Closing the Loop in Adults With Type 1 Diabetes (ANGELA01)

This study has been completed.
Sponsor:
Collaborators:
Cambridge University Hospitals NHS Foundation Trust
Diabetes UK
Information provided by:
University of Cambridge
ClinicalTrials.gov Identifier:
NCT00910767
First received: May 28, 2009
Last updated: September 16, 2009
Last verified: September 2009
  Purpose

The main objective of this study is to evaluate the feasibility of closed loop insulin pump therapy to improve overnight glucose control in adults with type 1 diabetes.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, 2-period Cross-over Study to Assess the Feasibility of Overnight Computer-based Glucose Control Based on Continuous Subcutaneous Glucose Monitoring, and Compare it With Conventional Pump Therapy in Adults With Type 1 Diabetes

Resource links provided by NLM:


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: 1900 to 0800hr ] [ 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: 1900 to 0800hr ] [ Designated as safety issue: No ]
  • Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L) [ Time Frame: 0000 to 0800hr ] [ Designated as safety issue: No ]
  • Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L) [ Time Frame: 0800 to 1200hr ] [ Designated as safety issue: No ]
  • Percentage of plasma glucose and CGM values below 3.9 mmol/L [ Time Frame: 1900 to 0800hr ] [ Designated as safety issue: No ]
  • Percentage of plasma glucose and CGM values below 3.9 mmol/L [ Time Frame: 0000 to 0800hr ] [ Designated as safety issue: No ]
  • Percentage of plasma glucose and CGM values below 3.9 mmol/L [ Time Frame: 0800 to 1200hr ] [ Designated as safety issue: No ]
  • Percentage of plasma glucose and CGM values above 8.0 mmol/L [ Time Frame: 1900 to 0800hr ] [ Designated as safety issue: No ]
  • Percentage of plasma glucose and CGM values above 8.0 mmol/L [ Time Frame: 0000 to 0800hr ] [ Designated as safety issue: No ]
  • Percentage of plasma glucose and CGM values above 8.0 mmol/L [ Time Frame: 0800 to 1200hr ] [ Designated as safety issue: No ]
  • Average plasma and CGM glucose [ Time Frame: 1900 to 0800hr ] [ Designated as safety issue: No ]
  • Average plasma and CGM glucose [ Time Frame: 0000 to 0800hr ] [ Designated as safety issue: No ]
  • Average plasma and CGM glucose [ Time Frame: 0800 to 1200hr ] [ Designated as safety issue: No ]
  • Average plasma insulin concentration [ Time Frame: 1900 to 0800hr ] [ Designated as safety issue: No ]
  • Average plasma insulin concentration [ Time Frame: 0000 to 0800hr ] [ Designated as safety issue: No ]
  • Average plasma insulin concentration [ Time Frame: 0800 to 1200hr ] [ Designated as safety issue: No ]
  • Total dose of insulin administered [ Time Frame: 1900 to 0800hr ] [ Designated as safety issue: No ]
  • low blood glucose index (LBGI) score [ Time Frame: 1900 to 0800hr ] [ Designated as safety issue: No ]
  • high blood glucose index (HBGI) score [ Time Frame: 1900 to 0800hr ] [ Designated as safety issue: No ]
  • low blood glucose index (LBGI) score [ Time Frame: 0000 to 0800hr ] [ Designated as safety issue: No ]
  • low blood glucose index (LBGI) score [ Time Frame: 0800 to 1200hr ] [ Designated as safety issue: No ]
  • high blood glucose index (HBGI) score [ Time Frame: 0000 to 0800hr ] [ Designated as safety issue: No ]
  • high blood glucose index (HBGI) score [ Time Frame: 0800 to 1200hr ] [ Designated as safety issue: No ]
  • Percentage of plasma glucose and CGM values below 3.0 mmol/L [ Time Frame: 1900 to 0800hr ] [ Designated as safety issue: Yes ]
  • Percentage of plasma glucose and CGM values below 3.0 mmol/L [ Time Frame: 0000 to 0800hr ] [ Designated as safety issue: Yes ]
  • Percentage of plasma glucose and CGM values below 3.0 mmol/L [ Time Frame: 0800 to 1200hr ] [ Designated as safety issue: Yes ]

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

Detailed Description:

People with type 1 diabetes(T1D) need regular insulin injections or continuous delivery of insulin using an insulin pump in order to keep the blood glucose levels normal. We know that keeping blood sugars in the normal range will help prevent long term diabetes related 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). This is a particular problem at night and one solution is to develop a system whereby the amount of insulin injected is very closely matched to the blood sugar levels on a continuous basis. This can be achieved by what is called a "closed loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives an insulin pump. This system is being developed in Cambridge and we have trialed this on 16 children and adolescents with T1D in a clinical setting over the past year. We have found that this system is very effective at preventing hypoglycaemia in this group of patients.

We will recruit 12 adults with T1D on insulin pump therapy, and the studies will be done in a clinical research facility. The subjects will be studied on two nights. On one night they will have their normal insulin pump therapy and on the other night their insulin pump will be varied according to information about blood glucose values from the continuous glucose sensor. This information will be manually typed into the computer every 15 minutes from 8pm until 8am. The algorithm will advise of the insulin infusion rate and this will be manually changed by a trained nurse every 15 minutes throughout the night.

  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 the results
  • Known/suspected allergy against insulin
  • Patients with clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
  • Ongoing severe recurrent hypoglycaemia as judged by the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910767

Locations
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Sponsors and Collaborators
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Diabetes UK
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: NCT00910767     History of Changes
Other Study ID Numbers: 08/H0308/297
Study First Received: May 28, 2009
Last Updated: September 16, 2009
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
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 October 02, 2014