NCT01359241

Achieving Normal Glucose In Hospital Settings

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Cambridge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Dysglycaemia

Interventions

Type	Name	Description
PROCEDURE	closed-loop insulin delivery	Insulin delivery via subcutaneous pump, adjusted according to computer-based algorithm advice, based on continuous glucose sensor readings
DRUG	Usual diabetes treatment regimen	Usual non-insulin glucose lowering medications

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-05-24
• Last updated: 2012-11-12

Locations

1 site across 1 country: United Kingdom