Achieving Normal Glucose In Hospital Settings (Angie01)

An Open-label, Single-centre, Randomised, Two-period Crossover Study to Assess the Efficacy and Safety of 24-hour Closed-loop Glucose Control in Comparison With Conventional Treatment in Adults With Type 2 Diabetes on Non-insulin Glucose-lowering Agents

The main objective of this study is to evaluate the efficacy and safety of 24 hours of closed-loop glucose control compared with standard diabetes treatment, in patients with type 2 diabetes treated by non-insulin glucose-lowering medications. This group is being studied as it is representative of patients with glucose dysregulation.

Study Overview

• Status: Completed
• Conditions: Dysglycaemia
• Intervention / Treatment: Procedure: closed-loop insulin delivery; Drug: Usual diabetes treatment regimen

Detailed Description

Algorithm driven closed-loop enables automated subcutaneous delivery of insulin in response to real-time continuous glucose sensor readings. Our studies to date have assessed the safety and efficacy of closed-loop insulin delivery in patients with type 1 diabetes in a controlled setting. For patients with type 2 diabetes treated by diet or non-insulin glucose-lowering medications alone, an episode of acute illness may result in elevated glucose levels necessitating initiation of insulin replacement therapy to optimise glycaemic control. Insulin may also be required in patients with no prior history of diabetes, presenting with 'stress hyperglycaemia'. Closed-loop systems may be of benefit in such insulin-naive patients in whom the optimal dosing regimen is difficult to establish, and may provide a safer method of insulin delivery with the added benefit of continuous monitoring of glucose levels on general hospital wards, thus minimising the likelihood of hyper- and hypoglycaemic events and their known associated worse outcomes.

The study has an open-label, randomised, two-period crossover design. Participants will be randomised to undergo two 24-hour studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm (intervention) or by patients' usual non-insulin glucose-lowering diabetes treatment regimen (control). A continuous glucose sensor will be inserted on arrival for each visit. Participants will consume regular meals (matched on both visits) and carry out daily activities mimicking those occurring in an inpatient setting. Stable glucose isotopes will be administered on the two study occasions to collect data for modeling of glucose turnover around meals and during the overnight period.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB20QQ
    • Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 18 years or older
• Type 2 diabetes for at least 1 year as defined by WHO
• Treatment with glucose-lowering medication(s) (including Exenatide) for at least 6 mths
• HbA1c between 7.0% and 10.0% inclusive (measured within past 3 mths)

Exclusion Criteria:

• Autoimmune type 1 diabetes
• Type 2 diabetes treated with insulin
• Type 2 diabetes treated with diet control alone
• Known or suspected allergy against insulin
• Proliferative retinopathy
• Current or planned pregnancy or breast feeding
• Any physical or psychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by the study clinician

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: closed-loop insulin delivery; Subcutaneous insulin delivery adjusted according to computer-based algorithm advice, based on continuous glucose sensor readings	Procedure: closed-loop insulin delivery; Insulin delivery via subcutaneous pump, adjusted according to computer-based algorithm advice, based on continuous glucose sensor readings
Active Comparator: Usual diabetes treatment regimen; Usual non-insulin glucose-lowering medications	Drug: Usual diabetes treatment regimen; Usual non-insulin glucose lowering medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent of plasma glucose values within target range 3.9-8.0 mmol/l	24 hrs

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent of sensor glucose values within target range 3.9-8.0 mmol/l	24 hrs
Percent of plasma and sensor glucose values below 3.9 mmol/l	24 hrs
Percent of plasma and sensor glucose values above 8.0 mmol/l	24 hrs
Mean plasma and sensor glucose	24 hrs
Mean plasma insulin concentration	24 hrs
Total basal insulin insulin delivery	24 hrs
Low blood glucose index (LBGI) score	24 hrs
High blood glucose index (HBGI) score	24 hrs
Hyperglycaemic index score	24 hrs
Percent of plasma and sensor glucose values below 3.0 mmol/l	24 hrs
Standard deviation of plasma glucose	24 hrs
Frequency of hypoglycaemia	24 hrs
Frequency of hyperglycaemia	24 hrs

Collaborators and Investigators

• Sponsor: University of Cambridge
• Collaborators: Cambridge University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Roman Hovorka, PhD, University of Cambridge

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: May 19, 2011
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (Estimate): May 24, 2011

Study Record Updates

• Last Update Posted (Estimate): November 12, 2012
• Last Update Submitted That Met QC Criteria: November 9, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: diabetes; dysglycemia; closed loop insulin delivery
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: A092232