A 13-Week Single-Arm Evaluation of Inhaled Technosphere Insulin Plus Insulin Degludec for Adults with Type 1 Diabetes.

Background: Inhaled technosphere insulin (TI, Afrezza®) has a more rapid onset of action than rapid-acting insulin analogs (RAA). Methods: Forty-nine adults with type 1 diabetes (T1D) initiated a regimen of TI plus insulin degludec for 13 weeks after completing 17 weeks in the usual-care control group of a randomized trial. The initial TI dose, based on bioequivalence, was approximately two times the RAA dose being used. The primary outcome was noninferiority for daytime time-in-range (TIR) 70-180 mg/dL at 13 weeks. Results: During the preceding 17-week period (baseline), 41% of the 49 participants were using automated insulin delivery (AID), 6% a predictive-low-glucose-suspend pump, 4% a sensor-augmented pump (SAP), and 49% multiple daily injections (MDI) plus continuous glucose monitoring. Daytime TIR increased from 50% ± 17% at baseline to 55% ± 20% after 13 weeks (mean change 5.1%, 95% confidence interval [CI]: 0.3% to 9.8%, noninferiority P < 0.001, superiority P = 0.04), with an increase of 8.6% compared with baseline MDI/SAP and no change compared with baseline AID. Mean HbA1c change from baseline was -0.23% (95% CI: -0.42% to -0.04%, noninferiority P < 0.001, superiority P = 0.02), with mean change of -0.36% compared with MDI/SAP and 0.0% compared with AID. Participants meeting the HbA1c target of <7.0% increased from 14% to 31% (P = 0.02). Among baseline AID users, overnight TIR decreased by 15.6% when switched to TI-degludec, whereas among baseline MDI/SAP users, overnight TIR increased by 2.0%. Mean time <54 mg/dL was 0.5% ± 0.7% at baseline and 0.7% ± 0.8% after 13 weeks (mean change 0.2%, 95% CI: -0.1% to 0.5%). After 13 weeks, 40% of participants indicated a desire to continue using TI. Conclusions: In adults with T1D, glycemic outcomes were comparable or slightly better with TI-degludec after switching from AID or MDI. TI should be considered as an option for individuals who want an alternative to using an insulin pump or MDI for insulin delivery.