Adaptive bio-behavioral control: A pilot analysis of human-machine co-adaptation in type 1 diabetes.

BACKGROUND While it is well recognized that an automated insulin delivery (AID) algorithm should adapt to changes in physiology, it is less understood that the individual would also have to adapt to the AID system. The adaptive bio-behavioral control (ABC) method presented here attempts to compensate for this deficiency by including AID into an information cloud-based ecosystem. METHODS The Web Information Tool (WIT) implements the ABC concept via: (1) A Physiological Adaptation Module (PAM) that tracks metabolic changes and adapts AID parameters accordingly, and (2) a Behavioral Adaptation Module (BAM) that provides information feedback. The safety of WIT (primary outcome) was assessed in an 8-week randomized, two-arm parallel pilot study. All participants used the Control-IQ® AID system enhanced with PAM, but only those in the Experimental group had access to BAM. Secondary glycemic outcomes were computed using the 2-week baseline period and the last 2 weeks of treatment. RESULTS Thirty participants with type 1 diabetes (T1D) completed all study procedures (17F/13M; age: 40±14y; HbA1c: 6.6%±0.5%). No severe hypoglycemia, DKA, or other serious adverse events were reported. Comparing Experimental and Control groups, no significant difference was observed in time in range (70-180 mg/dL): 74.6% vs 73.8%, adjusted mean difference: 2.65%, 95%¬¬¬¬¬CI (-1.12%,6.41%), P=0.161. Time in 70-140 mg/dL was significantly higher in the Experimental group: 50.7% vs 49.2%, 5.71% (0.44%,10.97%), P=0.035, without increased time below range: 0.54% (-0.09%,1.17%), P=0.089. CONCLUSION The results demonstrate it is safe to integrate an AID system into the WIT ecosystem. Validation in a full-scale study is ongoing.