Clinical Results of an Automated Artificial Pancreas Using Technosphere Inhaled Insulin to Mimic First-Phase Insulin Secretion

Abstract

Intensive glycemic control in type 1 diabetes has been shown to reduce the incidence and progression of microvascular and macrovascular complications. 1,2 One validated way to improve glycemic control is the use of insulin pumps and/or continuous glucose monitors (CGMs). 3-5 However, many patients do not wear or manage the devices optimally 6-9 and clinical penetration is far from complete, even in the top clinical centers. 10 The limited and/or suboptimal use of diabetes technology can be traced, in part, to the "hassle factor," the substantial degree of time, effort, patience, and appropriate decision-making that are required to monitor, operate, and maintain the devices. Thus, systems that automatically modify insulin delivery based on glucose data could facilitate more effective glycemic management, better quality of life, and wider use of diabetes technologies. Such a partially or fully closed-loop system, often referred to as an artificial pancreas (AP), could also lower the risk of acute hypoglycemia by reducing insulin delivery based on the prediction of the control algorithm. Developing an AP has been identified as a priority by both patient advocacy organizations 11 and federal health agencies. 12 However, for an automated system to improve on the safety and efficacy of current diabetes management, several difficulties must be overcome. One of the biggest challenges for AP systems is meal time (prandial) glucose control. If the AP system delivers insulin 582061D STXXX10.

ISPAD Clinical Practice Consensus Guidelines 2018: Diabetes technologies

“…Early studies focused on demonstrating feasibility of automated insulin delivery in carefully controlled in‐clinic studies, and were conducted in a range of patients including children, adolescents, adults, and in pregnant women . These included single hormone, dual hormone systems, and the incorporation of insulin absorption adjuncts . In‐clinic studies that simulated hypothetical real world challenges including exercise, alcohol, high fat meals, and inaccurate continuous glucose sensors followed, and demonstrated that the automated insulin delivery systems remained safe and effective.…”

Progress in Diabetes Technology: Developments in Insulin Pumps, Continuous Glucose Monitors, and Progress towards the Artificial Pancreas

“…Studies combining these agents with diabetes technology show early promise to help mitigate postprandial hyperglycemia. 86–90 …”

Place of technosphere inhaled insulin in treatment of diabetes

“…First, patients with type 1 diabetes who are taking basal insulin once daily, but prefers to take their prandial insulin in the inhaled formulation; second, patients with type 2 diabetes uncontrolled on oral agents, and are reluctant to start subcutaneous insulin due to needle phobia or other reasons; third, patients already on subcutaneous prandial insulin who develop frequent late post-prandial hypoglycemia (4-5 h after meals); fourth, patients who develop skin reactions to insulin subcutaneous injections such as lipoatrophy or lipohypertrophy. Another potential place of TI that is under investigations includes its use in combination of automated artificial pancreas to provide rapid insulin delivery right after meals[20]. …”