Background: Glucose variability (GV) remains a key limiting factor in the success of diabetes management. While new technologies, for example, accurate continuous glucose monitoring (CGM) and connected insulin delivery devices, are now available, current treatment standards fail to leverage the wealth of information generated. Expert systems, from automated insulin delivery to advisory systems, are a key missing element to richer, more personalized, glucose management in diabetes.
Methods: Twenty four subjects with type 1 diabetes mellitus (T1DM), 15 women, 37 ± 11 years of age, hemoglobin A1c 7.2% ± 1%, total daily insulin (TDI) 46.7 ± 22.3 U, using either an insulin pump or multiple daily injections with carbohydrate counting, completed two randomized crossover 48-h visits at the University of Virginia, wearing Dexcom G4 CGM, and using either usual care or the UVA decision support system (DSS). DSS consisted of a combination of automated insulin titration, bolus calculation, and CHO treatment advice. During each admission, participants were exposed to a variety of meal sizes and contents and two 45-min bouts of exercise. GV and glucose control were assessed using CGM.
Results: The use of DSS significantly reduced GV (coefficient of variation: 0.36 ± 08. vs. 0.33 ± 0.06, P = 0.045) while maintaining glycemic control (average CGM: 155.2 ± 27.1 mg/dL vs. 155.2 ± 23.2 mg/dL), by reducing hypoglycemia exposure (%<70 mg/dL: 3.8% ± 4.6% vs. 1.8% ± 2%, P = 0.018), with nonsignificant trends toward reduction of significant hyperglycemia overnight (%>250 mg/dL: 5.3% ± 9.5% vs. 1.9% ± 4.6%) and at mealtime (11.3% ± 14.8% vs. 5.8% ± 9.1%).
Conclusions: A CGM/insulin informed advisory system proved to be safe and feasible in a cohort of 24 T1DM subjects. Use of the system may result in reduced GV and improved protection against hypoglycemia.
Keywords: Continuous glucose monitoring; Decision support systems; Expert systems; Insulin titration.; Treatment advisory systems; Type 1 diabetes.