Imagine a wristwatch that pulses insulin through the skin without a needle pricking the skin.
“No pain. No site changes. Less consumables,” says engineer Nitin Saluja, PhD, co-inventor of this proposed insulin delivery system.
It would work like an electronic pancreas, communicating via Bluetooth to a continuous glucose monitor. A sensor, used separately, would track blood glucose in a closed-loop system.
This is not Sci-Fi, it’s SciDogma Research, a start-up from Bangalore partnered with Chitkara University in Chandigarh, India. The company’s concept recently won a People’s Choice Award at T1D Exchange’s 2018 Diabetes Innovation Challenge.
The SciDogma team, led by Satya Tapas, PhD, along with researchers from Chitkara University, came up with the idea of needle-less drug delivery through research on electroporation, or the use of an electrical pulse to open up pores.
In nature, there are moments when the skin temporarily stops acting as a protective barrier. For a few milliseconds, skin cell membranes actually open, allowing molecules to enter. Such a phenomenon can be recreated by applying to the skin a controlled, pulsed electric field. The skin then becomes a “bio-reservoir,” storing a pool of molecules below the surface for eventual uptake by the bloodstream.
The Chitkara University team exploited this phenomenon to attempt to create a kind of “e-pancreas,” artificially delivering insulin across the skin under the control of a closed-loop system. Because the insulin hormone is large and unwieldy, the researchers deployed molecular shuttles, called cell-penetrating peptides (CPPs), to ease insulin’s transit.
The investigators then filled a tiny cartridge on a wrist device with a combination of insulin and CPP and generated a 1-millisecond pulse every 100 milliseconds to deliver 0.1 unit of the hormone. The electrical pulses, timed in strict control with the system’s CGM and sensor, drive insulin through the skin for 12 hours. Because the skin itself becomes a bio-reservoir, a higher-than-needed dose is never administered, according to Saluja.
The team is now working through animal trials and clinical validation, consulting with endocrinologist Amit Lahoti, MD, at the University of Tennessee Le Bonheur Pediatric Specialists. Dr. Lahoti offers “the human perspective,” Saluja says. With his help, the E-Pancreas team will move into the next stage of development and focus on building a device with the end user’s needs in mind.
The goal is to make the device accessible to individuals with type 1 diabetes in India, where the majority of patients do not trust devices for diabetes management, says Tapas. Many of those using glucose meters cannot afford a traditional CGM device. In India, traditional pumps are currently sold for roughly $8,000. SciDogma’s wrist device is expected to cost only $73.
When asked why he participated in the 2018 Diabetes Innovation Challenge, Tapas noted that the event was “the strongest connector of patients, of the parents who are handling patients, [and] for feedback.”
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