Insulin sensitivity (SI) fluctuations, e.g. driven by physical activity and exercise, complicate insulin dosing and worsen glycemic control in individuals with type 1 diabetes (T1D). At last-year ATTD, we presented in-silico results demonstrating the benefit of using an SI-informed bolus calculator to account for exercise-induced SI changes. This year, we present the results from the first clinical deployment of the SI-informed system.
Fifteen subjects with T1D (male/female:10/5, age:45.1±12.6years, HbA1c:6.9±0.9%) using continuous glucose monitor (CGM) and insulin pump completed a 4-week at-home data collection, followed by two 24-hour hotel admissions. During the admissions, participants engaged into a 45-minute early-afternoon aerobic exercise session, after which they received a standardized dinner meal. The dinner bolus was computed using a standard or SI-informed bolus calculator; the latter modulates the insulin dose according to the deviation between usual SI estimated from historical data and real-time SI. Postprandial glycemic control was assessed by CGM-based low/high blood glucose indices (LBGI/HBGI) and percent time outside 70-180mg/dL, and compared between the two admissions.
A 31% exercise-induced SI increase was observed (p=0.0002). The corresponding bolus modulation allowed to reduce postprandial hypoglycemia (ΔLBGI=(–)1.3, p=0.006; ΔPERC<70=(–)6.7%, p=0.049), without significant increase in hyperglycemia (ΔHBGI=1, p=0.075; ΔPERC>180=2.8%, p=0.5) [see figure]; the total number of administered hypoglycemia treatments was reduced from 12 to seven. Sensor glucose at dinnertime did not differ between the admissions (ΔCGM,DINN=(–)0.7mg/dL, p=0.925).
This pilot study shows the safety and efficacy of using the proposed SI-informed bolus calculator in individuals with T1D. Future studies will be devoted to further testing the method.