Insulin Patch Pumps: Their Development and Future in Closed-Loop Systems

Abstract

Steady progress is being made toward the development of a so-called "artificial pancreas," which may ultimately be a fully automated, closed-loop, glucose control system comprising a continuous glucose monitor, an insulin pump, and a controller. The controller will use individualized algorithms to direct delivery of insulin without user input. A major factor propelling artificial pancreas development is the substantial incidence of-and attendant patient, parental, and physician concerns about-hypoglycemia and extreme hyperglycemia associated with current means of insulin delivery for type 1 diabetes mellitus (T1DM). A successful fully automated artificial pancreas would likely reduce the frequency of and anxiety about hypoglycemia and marked hyperglycemia. Patch-pump systems ("patch pumps") are likely to be used increasingly in the control of T1DM and may be incorporated into the artificial pancreas systems of tomorrow. Patch pumps are free of tubing, small, lightweight, and unobtrusive. This article describes features of patch pumps that have been approved for U.S. marketing or are under development. Included in the review is an introduction to control algorithms driving insulin delivery, particularly the two major types: proportional integrative derivative and model predictive control. The use of advanced algorithms in the clinical development of closed-loop systems is reviewed along with projected next steps in artificial pancreas development.

A Review of Safety and Design Requirements of the Artificial Pancreas

“…Two subtypes are available: the traditional insulin pump that uses an infusion set with relatively long tubing and the patch pump that is directly adhered to the skin and includes a very short (not visible) infusion set. The traditional pumps can suffer from tubing issues, whereas patch pumps can have problems with adherence and the separate controller 2. Compared to the previous described artificial pancreas components, little can be found about safety issues for infusion pumps in artificial pancreas systems.…”

Breaching the skin barrier through temperature modulations

“…The insulin PassPort™ patch is currently under development by Nitto Denko, after which it will be evaluated for possible approval by the FDA, before being released into the market [96]. Initial evaluation during Phase 1 clinical setup indicates that sustained insulin therapeutic levels were achieved for up to a 12 h application period, using the PassPort™ system [97,98]. Badkar et al assessed the feasibility of the PassPort™ system for the in vivo transdermal delivery of interferon alpha-2b (INFα2b) [99].…”

Closed-Loop System in the Management of Diabetes: Past, Present, and Future

“…Several patch pumps are currently available or are under development, including the OmniPod, the SoloÔ MicroPump (Medingo US, Inc., Tampa, FL), the FinesseÔ (Calibra Medical Inc., Redwood City, CA), the Cellnovo pump (Cellnovo Ltd., London, United Kingdom), the FreehandÔ system (MedSolve Technologies, Inc., Manhattan Beach, CA), the NanopumpÔ (Debiotech SA, Lausanne, Switzerland), the NiliPatch disposable insulin pump system (NiliMEDIX Ltd., Tirat-Carmel, Israel), the PassPort Ò system (Altea Therapeutics Corp., Atlanta, GA), the V-GoÔ (Valeritas, Inc., Bridgewater, NJ), and the CeQurÔ (Montreux, Switzerland) device. 91 Incorporating sensors with the infusion set is also under investigation, which may make CL more patient-friendly. 92 Many companies are investigating the incorporated sensor with infusion sets such as the Pod-Talk (Insulet Corp.) and the Medtronic integrated sensor and set.…”