- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Cambridge, Storbritannia, CB2 0QQ
- Addenbrooke's Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Closed loop (algorithm)
Subcutaneous delivery of Novorapid insulin, dose calculated by computer-driven control algorithm, based on continuous glucose sensor readings
|
Subkutan tilførsel av Novorapid insulin, dose beregnet av kontrollalgoritme, basert på kontinuerlige glukosesensoravlesninger
|
Placebo komparator: Open loop
Subcutaneous delivery of Novorapid insulin according to usual pump regime
|
Subkutan tilførsel av Novorapid insulin i henhold til vanlig pumperegime
|
Hva måler studien?
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Mark L Evans, MD FRCP, University of Cambridge, UK
- Studieleder: Roman Hovorka, PhD, University of Cambridge, UK
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 09/H0306/44
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