PRE-QUALIFICATION FORM

Who Can Join?

  • Children and teenagers between ages 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 history of smoking (cigarettes, marijuana, or vape) within the last 6 months
PRE-QUALIFICATION FORM

Important Safety Information

  • Inhaled insulin is a man-made human insulin that is breathed-in through your lungs (inhaled) and is used to control high blood sugar in adults with diabetes mellitus. It is not approved for use in children.
  • Inhaled insulin can cause serious side effects, including sudden lung problems (bronchospasms). Do not use inhaled insulin if you have long-term (chronic) lung problems such as asthma or chronic obstructive pulmonary disease (COPD). Before starting inhaled insulin, your study doctor will give you a breathing test to check how your lungs are working.
  • Inhaled insulin is not for use in place of long-acting insulin. Inhaled insulin must be used with basal insulin in people who have type 1 diabetes mellitus.
  • Inhaled insulin is not for use to treat diabetic ketoacidosis.
  • It is not known if inhaled insulin is safe and effective for use in people who smoke. Inhaled insulin is not for use in people who smoke or have recently stopped smoking (less than 6 months).
  • INHALE-1 aims to look at how safe inhaled insulin is and how well it works in children ages 4-17 who have type 1 and insulin-requiring type 2 diabetes mellitus.

What’s Involved in the Study?

  • The study involves clinic visits, blood draws, and lung function tests
  • Qualified participants will either take investigational inhaled insulin for 12 months or continue mealtime injectable insulin for 6 months and then switch to investigational inhaled insulin for 6 months
  • Investigational inhaled insulin will be provided at no cost
  • Participants will be asked to check their glucose level frequently using a study provided continuous glucose monitor (CGM)
  • Compensation will be available and a CGM will be provided throughout the study
PRE-QUALIFICATION FORM

Study Locations

Use the interactive map below to see if there is a site near you. To identify the site nearest you, simply enter your zip code in the search field below. If you are interested in learning more, you can contact the site directly or submit your information here.

  • 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 6 months
  • Inhaled insulin will be provided at no cost
  • Participants will be asked to check their glucose level frequently using a study provided continuous glucose monitor (CGM)
  • Compensation will be available and a CGM will be provided throughout the study.
PRE-QUALIFICATION FORM

Frequently Asked Questions

The following are some frequently asked questions (FAQ'S) about INHALE-1.

  • 1. Why is this study being done?

    The study is being done to find out if inhaled insulin plus basal insulin injections work as effectively and safely as taking all insulin by injections in children and teenagers with diabetes. Inhaled insulin was FDA-approved for use in adults in 2014.

  • 2. How do I know if my child/teenager qualifies for the study?

    You can evaluate your child/teenager’s eligibility by entering his/her information into the pre-qualification form. You can also review the eligibility criteria listed on ClinTrials.gov (https://www.clinicaltrials.gov/study/NCT04974528?term=inhale-1&rank=1).

  • 3. What are some of the benefits from participating in the study?

    The research may help people with diabetes in the future. Your child/teenager may need fewer injections for their diabetes management. A CGM will be provided to participants for use in the study at no cost.

  • 4. What are the most common side effects from using inhaled insulin?

    The most common and expected side effects and discomforts reported for inhaled insulin are low blood sugar, cough, and sore throat.

  • 5. Is my child/teenager eligible for the study if he/she is currently using an insulin pump?

    Your child/teenager is eligible for the study once he/she has been off an insulin pump for at least 2 weeks. Please talk to a health care provider before stopping your child's insulin pump.

  • 6. How do I know if there is a clinical site near me?

    There are currently over 35 active sites across the US! You can find a list of sites on this webpage in the Study Locations section or on ClinTrials.gov (https://www.clinicaltrials.gov/study/NCT04974528?term=inhale-1&rank=1). Additionally, you can enter information into the pre-qualification form and you will be paired with a nearby site. If a nearby site is not immediately available, enter your information anyway and you will be contacted once a nearby site becomes available.

  • 7. Where can I find more details on the study?

    You can review more details on the study by going to ClinTrials.gov (https://www.clinicaltrials.gov/study/NCT04974528?term=inhale-1&rank=1).

PRE-QUALIFICATION FORM

Resource

"Children Are Not Little Adults: The Importance of Pediatric Research” - JDRF and MannKind Corporation discuss the importance of pediatric type 1 diabetes (T1D) research from both the patient and clinician perspective.

Click here to read JDRF’s blog – “The Innovative Insulin Your Kids Can’t Use…Yet – JDRF provides a summary of the INHALE-1 trial".

See if you and your child pre-qualifies for participation in the INHALE-1 Study