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Inhaled Technosphere Insulin in Children with Diabetes: The INHALE-1 Extension Study
Roy W Beck1, Lauren Kanapka1, Roshanak Monzavi2
1JAEB Center for Health Research, Tampa, Florida, USA.
Diabetes Technology & Therapeutics
|February 5, 2026
Summary
The INHALE-1 extension study found technosphere insulin (TI) safe for children with diabetes over 52 weeks. While HbA1c slightly increased, TI offers a viable option for pediatric patients, especially those avoiding AID systems.
Area of Science:
- Pediatric Endocrinology
- Diabetes Management
- Pharmacology
Background:
- The INHALE-1 trial assessed technosphere insulin (TI) in children with diabetes.
- An extension phase was conducted to gather long-term safety data for TI.
Purpose of the Study:
- To evaluate the long-term safety and efficacy of technosphere insulin (TI) in pediatric patients with diabetes.
- To provide extended safety data following the initial INHALE-1 randomized controlled trial.
Main Methods:
- Children aged 4-17 with type 1 or type 2 diabetes were randomized to TI or rapid-acting analog (RAA) plus basal insulin and CGM.
- Participants could enter a 52-week extension phase, using TI in both groups.
Main Results:
- No serious pulmonary adverse events were reported with TI use.
- HbA1c levels showed a slight deterioration (0.38% in TI group, 0.31% in RAA crossover group) from 26 to 52 weeks.
- Continuous glucose monitoring showed minimal time below 54 mg/dL during TI use.
Conclusions:
- The INHALE-1 extension phase confirmed no safety concerns with TI in pediatric diabetes patients.
- TI may be a beneficial treatment option for children with diabetes, particularly those unable or unwilling to use automated insulin delivery (AID) systems.
- Despite a slight increase in HbA1c, TI's safety profile and reported patient satisfaction suggest its utility.
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