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June 28, 2016 at 11:49 AM
(Bloomberg) — The discovery of insulin almost a century ago was one of the most remarkable achievements in medical history, transforming a deadly disease into a manageable one. Now diabetics are on the cusp of another breakthrough, one that could ease the endless task of manually testing and adjusting their blood sugar levels.
Medtronic Plc has filed for U.S. approval of the first artificial pancreas, a device the size of a smartphone that wirelessly connects an insulin pump and glucose monitor. The equipment, which remains outside the body, can take over for the malfunctioning organ that’s supposed to naturally produce insulin, the hormone that converts blood sugar to energy.
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While innovations in recent years made monitoring and injecting insulin easier, the potential approval of the MiniMed 670G would mark the first time that diabetics could turn over part of their daily routine to a machine. It measures blood sugar every five minutes and automatically administers or withholds micro-doses of insulin to keep patients in their target range.
“Patients are working 24 hours a day now,” said Richard Bergenstal, executive director of Park Nicollet’s International Diabetes Center in Minneapolis, who led the trial. “We want them to get control without spending every hour of the day worrying about their diabetes or preparing for the next event.”
Chasing His Goal
Les Hazelton welcomed the help. The 59-year-old marketing executive from Minnetonka, Minnesota, was one of the first patients enrolled in Medtronic’s trial for the technology. An avid bicyclist who finds it easy to avoid sweets, Hazelton nonetheless felt he was always “chasing” his blood sugar with insulin rather than getting ahead of it. Though he checked his levels seven times a day, he never in 17 years as a type 1 diabetic hit his blood sugar goals until he enrolled in the study.
“It was totally mind-blowing,” he said. “I like being in better control of my body and my disease. The more I know about what’s happening right now, the better I can manage it.”
Few patients maintain their blood sugar levels on their own. Less than 30 percent of adults with type 1 diabetes, the most severe form, meet the standards for blood sugar control, Bergenstal said. Younger patients do worse, with studies showing 75 percent of teenagers fail to meet the targets and reduce the risk of complications — from infections and organ damage to heart disease and coma.
Diabetics walk a fine line when it comes to their blood sugar. It can fall too low if treated too aggressively with insulin, causing symptoms including heart palpitations, fatigue, seizures, blurred vision or fainting.
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Cruise Control
Medtronic’s application to the U.S. Food and Drug Administration is based on the experience over six months of 124 patients who turned over most of their disease management to the artificial pancreas technology. The equipment, which continuously monitors blood sugar and administers insulin with a pump, is more like cruise control than a self-driving car. The patients actively used the technology, known as a hybrid closed-loop system, 84 percent of the time.
“This was them, in their homes, going about their lives,” said Francine Kaufman, chief medical officer and head of diabetes at Medtronic. “There was no remote monitoring. The closed loop is running the train now.”
