Inhaled Insulin for Type 1 Diabetes
(INHALE-AIDEx Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether inhaled insulin (Technosphere Insulin) offers a safer and more effective option than insulin delivered through a pump for individuals with type 1 diabetes who exercise after meals. The study compares inhaled insulin to rapid-acting insulin pumps to assess their performance in managing blood sugar during physical activity. It suits adults with type 1 diabetes who use specific Tandem insulin pumps and regularly engage in moderate or vigorous exercise. Participants must have used their current insulin pump system for at least 90 days and should not have a history of lung issues like asthma. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes research and potentially improve exercise management for others with type 1 diabetes.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use inhaled insulin, non-insulin glucose-lowering medications, or certain other medications that affect glucose metabolism. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Technosphere insulin, the inhaled insulin under study, has undergone previous testing. In a 24-week study, it effectively lowered blood sugar levels in people with type 1 diabetes, without identifying any new safety issues.
Another study highlighted potential benefits of Technosphere insulin, such as weight loss, though researchers noted the need for more information to understand its long-term safety.
In summary, current studies suggest that Technosphere insulin is generally safe and well-tolerated, but further research is necessary to fully understand its long-term safety.12345Why are researchers excited about this trial?
Unlike the standard insulin injections or pumps used for managing Type 1 Diabetes, Technosphere Insulin is unique because it is inhaled, offering a needle-free option for meal-time insulin delivery. This method not only simplifies the process but also acts rapidly, potentially providing better blood sugar control after eating. Researchers are excited because this could mean fewer daily injections and a more convenient lifestyle for people with diabetes, without compromising on effectiveness.
What evidence suggests that inhaled insulin might be an effective treatment for type 1 diabetes?
Research has shown that inhaled Technosphere insulin (TI), which participants in this trial may receive, can help manage blood sugar levels for people with type 1 diabetes. Studies have found that TI lowers HbA1c, a measure of average blood sugar, as effectively as injected insulin. Additionally, people using TI tend to gain less weight, which can be beneficial. Another study confirmed that inhaled insulin is safe and effective for controlling blood sugar. Overall, these findings suggest that TI could serve as a good alternative to traditional insulin injections.13567
Who Is on the Research Team?
Michael R Rickels, MD, MA
Principal Investigator
University of Pennsylvania
Michael Ridell, PhD
Principal Investigator
York University
Are You a Good Fit for This Trial?
This trial is for adults aged 18-60 with Type 1 Diabetes using a Tandem t:slim X2 insulin pump and Control-IQ technology. Participants should be physically active, have been on their current insulin regimen for at least 90 days, and not have any conditions or take medications that could pose safety risks.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants complete three structured exercise sessions with different insulin administration methods
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Technosphere Insulin
Trial Overview
The study compares the effects of inhaled Technosphere Insulin (TI) versus rapid-acting analog (RAA) insulin from a pump when exercising after eating. It aims to determine which method better prevents exercise-induced hypoglycemia in people with Type 1 Diabetes.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
TI for meal bolus with Control IQ + sleep activity pump setting
RAA for meal bolus with with Control IQ + sleep activity pump setting
RAA for meal bolus with Control IQ pump setting with transition to Control IQ + exercise activity pump setting one hour before start of exercise
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jaeb Center for Health Research
Lead Sponsor
Mannkind Corporation
Industry Sponsor
Michael E. Castagna
Mannkind Corporation
Chief Executive Officer since 2017
PharmD from Massachusetts College of Pharmacy & Sciences, MBA from The Wharton School of Business at the University of Pennsylvania
Burkhard Blank
Mannkind Corporation
Chief Medical Officer since 2021
MD
Tandem Diabetes Care, Inc.
Industry Sponsor
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborator
Citations
Safety and Efficacy of Inhaled Technosphere® Insulin in the ...
This study investigated whether a higher modified dose conversion of TI results in greater improvement in postprandial glycemic management ...
Technosphere insulin in the treatment of Type 1 diabetes ...
There was no significant difference in the reduction of HbA1c levels. ... TI group had a significant greater weight reduction or less weight gain.
3.
diabetesjournals.org
diabetesjournals.org/care/article/48/3/353/157574/A-Randomized-Trial-Comparing-Inhaled-Insulin-PlusA Randomized Trial Comparing Inhaled Insulin Plus Basal ...
Affinity 1 Study Group . Inhaled Technosphere insulin compared with injected prandial insulin in type 1 diabetes: a randomized 24-week trial.
4.
healio.com
healio.com/news/endocrinology/20250622/inhaled-insulin-safe-effective-for-children-with-diabetesInhaled insulin safe, effective for children with diabetes
The primary outcome was HbA1c at 26 weeks. The technosphere insulin group had an increase in HbA1c from 8.22% at baseline to 8.41% at 26 weeks.
Results of a 24-Week Trial of Technosphere Insulin Versus ...
Both TI and IA resulted in significant and clinically meaningful HbA1C reductions. TI also resulted in significant and clinically meaningful weight reductions.
Efficacy, safety, and patient acceptability of Technosphere ...
Long-term outcomes and safety with Technosphere insulin should be further investigated. Until further data for safety become available, Technosphere inhaled ...
Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving ...
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.