ
- Addenbrooke's Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Closed loop (algorithm)
Subcutaneous delivery of Novorapid insulin, dose calculated by computer-driven control algorithm, based on continuous glucose sensor readings
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Subcutane toediening van Novorapid-insuline, dosis berekend door controle-algoritme, gebaseerd op continue glucosesensormetingen
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Placebo-vergelijker: Open loop
Subcutaneous delivery of Novorapid insulin according to usual pump regime
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Subcutane toediening van Novorapid-insuline volgens het gebruikelijke pompregime
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Percentage of plasma glucose values in target (3.9-8.0 mmol/L)
Tijdsspanne: 2200-1200hr
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2200-1200hr
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
|
|
Percentage of plasma glucose and CGM values above 8.0 mmol/L
Tijdsspanne: 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
Tijdsspanne: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
|
2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
|
|
Average plasma insulin concentration
Tijdsspanne: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
|
2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
|
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Total dose of insulin administered
Tijdsspanne: 2200-1200hrs
|
2200-1200hrs
|
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Low blood glucose index (LBGI) score
Tijdsspanne: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
|
2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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High blood glucose index (HBGI) score
Tijdsspanne: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Percentage of plasma glucose and CGM values below 3.0 mmol/L
Tijdsspanne: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
|
2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mark L Evans, MD FRCP, University of Cambridge, UK
- Studie directeur: Roman Hovorka, PhD, University of Cambridge, UK
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 09/H0306/44
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