Adaptive Biobehavioral Control: A Pilot Analysis of Human-Machine Coadaptation in Type 1 Diabetes.

ABSTRACT

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 biobehavioral 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 the following (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 (17 female/13 male; age 40 ± 14 years; HbA1c 6.6% ± 0.5%). No severe hypoglycemia, DKA, or other serious adverse events were reported. Comparing the 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 that it is safe to integrate an AID system into the WIT ecosystem. Validation in a full-scale study is ongoing.