- In 2006, the JDRF Artificial Pancreas project began, and in 2009 the JDRF outlined a 6 step-wise roadmap to development, refinement, and regulatory approval of a subcutaneous glucose monitoring and subcutaneous insulin delivery artifi- cial pancreas system.44,45 This roadmap described successive steps from SAP therapy to systems involving sensor-directed suspension of insulin delivery to systems of hybrid and full closed-loop therapy and finally multihormone (eg, insulin and glucagon) therapy. Data exist on all steps of the 2009 roadmap summarized in this section, which demonstrate the feasibility of each.46-55 Therefore, an updated roadmap has been introduced by Kowalski55 to emphasize a bifurcated pathway to insulin only and bihormonal insulin systems. The Food and Drug Administration also has issued updated guidelines specifically for artificial pancreas development with an attempt to achieve “the least burdensome approach” toward artificial pancreas testing and approval.56 They recommend that artifi- cial pancreas systems be studied in 2 phases: first feasibility and then pivotal studies. Feasibility studies are underway and being completed at the time of this writing and pivotal studies are under design and implementation.
- At the present time a step-1 commercial device (the Medtronic 530G system) with Threshold Suspend is available in the US and is helpful for patients with overnight hypoglycemia. This system successfully reduced overnight hypoglycemic events without producing rebound hyperglycemia in a recent phase 4 study.57 A step-2 commercial device (the Medtronic 640G system) with predictive low-glucose suspend was approved in Australia and in Europe. Initial studies that use a different predictive low glucose suspend algorithm have shown substantial reduction in overnight hypoglycemia in patients as young as 4 years of age.48,49,58 Step-3 devices with combined hypoglycemia and hyperglycemia minimizers are currently under phase 3 study
Dr. Jayaprakash
Superintendent, ICH.
Institute of Child Health.
Gov. Medical College Kottayam.
Kerala, India.