Seraccess® ONE / NEXTRA APDS (Artificial Pancreas Device Systems)

Seraccess® ONE is a fully automated, semi-miniature wearable closed-loop APDS for highly accurate and precise blood-glucose monitoring and control for the diabetes patients who need it most. Seraccess® ONE operates with a commercially available standard catheter.

Brittle diabetes describes a group of diabetes patients suffering from life-changing disruptions due to severe glycemic dysregulation, indicating a condition of instability of glycemic control requiring frequent hospitalizations and causing impaired quality of life and enormous economic cost. These patients are at risk for many unfortunate consequences: poor glycemic control with its complications, more emergency room and hospital admissions, strains on relationships, and greater healthcare utilization and diabetes distress. Current standard of care cannot significantly help these patients, they spend very little time within the target blood glucose range.¹ Brittle diabetes is characterized by severe instability of blood glucose levels with frequent and unpredictable episodes of hypoglycemia often requiring hospitalization. Hypoglycemia unawareness is one of the hallmarks of brittle T1D. Hypoglycemia unawareness is especially dangerous because the hypoglycemic individual will not know to take corrective action to prevent further deterioration. If left untreated, hypoglycemia may become severe, resulting in confusion, disorientation, loss of consciousness, or, in extreme cases of prolonged hypoglycemia, permanent brain damage or death.² Equally dangerous are pronounced and prolonged hyperglycemias, which can lead to diabetic ketoacidosis (DKA) and associated frequent hospitalizations.

Secondary complications, including neuropathy, cardiovascular disease, and retinopathy can be especially common in brittle T1D and there is a significant excess mortality in these patients despite intensive insulin therapy.³ A twenty-year outcome study showed a shockingly 50% mortality rate in a group of women with a mean age of 42 years. In a normal non-brittle type 1 diabetes population, the expected death rate over such a period would be about 5%.^4,5

Fully miniaturized and automated, wearable closed-loop APDS for highly accurate and precise blood-glucose monitoring and control for the diabetes patients who need it most and beyond. Seraccess® NEXTRA operates with a proprietary transdermal port (SeraPort), the sophisticated architecture of which makes the sampling of minuscule amounts of blood possible in the first place. Only 20µl to 30µl of blood are needed to perform a highly accurate and precise blood glucose measurement. Seraccess® NEXTRA will be the first and only fully miniaturized and automated, wearable technology for the treatment of diabetes which communicates and interacts directly with the blood – and therefore the only solution which can meet the requirements for a true artificial pancreas. Not only for patients suffering from severe glycemic dysregulation, but also beyond into the broader indication of moderate glycemic dysregulation.

Brittle diabetes describes a group of diabetes patients suffering from life-changing disruptions due to severe glycemic dysregulation, indicating a condition of instability of glycemic control requiring frequent hospitalizations and causing impaired quality of life and enormous economic cost. These patients are at risk for many unfortunate consequences: poor glycemic control with its complications, more emergency room and hospital admissions, strains on relationships, and greater healthcare utilization and diabetes distress. Current standard of care cannot significantly help these patients, they spend very little time within the target blood glucose range.1 Brittle diabetes is characterized by severe instability of blood glucose levels with frequent and unpredictable episodes of hypoglycemia often requiring hospitalization. Hypoglycemia unawareness is one of the hallmarks of brittle T1D. Hypoglycemia unawareness is especially dangerous because the hypoglycemic individual will not know to take corrective action to prevent further deterioration. If left untreated, hypoglycemia may become severe, resulting in confusion, disorientation, loss of consciousness, or, in extreme cases of prolonged hypoglycemia, permanent brain damage or death.2 Equally dangerous are pronounced and prolonged hyperglycemias, which can lead to diabetic ketoacidosis (DKA) and associated frequent hospitalizations. Secondary complications, including neuropathy, cardiovascular disease, and retinopathy can be especially common in brittle T1D and there is a significant excess mortality in these patients despite intensive insulin therapy.3 A twenty-year outcome study showed a shockingly 50% mortality rate in a group of women with a mean age of 42 years. In a normal non-brittle type 1 diabetes population, the expected death rate over such a period would be about 5%.4,5