Diabetes Mellitus, Type 1 Clinical Trial
Official title:
SAFE-AP: Automatic Control of Blood Glucose Under Announced and Unannounced Exercise
Achieving near-normoglycemia has been established as the main objective for most patients
with diabetes. Despite growing evidence about the health benefits of regular exercise in
diabetes, exercise-associated glycemic imbalance remains a challenge in subjects with type 1
diabetes (T1D) due to a higher risk of hypoglycemia.
Automatic glucose control, the so-called artificial pancreas (AP) or closed-loop system, may
represent the ideal solution for reaching the therapeutic goals in diabetic patients.
Intuitively, closed-loop insulin delivery may be superior to open-loop insulin delivery due
to a better compensation of the variability of subcutaneous insulin absorption and the
intra-subject insulin sensitivity. However, several challenges exist to effectively realize
an optimal closed-loop control of blood glucose during exercise. Indeed, the physical
exercise induces one of the major glucose perturbations that need to be controlled by an
artificial pancreas and is currently one of the main challenges found in clinical validations
of the few existing prototypes of an artificial pancreas. In particular, experiments carried
out with the currently used algorithms for glucose control (the so called PID
(proportional-integrative-derivative) and MPC) showed that closed-loop insulin delivery is
deteriorated by exercise, increasing the risk of hypoglycemia even with pre-exercise
carbohydrate ingestion when non-announcement strategies are used.
In this project, a rigorous clinical testing of a novel closed-loop controller ('artificial
pancreas') will be carried out in T1D patients treated with continuous subcutaneous insulin
infusion (CSII). The innovative element of the controller is a safety auxiliary feedback
based on sliding mode reference conditioning (SMRC), which has been demonstrated to limit
over-insulinization and the resulting hypoglycemia, reducing glycaemic variability.
Announced and unannounced exercise will be performed in T1D subjects treated with CSII,
comparing the number of hypoglycemic episodes with a controller-driven insulin delivery
(closed-loop study) based on continuous subcutaneous glucose monitoring (CGM).
If any glucose value <70 mg/dL 15 gr of glucose will be provided. Moreover 15gr of glucose
will be provided in AP studies when AP system recommends it.
The hypothesis is that closed loop control will provide better glycemic control, with less
hypoglycemia episodes.
n/a
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