Closed-loop insulin delivery in the general ward (ANGIE02)
Research type
Research Study
Full title
An open-label, single-centre, randomised, parallel design study to assess the efficacy and safety of 72-hour automated closed-loop glucose control in comparison with conventional treatment in insulin-treated Type 2 diabetes
IRAS ID
111651
Contact name
Roman Hovorka
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Poor glycaemic control is a common and costly clinical problem affecting in-patients with diabetes and is associated with increased morbidity, mortality and length of stay. A third of patients experience medication errors while in hospital, with incorrect delivery of insulin figuring large within this. Current clinical practises of delivering insulin therapy as an intravenous insulin infusion or a combination of long-acting basal and rapid- acting mealtime insulin require significant input from staff. However, pressure of the time, , fear of hypoglycaemia and lack of specialist expertise in managing complex insulin protocols are significant barriers to optimal glucose control.
A proposed solution is an automated closed-loop system which enables subcutaneous delivery of insulin in response to real-time glucose sensor readings. The vital component of such a system is a computer-based control algorithm. Our unit has developed a Model Predictive Control (MPC) algorithm which translates, in real-time, information it receives from the real-time continuous glucose sensors. This computes the amount of insulin to be automatically delivered by the subcutaneous insulin pump using a model of glucose regulation. Utilisation of an automated glucose responsive system in the general wards would be beneficial as it could reduce the risk of hypoglycaemia while achieving targeted glucose levels. It could also reduce the work burden of healthcare providers managing inpatient blood glucose control . We hypothesise that closed-loop insulin delivery is likely to be an effective and safe method to manage hyperglycaemia in hospitalised non-critical care patients. The proposed study aims to assess the feasibility of closed-loop utilising the MPC algorithm in the general ward, as a stepping stone to justify future undertakings of larger clinical outcome studies.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
13/EE/0047
Date of REC Opinion
18 Mar 2013
REC opinion
Favourable Opinion