{"id":7701,"date":"2017-01-25T13:26:48","date_gmt":"2017-01-25T20:26:48","guid":{"rendered":"https:\/\/www.uchealth.org\/today\/?p=7701"},"modified":"2024-12-05T16:41:08","modified_gmt":"2024-12-05T23:41:08","slug":"cu-studies-paved-way-for-artificial-pancreas-approval","status":"publish","type":"post","link":"https:\/\/www.uchealth.org\/today\/cu-studies-paved-way-for-artificial-pancreas-approval\/","title":{"rendered":"CU studies paved way for artificial pancreas approval"},"content":{"rendered":"
<\/div>

The world\u2019s first artificial pancreas is coming to market much sooner than anyone expected \u2013 including the University of Colorado School of Medicine researchers whose work has been so central to the device\u2019s development and approval.<\/p>\n

The U.S. Food and Drug Administration on Sept. 28 approved the Medtronic MiniMed 670G system for patients with type 1 diabetes of ages 14 and older. The approval cites a clinical trial <\/a>for which CU\u2019s Barbara Davis Center for Childhood Diabetes was the largest proving ground.<\/p>\n

\u201cIt\u2019s a game-changer for people with diabetes,\u201d said Satish Garg, MD<\/a>, chief of the Barbara Davis Center\u2019s adult clinic, who led the local study cohort.<\/p>\n

Garg\u2019s colleague Robert Slover, MD<\/a>, who directs the Barbara Davis Center\u2019s pediatric clinic, led the study\u2019s largest pediatric site. He called the approval \u201chistoric.\u201d<\/p>\n

\u201cWe\u2019ve been working on this for the last 15 or 20 years one way or another \u2013 all the way from pump development and sensor development to algorithm development,\u201d Slover said. \u201cI think it will have enormous impact.\u201d<\/p>\n

Three in one<\/strong><\/p>\n

\"Diagram
Medtronic’\u0092s new system combines a glucose sensor, a transmitter, and an insulin pump to keep blood sugar levels more stable than existing systems typically can. (Courtesy Medtronic)<\/figcaption><\/figure>\n

The artificial pancreas is in fact a merging of three devices: a continuous glucose monitor (CGM) and an insulin pump, plus a glucose meter to calibrate the CGM. If blood glucose rises past a certain point, the CGM tells the pump to deliver more insulin to bring it back down; if blood sugar drops \u2013 or if algorithms in the CGM developed with the help of Barbara Davis Center researchers predict that it\u2019s about to drop \u2013 the CGM tells the pump to stop infusing insulin to give the patient\u2019s blood glucose a better chance to recover (technically, it\u2019s called \u201cpredicted low-glucose suspend\u201d). A smartphone-based app serves as a monitoring station for patients, parents or caregivers.<\/p>\n

The speed of approval \u2013 Garg said the FDA took just three months to make a decision that typically waits a year \u2013 took even Medtronic by surprise. As a result, the device is first expected to be available in spring 2017.<\/p>\n

The closed-loop pancreas has been a long time coming, with the Barbara Davis Center playing a big role throughout. The center\u2019s expertise in diabetes care, its large patient base and its skills and infrastructure in supporting clinical trials has made it a favored partner of technologists in academia and industry who are developing artificial pancreas hardware and software.<\/p>\n

Peter Chase, MD, emeritus executive director of the Barbara Davis Center\u2019s pediatric clinic and artificial pancreas pioneer, said the Medtronic device is a big step forward.<\/p>\n

\u201cThis is going to make diabetes care so much easier,\u201d Chase said. \u201cIt\u2019s exciting for our kids. It\u2019s exciting for our families.\u201d<\/p>\n

Self-driving pumps<\/strong><\/p>\n

\"Headshot
Peter Chase, MD, an early proponent of the artificial pancreas concept.<\/figcaption><\/figure>\n

The artificial pancreas does not cure type 1 diabetes, an autoimmune disease that about a million U.S. adults and 200,000 kids have. With type 1 diabetes, one\u2019s own immune system kills the pancreatic islet cells that produce insulin, a protein that helps move glucose \u2013 a key metabolic fuel \u2013 from the bloodstream to the cells. The Medtronic device and others expected to follow in the coming years take a big step toward automating the difficult and error-prone process of controlling blood sugar levels, thereby minimizing the long-term eye, kidney, nerve and cardiovascular damage diabetes can cause.<\/p>\n

The data show Medtronic\u2019s artificial pancreas to work better than insulin pumps whose delivery depends solely on human intervention. The key statistic, Chase says, is that the Medtronic device kept the trial\u2019s participants within the desired blood glucose range about 75 percent of the time.<\/p>\n

\u201cWith current methods, we aim for 50 percent, and it\u2019s rare that we get that,\u201d Chase said. \u201cIt\u2019s going to bring [blood glucose levels] into almost the normal range, and it\u2019s going to greatly reduce the likelihood of microvascular complications. In five years, I would predict that eye, kidney, and nerve damage will be reduced by at least half.\u201d<\/p>\n

Slover added that the device\u2019s guardrail against hypoglycemia \u2013 crashing blood sugar \u2013 will let providers be more aggressive with insulin dosing and improve average blood glucose levels, something doctors have \u201cwanted to do for years.\u201d<\/p>\n

