Devices close in on full management of diabetes

Medical technology is entering a new era in Type 1 diabetes management with Novo Nordisk’s superfast-acting insulin that begins reducing blood sugar levels in just 2½ minutes.

But even that insulin isn’t fast enough to allow for a fully automated artificial pancreas.

“Insulins have come a long way and faster-acting versions such as Novo Nordisk’s insulin, Fiasp, are helping people better manage their diabetes. That said, we are still challenged by delivery through the skin and will require further advances that help to make these systems more automatic,” said Aaron Kowalski, chief mission officer for JDRF International, formerly the

Juvenile Diabetes Research Foundation. He recently visited Pittsburgh.

The foundation continues working with companies on various fronts, including incorporating important hormones such as amylin and glucagon into artificial pancreas devices for more natural prevention of high and low swings in blood-glucose levels.

“It’s not yet snap your fingers and you have a fully mechanical artificial pancreas,” he said. “More innovation will be beneficial.”

Fiasp received U.S. Food and Drug Administration approval in September and became available to patients in early February.

Ken Inchausti, director of reputation & media relations for Novo Nordisk, said his company is working with medical device makers, which he declined to identify, to use Fiasp in their systems. The insulin can be administered at the beginning of a meal or within 20 minutes after starting a meal “due to its appearance in the blood in approximately 2½ minutes,” according to a Novo Nordisk press release.

“We are aware of that need for quicker-acting insulin,” Mr. Inchausti said, noting that the company continues working on types of insulin that will work best in such devices.

Meanwhile, Deidre Ibsen, the global brand delivery leader for Eli Lilly and Co., said the company has altered its fast-acting Humalog insulin to work even faster. The resulting ultra-rapid insulin, Lispro, is undergoing Phase III clinical trials with anticipation that it could reach the market in 2019.

“As far as artificial pancreas technology goes, a lot of companies are working in this space and working with available insulins, and they can advance these systems with [Lispro],” she said.

Trials already show that Lispro lowers postprandial glucose levels by 44 percent for those with Type 1 diabetes and 105 percent for people with insulin-dependent Type 2 diabetes, Eli Lilly announced Saturday during the American Diabetes Association’s 78th Scientific Sessions that run through Tuesday in Orlando, Fla.

For now, Ms. Ibsen said, artificial pancreas devices — more technically described as “automated insulin delivery systems” — are designed to work with longexisting faster-acting insulins. Device companies might need to rewrite algorithms before the devices can use ultra-fast insulins.

And don’t get the wrong message. Mr. Kowalski, who holds a doctorate in molecular genetics, said Medtronic’s MiniMed 670G hybrid closed-loop artificial pancreas is important technology with measurable improvements in blood sugar control. It represented a breakthrough advance in diabetes management when it was approved in September 2016 and reached the market about this time last year.

In the meantime, Fiasp represents another important addition to the arsenal for faster normalization of blood sugar levels, whether it, in time, will be used in artificial pancreas technologies or administered more traditionally with insulin pumps or injections.

Ever more medical device companies are working on closed-loop artificial-pancreas devices that generally use continuous glucose monitors that communicate with insulin pumps, all based on software algorithms, to keep blood sugar levels close to or within the normal range without dramatic and often dangerous swings. The devices are particularly helpful in preventing low blood sugar levels overnight.

Mr. Kowalski said Bigfoot Biomedical, Roche in partnership with Senseonics and TypeZero, and Tandem Diabetes Care are closing in on getting artificial pancreas devices to the market, with Tandem saying its device could be available as early as this summer. Eli Lilly also has its own automated insulin delivery system that is expected to be on the market within the next two years, with other methods in the works.

These companies use different methods than does Medtronics, in some cases using glucagon to prevent low blood sugar known as hypoglycemia. Reducing the risk of dangerous low blood sugar levels, the use of glucagon allows for more aggressive insulin therapy to keep glucose levels normal or close to normal.

Mr. Kowalski said JDRFfunded research is underway to use amylin, another hormone produced in the pancreas, to reduce high glucose levels more quickly.

For now, the Medtronic Minimed device requires a patient to add boluses of insulin prior to meals to offset spikes in blood sugar. Studies show that does a good job in maintaining normal or near-normal glucose levels between meals with the key advantage of preventing low blood sugar levels overnight.

Humalog produced by Eli Lilly, Novolog by Novo Nordisk and Apidra by Sanofi-Adventis are fastacting insulin types that start to activate in 10 to 15 minutes and peak in 1½ to 2½ hours, diabetes.com states. Those insulins were breakthrough treatments decades ago, but their activation rates are too slow to replicate how the beta cells in the pancreas release insulin, then in complex but quick biochemistry, enter the bloodstream to unlock and allow blood glucose into cells for use as energy.

At its website, the FDA said it has been “working with diabetes patient groups, diabetes care providers, medical device manufactures and researchers to advance the development of an artificial pancreas.”

“FDA’s efforts include prioritizing the review of research protocol studies, providing clear guidelines to industry, setting performance and safety standards, fostering discussions between government and private researchers, sponsoring public forums, and finding ways to shorten study and review time,” it says.

“There are also many research projects underway looking at the feasibility of these device systems in hospital settings. For more information on these and other clinical trials, visit www.clinicaltrials.gov.