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

This study has been completed.
Sponsor:
Collaborator:
Cambridge University Hospitals NHS Foundation Trust
Information provided by:
University of Cambridge
ClinicalTrials.gov Identifier:
NCT00944619
First received: July 21, 2009
Last updated: May 10, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention
Type 1 Diabetes
 Device: Closed loop
Device: Conventional insulin pump delivery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cambridge:

Primary Outcome Measures:
  • Percentage of plasma glucose values in target (3.9-8.0 mmol/L) [ Time Frame: 2200-1200hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L) [ Time Frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs ] [ Designated as safety issue: No ]
  • Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L) [ Time Frame: 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs ] [ Designated as safety issue: No ]
  • Percentage of plasma glucose and CGM values below 3.9 mmol/L [ Time Frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs ] [ Designated as safety issue: No ]
  • Percentage of plasma glucose and CGM values above 8.0 mmol/L [ Time Frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs ] [ Designated as safety issue: No ]
  • Average plasma and CGM glucose [ Time Frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs ] [ Designated as safety issue: No ]
  • Average plasma insulin concentration [ Time Frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs ] [ Designated as safety issue: No ]
  • Total dose of insulin administered [ Time Frame: 2200-1200hrs ] [ Designated as safety issue: No ]
  • Low blood glucose index (LBGI) score [ Time Frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs ] [ Designated as safety issue: No ]
  • High blood glucose index (HBGI) score [ Time Frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs ] [ Designated as safety issue: No ]
  • Percentage of plasma glucose and CGM values below 3.0 mmol/L [ Time Frame: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Closed loop (algorithm)
Subcutaneous delivery of Novorapid insulin, dose calculated by computer-driven control algorithm, based on continuous glucose sensor readings
 Device: Closed loop
Subcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings
Placebo Comparator: Open loop
Subcutaneous delivery of Novorapid insulin according to usual pump regime
 Device: Conventional insulin pump delivery
Subcutaneous delivery of Novorapid insulin according to usual pump regime

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944619

Locations
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Sponsors and Collaborators
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Mark L Evans, MD FRCP University of Cambridge, UK
Study Director: Roman Hovorka, PhD University of Cambridge, UK
  More Information

No publications provided by University of Cambridge

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Mark Evans, University of Cambridge
ClinicalTrials.gov Identifier: NCT00944619     History of Changes
Other Study ID Numbers: 09/H0306/44
Study First Received: July 21, 2009
Last Updated: May 10, 2010
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013