A Review of Safety and Design Requirements of the Artificial Pancreas.

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Annotation Summary

Term Occurence Count Dictionary
Insulin 1 endocrinologydiseasesdrugs
diabetes mellitus 1 endocrinologydiseases
diabetic ketoacidosis 1 endocrinologydiseases
hyperglycemia 6 endocrinologydiseases
hypoglycemia 19 endocrinologydiseases

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Review

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Select Drug Character Offset Drug Term Instance
Insulin 27774 Pharmacodynamic action of rapid-acting insulin peaks roughly around 90 min and action may persist up to 8 h. Insulin pharmacokinetics was found to have substantial variability between patients.[7] Furthermore, the insulin
Select Disease Character Offset Disease Term Instance
diabetes mellitus 4974 search components: type 1 diabetes, artificial pancreas, safety or design. The search query was: (“ diabetes mellitus , type 1”[MeSH Terms] OR “type 1 diabetes”[tiab]) AND (“pancreas, artificial”[MeSH Terms] OR
diabetic ketoacidosis 14141 case of a bi-hormonal system. These hazards may cause severe hypoglycemia, severe hyperglycemia or diabetic ketoacidosis . The clinical requirements for safety are that the incidence of these events should not be increased
hyperglycemia 6767 and stabilize blood glucose by limiting excursions, while limiting the occurrence of hypoglycemia and hyperglycemia . The adequacy of a patient’s mean blood glucose levels is assessed with the glycated hemoglobin (HbA1c)
hyperglycemia 14124 other hormones in case of a bi-hormonal system. These hazards may cause severe hypoglycemia, severe hyperglycemia or diabetic ketoacidosis. The clinical requirements for safety are that the incidence of these events
hyperglycemia 16319 glucose value increase the risk of hypoglycemia, whereas sensor under readings increase the risk of hyperglycemia , because of inappropriate insulin delivery.[8],[70] In addition, glucagon was less effective in the
hyperglycemia 17698 Furthermore, the accuracy of enzyme glucose sensors is less during hypoglycemia compared to eu- and hyperglycemia .[43],[46]Several factors contribute to sensor inaccuracy, of which the most known factors are discussed
hyperglycemia 32027 control algorithms, because this enables the delivery of an insulin bolus to minimize postprandial hyperglycemia . Although on average such systems resulted in higher amount of time in range compared to systems without
hyperglycemia 50530 patients, which increases safety as interruption of the glucose control increases the chance of hypo- and hyperglycemia . For all aspects that require interaction with the user, the patient should be involved in the design
hypoglycemia 6750 glucose levels and stabilize blood glucose by limiting excursions, while limiting the occurrence of hypoglycemia and hyperglycemia. The adequacy of a patient’s mean blood glucose levels is assessed with the glycated
hypoglycemia 7489 practical for patients to constantly monitor their glucose level and react on it. Furthermore, to avoid hypoglycemia , patients typically prefer slightly hyperglycemic glucose levels over low-normal values,[27] especially
hypoglycemia 8492 glucose estimate reaches or approaches a low glucose value in order to prevent or reduce the severity of hypoglycemia .[9],[48] The next step is a Control-to-Range (CTR) system. This system not only reduces the rate of
hypoglycemia 14103 also of glucagon or other hormones in case of a bi-hormonal system. These hazards may cause severe hypoglycemia , severe hyperglycemia or diabetic ketoacidosis. The clinical requirements for safety are that the incidence
hypoglycemia 16254 improve.[58],[69] Large positive sensor deviations from the true glucose value increase the risk of hypoglycemia , whereas sensor under readings increase the risk of hyperglycemia, because of inappropriate insulin
hypoglycemia 16447 inappropriate insulin delivery.[8],[70] In addition, glucagon was less effective in the prevention of hypoglycemia when delivery was delayed because of positive sensor deviations in a bi-hormonal artificial pancreas
hypoglycemia 17665 safe glucose control.[46],[76],[77] Furthermore, the accuracy of enzyme glucose sensors is less during hypoglycemia compared to eu- and hyperglycemia.[43],[46]Several factors contribute to sensor inaccuracy, of which
hypoglycemia 21913 SMBGs may only be performed every 12 h (or even up to 48 h); this particularly affects the risk of hypoglycemia .[34],[46],[65] Averaging multiple sensors can improve accuracy and especially reduce large sensor errors,
hypoglycemia 25237 therefore difficult to include in closed-loop glucose control.[19],[45] Unannounced exercise was related to hypoglycemia in a clinical trial in twelve adolescents using closed-loop basal insulin delivery [24] and an in silico
hypoglycemia 25594 well before exercise will be needed to reduce the insulin delivery in time to prevent exercise-related hypoglycemia , because of the delayed action of subcutaneously infused insulin. Safety concerns of manual announcements
hypoglycemia 26216 Especially for exercise performed before the evening this may be an additional measure to reduce the risk of hypoglycemia .[51] Sensors that are being investigated to measure exercise for closed-loop glucose control include
hypoglycemia 26501 sensor to measure exercise should only be included into an artificial pancreas if it reduces the risk of hypoglycemia .[19]Glucose Control AlgorithmsThe brain of the artificial pancreas consists of the algorithms that control
hypoglycemia 30077 glucose control algorithms should contain multiple specific measures to further mitigate the risk of hypoglycemia .[11],[23] Options are to calculate the insulin-on-board to explicitly take the delayed action of insulin
hypoglycemia 30240 insulin-on-board to explicitly take the delayed action of insulin into account, to use algorithms that predict hypoglycemia and consequently reduce or stop insulin infusion, or to use pre-programmed basal insulin rates as the
hypoglycemia 30537 values increase.[23],[56],[62],[77] These measures are, however, not expected to be able to prevent hypoglycemia in all daily life situations, because of the prolonged action of insulin and only one-way control is
hypoglycemia 30758 possible with insulin.[34],[63],[76] To further mimic physiologic glucose control and mitigate the risk of hypoglycemia , the use of glucagon may become an important safety measure,[4],[63],[76] especially for fully automated
hypoglycemia 31760 administration.[12] At last, alarms should be given to recommend the patient to take carbohydrates in case hypoglycemia does occur.[23]Furthermore, glucose control algorithms can depend on manual announcements to indicate
hypoglycemia 38906 components.ComponentSafety aspectsMitigation measuresContinuous glucose monitorInaccuracies, especially during hypoglycemia MARD <15%Moderate (ARD ≥20%) and large (ARD ≥40%) measurement errorsIdentify situations with reduced
hypoglycemia 40112 target;Responsive to changes in glucose trendsDelayed action of s.c. infused insulinSpecific measures aimed at hypoglycemia risk, e.g. insulin-on-board calculation, use of glucagonVariability PK/insulin sensitivity between/within

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