Certified Interoperability Allows a More Secure Move to theArtificial Pancreas Through a New Concept: Make-It-Yourself

摘要

Type 1 diabetes (T1D) is among the toughest health condition to manage both by theaffected patients and by the healthcare professionals (HCPs) who assist them. Whileevidence-based recommendations are to make all efforts to reach near-normal glucoselevels to prevent long-term complications related to glucose toxicity, recently reportedregistries have shown how few patients with T1D succeed in getting the 7% (53 mmol/mol)A1c target.1,2 The key challenge isto avoid hyperglycemia without increasing hypoglycemia, which has been integrated in theInternational Consensus based on continuous glucose monitoring (CGM) as the goal ofkeeping glucose for more than 70% of time in the 70-180 mg/dL range with less than 4% oftime below 70 mg/dL including less than 1% below 54 mg/dL.3 The variability of insulin needs in daily life results in a “Mission: Impossible”for most human brains to adjust insulin delivery to glucose variations in order tomaintain glucose levels in a safe near-normal range. The availability of increasinglyaccurate glucose sensors for CGM and reliable insulin pumps since the beginning of thesecond millennium has revitalized the concept of automated insulin dosing according tocurrent and predicted glucose changes thanks to control algorithms targeting atclose-to-normal glucose levels.4 Several pioneering consortia of control engineers, digital scientists, anddiabetes clinicians have investigated combinations of CGM systems, insulin deliverydevices, and control algorithms from the secured hospital environment to real-lifeconditions which allowed demonstrations of safe, effective, and usable closed-loopglucose control. Improvements included increased time in the 70-180 mg/dL glucose range,reduced time in hypoglycemia, lower average glucose and A1c levels, and reduced diabetescare burden.5 Recently reported trial results showed close to 80% time in range at night-time,a time period during which hypoglycemia is highly feared.6,7 Nevertheless, full automation doesnot allow optimal control at mealtime due to delayed action of subcutaneously deliveredinsulin, resulting in the concept of “hybrid” closed-loop systems with mealannouncements for anticipated insulin bolus before food intakes.8 Due to the needed safe connections between the devices to minimize the risk oflosing the signal between CGM, algorithm, and insulin infuser, closed-loop systems,commonly designated as “artificial pancreas” (AP), have been locked through specificcommunication codes. In September 2016, the US Food and Drug Administration (FDA) gavethe approval to sell the first hybrid closed-loop automated insulin delivery device, theMiniMed 670G, for people with T1D.9 Of note, for the sake of safety, patients needed to calibrate sensor signal 4times per day and correction bolus were not included in the algorithm features. Annoyingsensor alarms and frequent exits of auto mode have somewhat disappointed early adoptersas recently reported.10