Clinical trial NCT01359241: Achieving Normal Glucose In Hospital Settings
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysglycaemia
Keywords: dysglycemia
diabetes
closed loop insulin delivery
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: Cambridge University Hospitals NHS Foundation Trust
First posted: 2011-05-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of plasma glucose values within target range 3.9-8.0 mmol/l
timeFrame: 24 hrs
Secondary outcomes:
measure: Percent of sensor glucose values within target range 3.9-8.0 mmol/l
timeFrame: 24 hrs
measure: Percent of plasma and sensor glucose values below 3.9 mmol/l
timeFrame: 24 hrs
measure: Percent of plasma and sensor glucose values above 8.0 mmol/l
timeFrame: 24 hrs
measure: Mean plasma and sensor glucose
timeFrame: 24 hrs
measure: Mean plasma insulin concentration
timeFrame: 24 hrs
measure: Total basal insulin insulin delivery
timeFrame: 24 hrs
measure: Low blood glucose index (LBGI) score
timeFrame: 24 hrs
measure: High blood glucose index (HBGI) score
timeFrame: 24 hrs
measure: Hyperglycaemic index score
timeFrame: 24 hrs
measure: Percent of plasma and sensor glucose values below 3.0 mmol/l
timeFrame: 24 hrs
measure: Standard deviation of plasma glucose
timeFrame: 24 hrs
measure: Frequency of hypoglycaemia
timeFrame: 24 hrs
measure: Frequency of hyperglycaemia
timeFrame: 24 hrs
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital
Study officials:
affiliation: University of Cambridge
name: Roman Hovorka, PhD
role: PRINCIPAL_INVESTIGATOR
References: