A Randomized Trial Comparing Inhaled Insulin Plus Basal Insulin Versus Usual Care in Adults With Type 1 Diabetes

Area of Science:

• Endocrinology
• Metabolic Diseases
• Pharmacology

Background:

• Type 1 diabetes management often involves complex insulin regimens.
• Automated insulin delivery (AID) systems and multiple daily injections (MDI) with continuous glucose monitoring (CGM) are common treatment modalities.
• Optimizing glycemic control, particularly postprandial hyperglycemia, remains a key challenge.

Purpose of the Study:

• To evaluate the efficacy and safety of inhaled Technosphere insulin (TI) in combination with insulin degludec.
• To compare this novel regimen against usual care (UC) in adults with type 1 diabetes.
• To assess the impact on glycemic control, specifically HbA1c levels.

Main Methods:

• A 17-week randomized controlled trial involving 123 adults with type 1 diabetes.
• Participants were assigned to either TI plus insulin degludec or UC (continuing their prestudy AID or MDI regimen).
• HbA1c levels were measured at baseline and at the end of the study.

Main Results:

• The TI plus insulin degludec regimen was noninferior to UC in maintaining HbA1c levels (adjusted difference 0.11%, P=0.01 for noninferiority).
• A greater proportion of participants in the TI group showed an improvement in HbA1c (>0.5%) compared to the UC group (21% vs 5%).
• The most frequent side effect was transient cough, leading to discontinuation in eight participants.

Conclusions:

• Inhaled Technosphere insulin combined with insulin degludec is a viable noninferior option for type 1 diabetes management.
• This regimen may be particularly beneficial for individuals aiming to reduce postprandial hyperglycemia.
• Further consideration of TI is warranted for type 1 diabetes patients motivated to improve glycemic control.