The forecast for diabetes management technologies is variable: While competition remains healthy and proactive, with some manufacturers making progress on automated systems for continuous glucose monitoring (CGM) and insulin pumps, launch dates for newer diagnostics remain on the far horizon. James Hayward, principal analyst at IDTechEx, a global research and consulting firm, summarized the landscape of diabetes technology in a new market report that represents insights from 75 companies.
“There are drivers to minimize the discomfort and inconvenience of a finger prick test. Today this is manifesting as the growth in CGM, taking finger pricking down to roles such as double-checking, calibration, or other supporting roles only,” Hayward told CLN Stat. There’s also a strong movement toward more integrated diabetes management software tools and apps to help patients better manage their disease. But as Hayward pointed out in his report, challenges remain for diagnostic innovation.
Two areas that have faltered include noninvasive CGM, which has produced a flurry of very short-lived companies, and oral insulin delivery, which has never taken off despite much discussion over this approach. Other emerging diagnostic technologies, such as remote glucose tolerance testing, using Escherichia coli bacteria to change color in the presence of sugar, and optical sensors to diagnose infants, have been slow to launch.
“The challenge with each of these technologies is that many of them have been discussed, researched, or in some way in the pipeline for many years and in most cases decades,” Hayward said. The report includes examples of work in transition between academic labs and commercial use, citing timelines of 2 to 5 years for commercialization. However, “with huge steps (e.g. regulatory approval, commercial validation, etc.) to come, it is difficult to be too confident on these timelines,” he observed.
CGM is an area that’s growing rapidly, driven in part by automatic, user-friendly CGM devices that offer a convenient alternative to standard glucose test strips. “We found that the recent significant investments in CGM from the last decade are resulting in significant growth throughout this sector. Now that the main technology barriers are being overcome and CGM options are viable products, the growth in this sector has and will continue to be significant,” Hayward said. While this doesn’t mean the end of test strips, it does signify that they’ll have a role that supports CGM over the long term, rather than serve as a primary method, he emphasized.
Revenue data for these two sectors over the last 10 years show strong growth for CGM’s small pool of manufacturers with approved devices. Patients using the technology have been able to improve HbA1C by 0.4% to 1%, demonstrating superior glucose control in comparison to test strips. “We expect this shift towards CGM to continue to gain momentum,” Hayward said.
Wearable CGM options such as sensors and subcutaneous implants are on the rise and have shown steady improvements in technology. Senseonics, for example, has developed an implant of this type that communicates with a wearable transmitter. Hayward anticipates that as the industry matures, calibration will be minimized, as prices go down and lifetime use goes up.
“Beyond these mainstream options, there are still large numbers of groups discussing other techniques and the potential of non-invasive glucose monitoring,” Hayward wrote. Given the lack of commercial success in this area, however, it’s unlikely that this market sector will take off in the near future.
Many insulin pump and CGM manufacturers have been eyeing the possibility of merging CGM devices and insulin pump technology to create an automatic feedback loop or “closed-loop” system. “The idea is to create an ‘artificial pancreas’ by using glucose sensing and insulin/glucagon delivery for automatic diabetes management,” Hayward explained. Developers are closing in on this goal, receiving approvals from the Food and Drug Administration (FDA) to advance this type of system, Hayward said. Medtronic, for example, received approval from FDA for its “hybrid closed-loop” MiniMed 670G system.
While the technology has fairly reliable sensing and delivery, companies still include a step that asks patients “are you sure?” when suggesting insulin dosing. Passing this responsibility from the patient to the manufacturer has huge legal implications, Hayward said. “This is why we think it will be a long time before this step can realistically think about being removed,” he said.
Manufacturers have also taken steps to bulk up insulin pump data, intelligence, and software, although these are few and far between. While Roche has made headway in its digital health technology to improve insulin pumps, “these advances represent the leading edge of the industry, with the majority of diabetics in the world still using manual application of insulin via pens, let alone insulin pumps or closed-loop systems,” Hayward noted.
Hayward also expounded on tests used in the management of diabetes side effects. The β-ketone test strip, for example, measures concentration of β-hydroxybutyrate in the blood to help identify diabetic ketoacidosis. In the meantime, companies have been looking at developing special footwear to identify or predict diabetic foot ulcers. “Future targets around management of side effects could include things like smart bandages for following the progress of recovery from ulceration or other complications from peripheral neuropathy,” he wrote.