This was posted by MedPage and AACE last week … some exciting news from Dr. Ed Damiano. He’s working on a proposal for a year-long study (with 480 participants, 160 of whom will be belong to a control of usual care) to compare outcomes of HbA1c and mean CGM levels. He even commented on the cooperative approach by the FDA on designing the device. Perhaps we could offer up our support group for this study? Would you try it? I KNOW I would, in a flash!
A year-long trial is the next test for the device, developer says.
by Parker Brown
Staff Writer, MedPage Today
NASHVILLE — The developer of a bionic pancreas came here to deliver good — if early — news, and he did just that before a rapt audience.
Edward Damiano, PhD, of Boston University, revealed the partial results at the annual meeting of the the American Academy of Clinical Endocrinologists and said that his team is planning a large, year-long, randomized trial of the device.
The artificial pancreas — which automatically regulates insulin levels and dispenses glucagon and insulin according to an algorithm — improved glycemic control and led to less hypoglycemia in a small, short-term trial of adults and in a separate trial of pre-teens.
“We want a technology that adapts to the spontaneity of life,” said Damiano, who added that the device could change the way type 1 diabetes patients care for themselves until a cure is found. “It does this while simultaneously unburdening people from management decisions and worrying about being wrong.”
Damiano was the first speaker at this year’s AACE conference — probably the first biomedical engineer to lead an AACE conference — said Mack Harrell, MD, the president of AACE.
And he played that novel role well: dressed in black shirt and jeans, he paced the stage, liberally using terms like “synergy” and “integration” and topping his presentation with a high-production-value marketing video that touted the bionic pancreas. He also shared pictures of his son — who at 11 months was diagnosed with type 1 diabetes.
But he also had results from two trials to report. In the first trial, 19 pre-teens at a summer camp in 2014 wore either the device or had normal care for 5 days. In the control group, the mean continuous glucose monitor (CGM) was 168 ± 30 mg/dL; for the group with the device, the mean CGM was 137 ± 11 mg/dL.
The time spent under 60 mg/dL was 2.8% of the time for the control group, and 1.2% for the intervention group. Time over 180 mg/dL was 36% versus 17%.
In the separate trial, Damiano and his colleagues enrolled a group of 38 adults, seven of them in the control group, for 11 days. The patients were at four different medical centers around the country. Those in the control group had a mean CGM of 162 ± 29 mg/dL versus 141 ± 10 mg/dL for the group with the device. Time spent under 60 mg/dL was 1.9% versus 0.6%, and 34% above 180 mg/dL versus 20%.
In both of the studies, the same amount of insulin was used.
The device is an amalgam of several different parts: a Dexcom monitor, two Tandem infusion pumps, and an iPhone accessible algorithm — the user carries the phone. Damiano said he tested kids at summer camp because their active lifestyle would test not only the algorithm, but the durability of the device itself.
“They’re not exactly showing proper respect to this device,” he said.
But Is It Safe?
“You have to realize that there are circumstances in which things can really go wrong,” said Damiano, speaking of the safety and security of the device. “And that you’re dealing with a very vulnerable population.”
In addition to the possibility of glitches or malfunction, app-based medical devices must also worry about cybersecurity. A recent study found that the majority of insulin dosing apps are unreliable and put patients at risk. Nearly a quarter of these apps crashed. Two-thirds carried a risk of giving the wrong dosage recommendations, and there was a lack of transparency with most of the apps. The software on a fully automated bionic pancreas would have to be much more reliable.
And a study by Yogish Kudva, MD, from the Mayo Clinic, and colleagues, found that cybersecurity is not where it should be for artificial pancreases. “We suggest that, to date, the essential concept of cybersecurity has not been adequately addressed in this field,” concluded the authors of that paper.
Damiano said he agreed. “I don’t think in the med device industry that has been handled particularly well,” he said during a press conference here. “We have a lot of strategies for that, but I think we’re really going to have as cybersecure a system as we can hope to have with the technology that there is now.”
He added that they’ve hired a security expert to help them.
The next step is a longer, randomized trial, said Damiano. They are working on a proposal for a year-long study of 480 participants, 160 of whom will belong to a control of usual care. There will be no remote monitoring of the patients, and the primary outcomes will be HbA1c levels and mean CGM levels.
The current plan is to include patients more than 10 years old, said Damiano, though he would like it to be for ages 6 and above. “The FDA is really encouraging us to push that number down,” he said. “They want to test it with as many people as possible. If we do a trial with 2- and 3-year-olds, that’s going to give them peace of mind.”
He said the FDA has been cooperative, contradicting their image that the agency is slow to react.
“They’re taking a very different attitude from what people have expected them to do,” he said. Damiano and his team must build a single device in which all of the components come together in order to move forward. He said that they are working with industry to design the device.
He added that it will be at least 3 years before the device is available. When asked to speculate about the cost, he said it would be slightly more expensive than current devices because it needs two chambers — one for insulin and one for glucagon — at around $8,000 to $9,000.