Imagine being able to inhale insulin at mealtime to manage your blood sugar levels rather than having to inject insulin multiple times a day to control your diabetes.
If you’re older than 18, you don’t have to imagine. Afrezza, an inhalable insulin made by pharmaceutical manufactuer MannKind, has been available since 2014.
But children with diabetes may get to have access to the same inhaled insulin product as adults to maintain their health, thanks to a new and ongoing study being conducted at Seattle Children’s Hosptial and nearly 40 other research institutions across U.S.
INHALE-1 study
“INHALE-1 is a research study that is evaluating the safety of an inhaled insulin product and how well it works in children and teenagers with diabetes,” says Dr. Faisal Malik, a pediatric endocrinologist at Seattle Children’s Hospital and lead site investigator for the INHALE-1 study here. “Positive results may mean that the inhaled insulin product could also be approved to be used in youth with diabetes.”
The study, INHALE-1, is now recruiting kids with diabetes between the ages of 4 and 17 in the Seattle area. They will join more than 250 patients nationwide expected to be enrolled in the study.
If study results show the inhaled form of insulin is safe for children and Afrezza wins approval from the Federal Food and Drug Administration for use in children, kids may be able to say goodbye to daily insulin injections for meals or correction of high blood sugar levels. The noninvasive inhaler fits in the palm of the hand. To use it, small cartridges are simply clicked into place and inhaled.
WA kids living with diabetes
The Washington State Department of Health estimates that close to 3,000 children (1 in 550) in the state are living with the disease. Malik estimates that more than 2,000 children and youth with diabetes from all over Washington State receive diabetes care at Seattle Children’s Hospital.
How can join the study
Malik says the study is currently enrolling youn patients ages 4 to 17 with Type 1 or Type 2 diabetes. To be eligible for enrollment, participants must:
- Currently be using mealtime insulin (via vial or insulin pen, no insulin pumps)
- Have an A1c level between 7% and 11%
- Have no recent history of asthma (treated within the last 12 months) or other lung conditions
- Have no history of smoking (cigarettes, marijuana, or vape) within the last 6 months
What’s involved
The INHALE-1 study involves clinic visits, blood draws, and lung function tests. Participants will either take inhaled insulin for 12 months or continue using their mealtime injectable insulin for six months before switching to inhaled insulin for six months. Kids in the study need to use a continuous glucose monitor (CGM) provided by researchers to monitor their blood sugar levels during the study.
Inhaled insulin and some compensation will be provided free to participants.
Kids deserve options
Malik says he holds hope that the study will give kids living with diabetes more comfortable options for maintaining their health.
“As a researcher, I am dedicated to improving patient health and health care quality for youth and young adults with diabetes,” he says. “I strongly believe our younger generation living with diabetes deserve as many treatment options as possible so that they and their doctor can choose which regimen will work best for them.”
Enrollment is still underway at Seattle Children’s. Learn more by contacting Britney Ellisor, 206-884-1809, IDOlab@seattlechildrens.org or visiting mannkindcorp.com/inhale1/ or clinicaltrials.gov.
