e-Health

ClosedLoop4Meal: New strategies for postprandial glycaemic control using insulin pump therapy in type 1 Diabetes

ClosedLoop4Meal aims at developing efficient and safe strategies for postprandial glucose control in type 1 diabetic patients, to relieve the burden of hypoglycaemia. It will focus on insulin-pump-based therapies, both in open loop and closed loop in combination with a subcutaneous continuous glucose monitor (Artificial Pancreas – AP).

Diabetes is a chronic disease characterised by absolute or relative insulin deficiency (type 1 diabetes mellitus – T1DM and type 2 diabetes mellitus – T2DM, respectively). Continuous subcutaneous insulin infusion (CSII) through an insulin pump has shown to be effective in the reduction of HbA1c (an index of mean glycaemic control) in adults with type 1 diabetes, however, hypoglycaemia episodes are not reduced. In the last two decades, technological progresses have fuelled research on closed-loop glucose control systems (the so-called artificial pancreas) combining an insulin pump and a subcutaneous continuous glucose monitor (CGM), for a more effective treatment of type 1 diabetic subjects. Although satisfactory enough clinical results have been reported on overnight glucose control, postprandial (post-meal) glucose control is still an open issue due to controller overcorrection leading to hypoglycaemia. The lack of accuracy of current continuous glucose monitors, especially in the hypoglycaemic range, has also been identified as a limiting factor in the development of an artificial pancreas.

The general objective of this project is thus the development of new efficient and safe strategies for postprandial glucose control in type 1 diabetic patients, aiming at the relieve of the burden of hypoglycaemia. This project will focus on insulin-pump-based therapies, both in open loop (CSII), and closed loop in combination with a subcutaneous continuous glucose monitor (artificial pancreas). This will be achieved through: (1) gaining a better understanding of the glycaemic effect of a mixed meal perturbation; (2) the development of new robust control strategies to counteract efficiently meal perturbations without hypoglycaemia risk, (3) the understanding of the dynamic relationship between plasma and interstitial glucose to develop new calibration algorithms for CGM with improved accuracy and hypoglycaemia detection; and (4) with the development of fault-detection algorithms for the supervision of insulin infusion. It is expected that the improvement in control algorithms, measurement accuracy and fault-detection systems will allow getting the performance and safety required for automated post-meal control in type 1 diabetes.

The project will produce highly innovative exploitable results. In the short-term: (1) new clinically validated method for insulin delivery at mealtime able to deal efficiently with high-content CHO meals. This method would thus incorporate unique features to insulin pumps, making the selection of a bolus easier for the patient and increasing its efficiency in current pump therapy. The potential is thus enormous with a short-term impact on patient’s well-being; and (2) New calibration algorithm with improved accuracy in hypoglycaemia. This would make continuous glucose monitoring more reliable and suitable for the detection of hypoglycaemias, increasing patients and physicians’ confidence in this technology. In a more long-term, after the suitable clinical trials, an efficient and safe artificial pancreas incorporating the control algorithms and new CGM technology developed in this project.