Closing the Loop in Adults With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— ANGELA01  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910767
• Other study ID #: 08/H0308/297
• Status: Completed
• Phase: N/A
• First received: May 28, 2009
• Last updated: September 16, 2009
• Start date: February 2009
• Est. completion date: July 2009

Study information

• Verified date: September 2009
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Conventional insulin pump delivery
Subcutaneous delivery of Novorapid insulin according to usual pump regime
• Closed loop
Subcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge

Sponsors (3)

Lead Sponsor	Collaborator
University of Cambridge	Cambridge University Hospitals NHS Foundation Trust, Diabetes UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of plasma glucose values in target (3.9 - 8.0 mmol/L)		1900 to 0800hr	No
Secondary	Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L)		1900 to 0800hr	No
Secondary	Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)		0000 to 0800hr	No
Secondary	Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)		0800 to 1200hr	No
Secondary	Percentage of plasma glucose and CGM values below 3.9 mmol/L		1900 to 0800hr	No
Secondary	Percentage of plasma glucose and CGM values below 3.9 mmol/L		0000 to 0800hr	No
Secondary	Percentage of plasma glucose and CGM values below 3.9 mmol/L		0800 to 1200hr	No
Secondary	Percentage of plasma glucose and CGM values above 8.0 mmol/L		1900 to 0800hr	No
Secondary	Percentage of plasma glucose and CGM values above 8.0 mmol/L		0000 to 0800hr	No
Secondary	Percentage of plasma glucose and CGM values above 8.0 mmol/L		0800 to 1200hr	No
Secondary	Average plasma and CGM glucose		1900 to 0800hr	No
Secondary	Average plasma and CGM glucose		0000 to 0800hr	No
Secondary	Average plasma and CGM glucose		0800 to 1200hr	No
Secondary	Average plasma insulin concentration		1900 to 0800hr	No
Secondary	Average plasma insulin concentration		0000 to 0800hr	No
Secondary	Average plasma insulin concentration		0800 to 1200hr	No
Secondary	Total dose of insulin administered		1900 to 0800hr	No
Secondary	low blood glucose index (LBGI) score		1900 to 0800hr	No
Secondary	high blood glucose index (HBGI) score		1900 to 0800hr	No
Secondary	low blood glucose index (LBGI) score		0000 to 0800hr	No
Secondary	low blood glucose index (LBGI) score		0800 to 1200hr	No
Secondary	high blood glucose index (HBGI) score		0000 to 0800hr	No
Secondary	high blood glucose index (HBGI) score		0800 to 1200hr	No
Secondary	Percentage of plasma glucose and CGM values below 3.0 mmol/L		1900 to 0800hr	Yes
Secondary	Percentage of plasma glucose and CGM values below 3.0 mmol/L		0000 to 0800hr	Yes
Secondary	Percentage of plasma glucose and CGM values below 3.0 mmol/L		0800 to 1200hr	Yes