Afrezza plus basal insulin for newly diagnosed Type 1 diabetes in youth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 2, single-arm, multicenter study, participants aged 10 to <18 with newly diagnosed stage 3 type 1 diabetes will start inhaled rapid-acting technosphere insulin (Afrezza) together with injected basal insulin within 21 days of diagnosis. Participants will be followed for a 13-week main phase, with an optional extension for up to 26 weeks for those who continue Afrezza plus basal insulin. The trial will collect safety data (including regular FEV1 lung function checks), measures of glycemic control, and questionnaires on participant and parent/guardian satisfaction. Enrollment excludes children with chronic pulmonary disease, prior insulin treatment for stage 2 disease, or reduced lung function (FEV1 ≤80% predicted).

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* 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

Where it's running

• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Barbara Davis Center for Diabetes Young Adult Clinic
  Aurora, Colorado, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• University of Florida
  Gainsville, Florida, United States Recruiting
• Indiana University
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Study coordinator: Jennifer Pleitez
• Email: jpleitez@mannkindcorp.com
• Phone: 818-661-5032

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VV-14300: a gene therapy approach for adults with type 1 diabetes not well controlled on an automated insulin system

  This trial tests VV-14300 in adults with type 1 diabetes who aren’t reaching their blood sugar goals despite using an automated insulin delivery system.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Toronto and 1 other locations · NCT07831798

• New gene therapies VV-14299 and VV-14300 for adults with Type 1 Diabetes failing automated insulin delivery

  This study tests VV-14299 and VV-14300, or VV-14300 alone, in adults with long-standing Type 1 Diabetes whose blood sugar remains poorly controlled despite using an automated insulin delivery system.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Melbourne · NCT07829302

• Oral verapamil in newly diagnosed children and teens with type 1 diabetes

  This study tests whether taking verapamil by mouth can help preserve pancreatic beta cells and reduce insulin needs in kids and teens with recently diagnosed type 1 diabetes.

  Recruiting Phase 2/3 Ain Shams University · Cairo · NCT07804849

• Preventing device-related skin rashes in kids with type 1 diabetes using hydrocolloid vs silicone patches

  This study tests whether silicone-based or hydrocolloid patches help prevent recurring skin irritation from insulin pumps or CGMs in children and teens with type 1 diabetes.

  Recruiting Steno Diabetes Center Copenhagen · Copenhagen · NCT07767461

• AI-assisted remote insulin pump optimization for people with type 1 diabetes

  This study tests an AI-powered tool that suggests insulin pump settings for people with type 1 diabetes, with doctor-approved recommendations delivered to a mobile app.

  Recruiting The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT07732777

• Near-sensor insulin delivery with CGM in people with type 1 diabetes

  A small early-feasibility study tests a dual-port insulin patch pump that includes a CGM sensor to see if delivering insulin near the sensor affects glucose readings and whether an automated control algorithm can manage glucose.

  Recruiting Early Phase 1 ClinSurge Research · Toronto, Ontario · NCT07655076

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.