INHALE-1st: Afrezza® for Youth with Newly-Diagnosed Type 1 Diabetes

This study, called INHALE-1st, is looking at how well Afrezza (an inhaled insulin) works when combined with basal insulin (insulin injected under the skin) for young people aged 10 to 17 who have been recently diagnosed with Type 1 Diabetes. The study wants to see if this combination helps keep blood sugar levels in a healthy range (Time in Range, or TIR). You could join if you are 10 to 17 years old, have newly diagnosed Type 1 Diabetes, and meet certain lung function requirements. The study also wants to understand how satisfied participants and their parents are with this treatment. The study is currently unclear on its recruitment status.

Study design: This is a Phase 2 study with 100 planned participants. It is a single-arm study, meaning all participants will receive the same treatment combination.
What's involved: Participants will be followed for 13 weeks in the main part of the study, with an option to continue for up to 26 weeks.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 13 weeks during the main phase, with an optional extension phase for up to 26 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes

Recruiting

PHASE2Ages 6–17InterventionalTreatment

Mannkind Corporation

~100 participants

Updated 2026-08-13 on ClinicalTrials.gov

What's tested:Technosphere InsulinBasal insulin

At a glance

Recruiting sites

10 of 10 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70%

Measured over 13 weeks

Conditions

Type 1 Diabetes Mellitus

Where it's being run

10 sites across 9 states

California2

Colorado1

Connecticut1

Florida1

Indiana1

Massachusetts1

Oklahoma1

Texas1

Who to contact

Jennifer Pleitez

[email protected]

818-661-5032

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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, bronchopulmonary dysplasia)

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 subjects of childbearing potential

What this trial measures

Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70%13 weeks
Percentage of participants with a CGM-measured TIR 70-180 mg/dL ≥70% during 14 days prior to 13-week visit

Trialytics