Artificial pancreas race heats up with new Medtronic ASPIRE data

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Medtronic has taken another step towards developing the highly-anticipated “artificial pancreas” by presenting new results from the ASPIRE study of its Threshold Suspend technology, which is used with its insulin pumps. The results were reported at the annual meeting of the American Diabetes Association (ADA), as well as appearing online in the New England Journal of Medicine on 22 June.

If it reaches the clinic, an artificial pancreas would spell the end of lifestyle-encumbering blood glucose tests and insulin injections for diabetic patients, by measuring glucose levels and automatically adjusting insulin dose accordingly. Medtronic is vying with rivals including Animas, part of Johnson & Johnson, which reported results from a 20-patient feasibility study of its Hypoglycemia-Hyperglycemia Minimizer (HHM) first-generation closed-loop system at the ADA meeting on 21 June (www.clinica.co.uk, 24 June 2013).

The latest results from Medtronic’s ASPIRE (Automation to Simulate Pancreatic Insulin Response) In-Home trial came from 247 patients with type 1 diabetes and documented nocturnal hypoglycemia, who were randomly assigned to receive a MiniMed sensor-augmented insulin-pump therapy with (121 patients) or without (126 patients) the Threshold Suspend feature for three months.

The Threshold Suspend function is designed to halt insulin delivery when glucose levels become too low, protecting patients against the risk of hypoglycemia. This is a common complication of insulin therapy that can lead to confusion, seizures and, in severe cases, death. If glucose levels drop below 70mg/dl, the feature suspends insulin delivery for up to two hours, long enough for levels to recover while minimizing the risk of rebound hyperglycemia. Patients can resume insulin delivery at any time, or can take action to correct the low insulin level, such as eating or drinking.

Threshold Suspend is just one component of the so-called artificial pancreas – the latter would also need to be able to sense when glucose levels are too high, and create a closed-loop system in which insulin delivery and dose is determined by a patient’s glucose level.

Threshold Suspend is not yet available in the US, where it is part of the MiniMed 530G, which is currently under review by the FDA. Morgan Stanley analyst David Lewis has previously estimated that the device could get the go-ahead in the first quarter of fiscal 2014 (www.clinica.co.uk, 17 May), which could be any time soon: Medtronic reported fiscal Q4 and full-year 2013 results in May (www.clinica.co.uk, 21 May 2013).

The technology has been available in Europe since 2009, when Medtronic CE marked its Paradigm Veo insulin pump with low glucose suspend technology – another name for Threshold Suspend.

Check back next week for part 2, which includes the results!