Related Experiment Video

Updated: Jan 11, 2026

Author Spotlight: Exploring the Impact of Reduced Resistance Exercise Volume on Metabolic Health
06:13

Author Spotlight: Exploring the Impact of Reduced Resistance Exercise Volume on Metabolic Health

Published on: December 1, 2023

1.6K

INHALE-1: A Multicenter Randomized Trial of Inhaled Technosphere Insulin in Children With Type 1 Diabetes

Michael J Haller1, Lauren Kanapka2, Roshanak Monzavi3

  • 1Department of Pediatrics, University of Florida, Gainesville, FL.

Diabetes Care
|November 12, 2025
PubMed

Insights

Inhaled technosphere insulin (TI) did not meet noninferiority for HbA1c in children with diabetes. However, TI was safe, improved treatment satisfaction, and reduced weight gain compared to rapid-acting analog insulin.

Area of Science:

  • Pediatric Endocrinology
  • Diabetes Management
  • Pharmacology

Background:

  • Type 1 diabetes is a chronic condition requiring lifelong insulin therapy.
  • Optimizing insulin delivery methods is crucial for improving glycemic control and patient quality of life.
  • Inhaled insulin presents a potential alternative to injectable insulin formulations.

Purpose of the Study:

  • To assess the efficacy and safety of inhaled technosphere insulin (TI) compared to rapid-acting analog (RAA) insulin in pediatric patients with diabetes.
  • To evaluate TI's impact on glycemic control, specifically HbA1c levels and time in range (TIR).
  • To determine the safety profile of TI, including pulmonary function and adverse events.

Main Methods:

  • A randomized controlled trial involving 230 youth (4-17 years) with type 1 diabetes.
  • Participants were assigned to receive either TI or RAA insulin for 26 weeks, alongside basal insulin and continuous glucose monitoring (CGM).
  • The primary outcome was the change in HbA1c, with noninferiority testing against a 0.4% margin.

Main Results:

  • The primary analysis did not achieve noninferiority for HbA1c change between TI and RAA groups (P = 0.091).
  • CGM-measured time in range (70-180 mg/dL) showed no significant difference between the groups (P = 0.38).
  • The TI group reported higher treatment satisfaction (P = 0.004) and experienced less weight and BMI percentile gain (P = 0.009).

Conclusions:

  • Inhaled technosphere insulin did not meet the noninferiority criteria for HbA1c in pediatric patients with diabetes.
  • TI demonstrated a favorable safety profile over 26 weeks, with no adverse effects on pulmonary function.
  • TI offers a potentially valuable treatment option for select pediatric patients with type 1 diabetes, enhancing satisfaction and mitigating weight gain.
Abstract

More Related Videos

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

11.1K
Intraperitoneal Glucose Tolerance Test, Measurement of Lung Function, and Fixation of the Lung to Study the Impact of Obesity and Impaired Metabolism on Pulmonary Outcomes08:30

Intraperitoneal Glucose Tolerance Test, Measurement of Lung Function, and Fixation of the Lung to Study the Impact of Obesity and Impaired Metabolism on Pulmonary Outcomes

Published on: March 15, 2018

14.6K

Related Concept Videos

Insulin: Dosing Regimen and Adverse Effects01:16

Insulin: Dosing Regimen and Adverse Effects

Insulin-replacement therapy usually includes both long-acting insulin (basal) and short-acting insulin (to cater to postprandial needs). In a diverse group of type 1 diabetes patients, the average daily insulin dose is typically 0.5-0.7 units/kg body weight. However, obese patients and pubertal adolescents may need more due to insulin resistance.
The basal dose constitutes about 40%-50% of the total daily dose, with the rest as premeal insulin. The mealtime insulin dose should mirror...
665
Insulin Formulations: Types and Delivery01:27

Insulin Formulations: Types and Delivery

Insulin preparations are categorized by their duration of action into short-acting and long-acting types. Two strategies are used to modify insulin's absorption and pharmacokinetic profile: slowing the absorption post-subcutaneous injection, or altering human insulin's amino acid sequence or protein structure. These changes retain the insulin's ability to bind to the insulin receptor, but alter its behavior in solution or after injection.
Short-acting insulins are divided into...
632
Inhaled Medications01:23

Inhaled Medications

Inhaled medications are crucial for managing chronic obstructive pulmonary disease (COPD) and asthma. They are essential for effective treatment and control, ensuring optimal respiratory health and well-being. Inhaled medication delivers drugs directly to the lungs, providing a rapid onset of action and reducing systemic side effects compared to oral or injectable medications. Three primary types of inhalation devices are used to administer these medications: nebulizers, metered-dose inhalers...
717
Diabetes Mellitus: Overview and Type I Subtype01:22

Diabetes Mellitus: Overview and Type I Subtype

Diabetes mellitus is a chronic metabolic disorder characterized by high blood glucose levels due to inadequate insulin production, insulin resistance, or both. The condition affects millions worldwide and can significantly impact their health and quality of life.
Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. As a result, the body is unable to produce sufficient insulin, and individuals with...
4.8K