Last Wednesday, diabetes researchers and advocates from around the country convened in Washington, DC, for an FDA hearing on the Artificial Pancreas with the aim of making this pipe dream a reality. The point of the hearing was to allow JDRF and other stakeholders — researchers, industry reps, and patients — a chance to provide input on the Artificial Pancreas Project, in particular "recommendations to ensure the safe and effective testing of artificial pancreas technology in real-life situations."

To bring you up to speed: various artificial pancreas-like devices have been tested in controlled hospital settings around the country, including clinics at Yale University and Stanford University. But in order to gain FDA approval, the artificial pancreas must be tested safely in "real world" conditions, i.e. in field studies where patients wear the device on a daily basis in their own home environments. In preparation for this hearing, JDRF formed a panel of international D-diabetes experts to make specific recommendations on how these studies can and should be accomplished.

A summary of their preliminary recommendations can be read in PDF format here.

You'll note that the panel gives advice on how to transition from inpatient to outpatient settings for studies — things like establishing "a transition step where each patient demonstrates the ability to operate the system and be responsible for calibration without intervention from medical personnel (who are in close proximity) is advisable before moving to an outpatient setting."

Next, the expert panel talks about which groups of patients should be allowed to participate in such studies: "Otherwise healthy T1D patients experienced with using insulin pumps and continuous glucose monitors, since such patients have the highest likelihood of using the closed-loop system safely. This would then be followed by the study of more clinically relevant populations that may be more likely to benefit."

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But at the end of the day, it's all about safety.

What constitutes a safe artificial pancreas system? you may ask.  Well, Folks, that is the $64 million question — and the one at the heart of this hearing.

All the players are understandably concerned about the risks of a system that could deliver insulin, or stop delivering it, automatically. Because of the potential hazards and the complexity of these systems, the FDA has yet to establish "clear and reasonable" regulatory guidelines for the artificial pancreas, or specific rules for any "automatic" features that might be added to current insulin pump systems. Without guidelines, as you can imagine, it's difficult for any company to present a product to the FDA for evaluation, or even set up a clinical trial that they can be confident would be recognized to that end.

In Europe, Medtronic Minimed has already introduced an insulin pump that includes a "Low Glucose Suspend" feature (its Veo system), which enables the pump to shut off automatically for 2 hours if the attached CGM alarms that blood sugar has reached the patient's "low threshold." But this pump has not yet been approved by the FDA for US distribution, presumably because they see the automatic shut-off as potentially harmful to patients' health.

Another main concern for the FDA is the fact that current CGMs (continous glucose monitoring systems) aren't 100% accurate, so how can they be trusted to determine how much or how little insulin a patient needs? Sounds like a path to a tidal wave of hypoglycemic events, no?

Well, the data from "proof of concept" studies (studies conducted in a very small number of patients to prove whether a product is viable for larger scale studies) is telling another story, according to Dr. Fran Kaufman, Chief Medical Officer of Medtronic Diabetes. Data from 27 patients using the company's Minimed Veo combined with a CGM showed a significant drop in A1C after 6 months, and notably: "There's been no evidence of an increase in hypoglycemia," she says.

But Dr. Patricia Beaston, an endocrinologist and member of the FDA's Artificial Pancreas team, explained her hesitation: "The CGM and meter are part of the system and they have inherent errors. The fact they agree with themselves makes it hard to make any determination. If you look within individual patients, the accuracy of the sensor for the 3-6 days varies across those patients. A lot of it is dependent on how well that patient does the calibrations, how often, and the quality of the glucose meter they use to make those calibrations."

Bruce Buckingham, an endocrinologist at California's Stanford University and Packard Children's Hospital and an investigator into the artificial pancreas, countered those fears, saying, "There's not a very big risk if you turn it off for a couple of hours." He states that in early studies, when the CGM indicated a low when there was none, leading to up to 2 hours of no insulin, the chances of ketones was fairly rare. (Not exactly the most comforting words when you've been on a CGM that seems to alarm for no reason, but for folks with hypoglycemia unawareness or who consistently do sleep through lows, the auto-shut-off system could be a life-saver!)

Finally, John Knight, a professor of computer science at the University of Virginia, offered a metaphor for thinking about the idea of "safety" in inherently "unsafe" machines: When we get into a car or fly in an airplane, we know there is a certain chance that they could stop working and crash, or that something externally could go wrong. But we do it anyway. Why? Because, as Dr. Knight explained, "Safety is defined as an 'acceptable' level of risk."

In his testimony, Dr. Aaron Kowalski, Assistant Vice President of Treatment Therapies at JDRF, seemed to be hinting at the same thing.  "In the hospital setting, these systems display fantastic results. The biggest need is to move these studies to the real world. We need to show these studies, and I'm completely convinced that if we use these systems in the real world, they will show an improvement in efficacy." JDRF has also released a statement on their current thinking about the Artificial Pancreas Project.

By the end of the hearing, four main points were laid out that the FDA and industry need to work out, as presented by Dr. David Klonoff, head of the Diabetes Technology Society*:

The patients who testified — and those of us at home — know that while safety is a priority, there are inherent risks in living on insulin anyway. Some talked about the dangers and fears of nighttime low blood sugars... So is it prudent to wait for the technology to be "perfect"? If it ever will be?

The FDA will be reviewing feedback from the various speakers, and as always, we'll be here to bring you the latest as things develop. Until then, what are your immediate thoughts on the Artificial Pancreas Project and the Low Glucose Suspend? Are you chomping at the bit to get started, or are you in the "slow and steady" camp?

{* Thanks to Crystal for the screen grab!}

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This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn't adhere to Healthline's editorial guidelines. For more information about Healthline's partnership with Diabetes Mine, please click here.