Type 1 Diabetes Mellitus study: Technosphere Insulin vs Basal insulin
Official title INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes
ClinicalTrials.gov ID: NCT07224321
What this study is testing
What is Technosphere Insulin?
This is an investigational inhaled insulin medicine being studied as a potential treatment for Type 1 Diabetes in children and teens. It is designed to be inhaled into the lungs so the insulin can enter the bloodstream to help control blood sugar levels.
Also referred to as Afrezza.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if a new inhaled insulin is safe and effective for young people with Type 1 diabetes. It also looks at how satisfied patients and their parents are with the treatment.
- Who it's for
- The study is looking for children and teens aged 6 to under 18 who have just been diagnosed with Type 1 diabetes.
- What's involved
- Participants will take inhaled insulin along with regular injected insulin. They will visit the clinic for check-ups and tests to monitor their health.
- Time commitment
- The main study lasts 13 weeks, with an optional extra 26 weeks for those who continue the treatment.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 26 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- Age 6 to \<18 years of age
- Clinical diagnosis of stage 3 T1D, per the investigator. Stage 3 is defined as hyperglycemia, meeting ADA glycemic and clinical diagnostic criteria
- Able to start the Afrezza-BI regimen within 21 days following T1D diagnosis (day 1 is based on the first insulin dose)
- Forced Expiratory Volume in One Second (FEV1) \>80.0% of predicted Global Lung Function Initiative (GLI) value
- Investigator believes that participant can be expected to follow the study protocol
You likely can't join if
- Prior insulin treatment for stage 2 T1D
- In the judgment of the investigator, history of chronic lung disease, such as asthma, or chronic obstructive pulmonary disease, lung cancer, or any...
- Allergy or known hypersensitivity to human regular insulin
- Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 3 months prior to screening and/or positive cotinine test for...
- Positive urine pregnancy test for female people of childbearing potential
See the full eligibility criteria
- Age 6 to \<18 years of age
- Clinical diagnosis of stage 3 T1D, per the investigator. Stage 3 is defined as hyperglycemia, meeting ADA glycemic and clinical diagnostic criteria
- Able to start the Afrezza-BI regimen within 21 days following T1D diagnosis (day 1 is based on the first insulin dose)
- Forced Expiratory Volume in One Second (FEV1) \>80.0% of predicted Global Lung Function Initiative (GLI) value
- Investigator believes that participant can be expected to follow the study protocol
- No medical, psychiatric, psychosocial conditions, or medications being taken that in the investigator's judgment would be a safety concern for participation in the study
- Prior insulin treatment for stage 2 T1D
- In the judgment of the investigator, history of chronic lung disease, such as asthma, or chronic obstructive pulmonary disease, lung cancer, or any other clinically important pulmonary disease (e.g., cystic fibrosis...
- Allergy or known hypersensitivity to human regular insulin
- Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 3 months prior to screening and/or positive cotinine test for smoking
- Positive urine pregnancy test for female people of childbearing potential
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Gainsville, Florida, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Oklahoma City, Oklahoma, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 26 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Gainsville, Florida, United States; Indianapolis, Indiana, United States and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.