Seraccess® ONE - Breakthrough wearable Artificial Pancreas Device System for patients suffering from severe glycemic dysregulation

Fully automated, wearable closed-loop APDS for highly accurate and precise blood-glucose monitoring and control for the diabetes patients who need it most. Seraccess® ONE is semi-miniaturized wearable which 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

Why Seraccess® ONE?

 

Seraccess® ONE is a wearable device which operates nearly in real time and in direct communication with the patient's bloodstream. The nearly delay-free, highly accurate and precise blood-glucose measurement allows to administer the exact amount of insulin needed - via a commercially available standard catheter - directly into the bloodstream to manage blood glucose within the target range. An increase in time in range translates directly into a reduction of short- as well as long-term complications. Seraccess® ONE is a fast acting closed-loop control system which can revolutionize therapy in this patient group.