Closing the Loop in Adults With Type 1 Diabetes (ANGELA01)
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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 |
- Percentage of plasma glucose values in target (3.9 - 8.0 mmol/L) [ Time Frame: 1900 to 0800hr ] [ Designated as safety issue: No ]
- 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 |
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| United Kingdom | |
| Addenbrooke's Hospital | |
| Cambridge, United Kingdom, CB2 0QQ | |
| 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 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 May 19, 2013