The device\u2019s greatest strength is ability to control glucose levels when patients can\u2019t. Nighttime control has been a huge problem: among adults, more than half of diabetic seizures from plunging blood sugar levels happen during sleep. Among children, it\u2019s higher yet \u2013 75 percent. Maintaining nighttime control was a major artificial pancreas goal from the beginning, Chase said. CGMs fitted with low-glucose alarms can help, but his group, with an assist from a military night-vision camera, found that 71 percent of teenagers sleep right through them.<\/p>\n

Big interest<\/strong><\/p>\n

\"Headshot
Robert Slover, MD, director of the Barbara Davis Center’s pediatric clinic, called the approval of the artificial pancreas “historic.”<\/figcaption><\/figure>\n

Slover\u2019s pediatric trial showed the Medtronic device to be safe and effective for kids as young as eight years old, and larger trials with this age group should soon lead to FDA approval. The system has yet to be tested in children under the age of eight, but those studies are also planned. Meanwhile, use in children under the age of 14 constitutes \u201coff-label\u201d use, and use by children under the age of eight is untested.<\/p>\n

\u201cBut that research will get done and then the age range will get extended,\u201d Slover said.<\/p>\n

If Garg\u2019s study participants were any measure, the artificial pancreas should fly off the shelves \u2013 assuming insurance coverage for a device estimated to cost several thousand dollars. Eighty-five percent of the Garg\u2019s adult-study participants asked if they could keep the device after the three-month study ended, which Medtronic and the FDA let them do. Slover said the Barbara Davis Center expects to run 25 education and training sessions a week once the device is on the market. He says he and colleagues are getting emails from patients all over the world.<\/p>\n

\u201cA family in Saudi Arabia wanted to know when they could come and get their pump,\u201d Slover said.<\/p>\n

Michael McDermott, MD<\/a>, medical director of University of Colorado Hospital\u2019s endocrinology, metabolism and diabetes practice, said he would strongly recommend the device.<\/p>\n

\u201cI think this is the direction that type 1 diabetes management needs to go, and I hope someday that people with type 2 diabetes will have the same coverage,\u201d McDermott said.<\/p>\n

McDermott said about half of UCH\u2019s roughly 1,500 type 1 diabetes patients are already using an insulin pump and\/or CGM, which would make for a straightforward transition. But he added that some patients who still prefer to do manual finger-pricks and injections may also make the switch.<\/p>\n

\u201cThey\u2019ve been waiting for a big quantum leap as opposed to the incremental advances,\u201d McDermott said.<\/p>\n

But he cautioned that the Medtronic artificial pancreas is still a long way from being as sophisticated as the actual bodily organ. The data show the device to work well between meals, but the wearer still must estimate carbohydrates and enter them into the pump before meals so the device can deliver a pre-meal insulin booster, which takes about 20 minutes to take effect (the pancreas does the same thing with no delay because it delivers insulin directly into the digestive tract). Patients must also calibrate the CGM a couple of times a day with a drop of finger-prick blood.<\/p>\n

Looking ahead<\/strong><\/p>\n

Future devices will probably enter meals into the equation, McDermott said. Chase said he also anticipates later versions to be attuned to individual traits and behaviors, so as to adapt quickly to a young child who\u2019s insulin-sensitive or a senior who\u2019s insulin-resistant. Other improvements might include recognizing regular exercise patterns, say for a football player who practices a certain time every day \u2013 or even illness, which also affects metabolism. Also, future devices might deliver not only insulin, but also glucagon, which the pancreas secretes to counteract low blood sugar, and perhaps also incretins that help regulate the gut\u2019s sugar absorption.<\/p>\n

\u201cLater generations will have a much finer ability to make adjustments for individual sensibilities,\u201d Chase said.<\/p>\n

Garg\u2019s team is already testing Medtronic\u2019s next-generation device, he says. Other device makers are at least a year behind, Chase estimates, but he expects the first competitors\u2019 offerings to hit the market in late 2017 or 2018.<\/p>\n

Chase wonders if the surprisingly rapid success of the artificial pancreas will refocus the attention of major funders such as the National Institutes of Health and JDRF<\/a> \u2013 the latter which has spent $116 million on artificial pancreas projects over the past decade \u2013 on curing type 1 diabetes.<\/p>\n

\u201cWe\u2019re making inroads with immunosuppression and islet transplantation,\u201d Chase said. \u201cWe\u2019ve got a long ways to go yet, but there\u2019s the possibility for a cure in the future.\u201d<\/p>\n

For now, Slover is enjoying the moment. He, Garg and Chase have been around long enough to remember the days before reliable blood glucose testing or fast-acting insulin, he said. Then came the first insulin pumps, which were \u201cbig like bricks.\u201d<\/p>\n

\u201cAnd to think that we\u2019ve moved from there to a technology that really will protect kids from hypo- and hyperglycemia most of the time,\u201d Slover said. \u201cIt\u2019s just amazing and wonderful.\u2019\u2019<\/p>\n","protected":false},"excerpt":{"rendered":"

The world\u2019s first artificial pancreas is coming to market much sooner than anyone expected \u2013 including the University of Colorado School of Medicine researchers whose work has been so central to the device\u2019s development and approval. 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