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

Type 1 Diabetes Clinical Trial

— ANGELA02  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944619
• Other study ID #: 09/H0306/44
• Status: Completed
• Phase: N/A
• First received: July 21, 2009
• Last updated: May 10, 2010
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2009
• Est. primary completion date: December 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 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

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

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
University of Cambridge	Cambridge University Hospitals NHS Foundation Trust

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)		2200-1200hr	No
Secondary	Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L)		2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs	No
Secondary	Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)		0000-0400; 0400-0800; 0800-1200; 0300-1200hrs	No
Secondary	Percentage of plasma glucose and CGM values below 3.9 mmol/L		2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs	No
Secondary	Percentage of plasma glucose and CGM values above 8.0 mmol/L		2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs	No
Secondary	Average plasma and CGM glucose		2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs	No
Secondary	Average plasma insulin concentration		2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs	No
Secondary	Total dose of insulin administered		2200-1200hrs	No
Secondary	Low blood glucose index (LBGI) score		2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs	No
Secondary	High blood glucose index (HBGI) score		2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs	No
Secondary	Percentage of plasma glucose and CGM values below 3.0 mmol/L		2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs	Yes