iLet Bihormonal Bionic Pancreas Clinical Trial Begins

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Are two hormones better than one? A new clinical trial aims to find out.

Massachusetts startup Beta Bionics and Danish biotech firm Zealand Pharma have announced the beginning of a clinical trial investigating the home-use of their iLet (get it?) experimental bionic pancreas system. What sets the iLet apart from other artificial pancreas concepts is the use of a second hormone in conjunction with insulin. That second hormone is dasiglucagon, a unique stable liquid glucagon analogue developed by Zealand.

People with Type 1 diabetes should already be well familiar with exogenous glucagon, which is routinely prescribed for emergency treatment of hypoglycemia. The glucagon on the market, a vial of which is hopefully residing in your emergency diabetes kit, requires some work before it can be injected: a diluent and powder must be mixed in the stressful moments before a shot is actually administered. Zealand’s new product is a stable liquid, requiring no such fuss, and early returns are good: a study in Diabetes Care concluded that “dasiglucagon has the potential to become an effective and reliable rescue treatment for severe hypoglycemia in a ready-to-use pen.” Zealand is one of several firms pursuing a ready-to-use glucagon, which would be cause enough for celebration, but today’s news concerns its applicability in an insulin pump.

Most artificial pancreas concepts that we are familiar with can only increase blood sugar in a roundabout way, by suspending insulin uptake or by warning the user to ingest some sugar. The bihormonal approach would allow the iLet system, employing real-time CGM data, to push the user’s blood sugar down or up all by itself. Although the joint press release is not forthcoming with details, we can hope that the dasiglucagon is carefully released in precise microdoses in order to smoothly and incrementally increase the user’s blood sugar, and is not merely a fail-safe option to prevent catastrophic hypos.

ASweetLife is particularly excited by this potential. Previous closed-loop systems, while representing a huge technological leap forward, have frustrated us by only allowing the user to set a relatively high glucose target. Such restrictions were undoubtedly informed by the fear that low targets will result in too many bouts of hypoglycemia. Perhaps the makers of the iLet, which is armed with a more proactive ability to increase blood sugar, will eventually allow users to target a lower and healthier blood sugar.

Beta Bionics also promises that the system harnesses “lifelong machine learning and artificial intelligence” to deliver a fully autonomous system – no carb counting or pre-bolusing necessary. We will await the details as to how exactly they pull that off. The new trial, which will be conducted by Massachusetts General Hospital, represents just one of many hurdles before the makers will be able to bring their bionic pancreas system to market.

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