Effect of Afrezza on glucose dynamics during HCL treatment
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Methods: We conducted an inpatient, three-way, randomized crossover standardized meal study to assess the efficacy and safety of Afrezza at a low (AL) and a high (AH) dose as compared to a standard SC rapid-acting insulin (aspart) pre-meal bolus during Diabetes Assistant (DiAs) HCL treatment. Participants received two sequential meals on three study days, and pre-meal insulin bolus was determined based on home insulin to carbohydrate ratio for each meal (rounded up to the closest available Afrezza cartridge dose for AH and down for AL). The primary efficacy outcome was the peak postprandial plasma glucose (PPG) level calculated by pooling data for up to four hours after the start of each meal. Secondary outcomes included hyperglycemic, hypoglycemic, and euglycemic venous glucose metrics.
Results: The mean PPG for the rapid acting insulin control arm and AH were similar (185±50mg/dL vs. 195±46mg/dL, respectively; p=0.45), while it was higher for meals using AL (208±54mg/dL, p=0.04). The AH achieved significantly lower early PPG level than the control arm (30 min; p<0.001), and improvement in PPG waned at later time points (120 and 180 min; p=0.02) coinciding with the end of Afrezza glucodynamic action.
Conclusions: Afrezza (AH) pre-meal bolus reduced the early glycemic excursion and improved PPG during HCL compared to aspart pre-meal bolus. The improvement in PPG was not sustained after the end of Afrezza glucodynamic action at 120min.