Memorandum

European Commission grants Cambridge-led group £4.6 million to conduct one-year artificial pancreas trial in 1-7 year olds – September 9, 2016

The University of Cambridge announced earlier this week that the European Commission will contribute £4.6 million to run a year-long trial investigating use of the artificial pancreas in type 1 children ages one to seven – an ambitious study population for sure, but an age group where automation should make a profound difference on glycemic control and quality of life. The study will compare closed loop to “state of the art insulin pump therapy” (we assume sensor-augmented), first in a pilot phase (n=24), and eventually in a main study (n=94) – no start timing was shared for either phase. We’re glad to see a lengthy one-year study duration, and hope this data could support a change in standard-of-care – imagine automated insulin delivery routinely prescribed at diagnosis! The press release does not specify, but commentary at ADA suggested upcoming Cambridge studies will run its MPC algorithm on an Android phone talking to the MiniMed 640G/Enlite 3. Study funding will be delivered through the Commission’s Horizon 2020 program to KidsAP, a collaboration between Cambridge scientists and other institutes in Europe and the US. Cambridge will receive about a third of the grant, £1.6 million, for coordinating the project. We’ve been glad to see the Cambridge team blazing a trail into understudied clinical populations: (i) last month, the group published an impressive study in NEJM showing the benefits of closed-loop in pregnancy, including during labor; and (ii) their closed-loop study in inpatient type 2 diabetes was a compelling highlight at ADA. While these populations are usually tougher to study, the benefit:risk balance is often better too. The FDA has also routinely emphasized that younger age groups are key to study early, since devices will be used off label. Medtronic has begun a pivotal study of the 670G in pediatrics (see it here on ClinicalTrials.gov), though it only stretches down to 7-13 year olds.  

-- By Brian Levine, Adam Brown, and Kelly Close