Abstract
INTRODUCTION: A post hoc analysis from a 90-day proof-of-concept study demonstrated increased efficacy and no new safety concerns for an ultra-rapid-acting inhaled insulin, Technosphere(®) Insulin (TI), when a higher modified conversion dose was compared to the conversion dose in the current US prescribing insert (approx. 2 × vs approx. 1.3 × TI per rapid-acting insulin analogue [RAA] unit [U] across the 1-24 U range). This post hoc analysis evaluates the safety and efficacy of the modified conversion dose in the postprandial period. METHODS: Participants with type 1 diabetes (T1D) were randomly assigned to administer TI using the modified dosing (TI group) or continue using their automated insulin delivery (AID) system (AID controls) in this in-clinic standardized meal challenge. Postprandial glucose was measured via capillary self-monitored blood glucose over 2 h post-meal to evaluate mean peak glucose and mean peak glucose excursion. RESULTS: The TI group (n = 21) demonstrated faster and lower mean peak glucose and mean peak glucose excursion vs AID controls (n = 5). Mean peak glucose and glucose excursion were reached 30 min earlier with TI. One TI + AID participant (modified dose) experienced one level 1 hypoglycemia event in the 2-h postprandial period and recovered in-clinic. No serious adverse events were reported. CONCLUSIONS: TI group demonstrated a more favorable glycemic response in the 2-h postprandial period vs AID control. Data from this and previous studies suggest this higher modified conversion TI dose from subcutaneous RAA may help further reduce postprandial hyperglycemia in T1D. TRIAL REGISTRATION: ClinicalTrials.gov NCT05243628.