For some adults who use inhaled insulin at mealtimes, it provides another option to manage their diabetes and it is taken with the first bite of food. But it’s only available for people who are 18+ years old. Children and most teens do not currently have this option. The results of a clinical trial recruiting participants may change that.
Younger kids may be unable to understand diabetes and effectively manage their blood sugar. For tweens and teens, managing diabetes can add an extra layer of stress, particularly when it comes to meals and snacks. Hormonal changes during these years make glucose levels unpredictable, and adolescents tend to eat more meals away from home and are “likely to engage in eating as a major social event with peers.”1
Stopping for a snack after school, participating in a classroom party, eating a mid-morning snack; this could be managed by taking injected insulin about 15-20 minutes before eating or drinking. But children and teens don’t always plan ahead (their executive functioning skills are still developing). They can eat randomly, without time for preplanning insulin doses.
But what if it was safe and effective to take a rapid-acting inhaled insulin just as they start eating? The INHALE-1 clinical trial is finding out.
This study aims to evaluate the safety and effectiveness of a rapid-acting inhaled insulin product for use in children and teenagers with diabetes.
Who Can Join?
- Children and teenagers ages of 4-17
- Diagnosed with type 1 or type 2 diabetes and using mealtime insulin (vial or pen, no pumps)
- A1c is 7%-11%
- No recent history of asthma (in the last 12 months) or other lung conditions
- No smoking or vaping
What’s Involved?
- The study involves clinic visits, blood draws, and lung function tests
- Qualified participants will either take inhaled insulin for 12 months or continue mealtime injectable insulin for 6 months and then switch to inhaled insulin for the final 6 months
- Inhaled insulin will be provided at no cost
- Participants will be asked to check their glucose level frequently using a continuous glucose monitor (CGM), which will be provided throughout the study
Where Is It Recruiting?
Recruitment is taking place, as of now, at 22 sites located in California, Florida, Georgia, Idaho, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Nevada, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Texas. Find the site location nearest you on the National Institutes of Health’s (NIH) ClinicalTrials.gov website.
If you and your child or teen are interested in becoming involved, contact 1-844-INHALE1 or visit INHALE-1.
Facebook Live Event
To learn more about the INHALE-1 clinical trial, you can also watch our Facebook Live event titled “Children are Not Little Adults: The Importance of Pediatric Research,” featuring:
- Anastasia Albanese-O’Neill, Ph.D., APRN, CDCES, Director, Community Screening and Clinical Trial Education, Breakthrough T1D
- Nicole and Sydney Thomas
- Michael J. Haller, M.D., Professor and Chief of Pediatric Endocrinology, University of Florida, and INHALE-1 Protocol Chair
This educational content is made possible with support from MannKind Corporation. Breakthrough T1D produces this content to provide information to our supporters about their potential options for managing their T1D and not as an endorsement of products. Editorial control rests solely with Breakthrough T1D.
1Borus JS, Laffel L. Adherence challenges in the management of type 1 diabetes in adolescents: prevention and intervention. Curr Opin Pediatr. 2010 Aug; 22 (4): 405-11. doi: 10.1097/MOP.0b013e32833a46a7.
