Comparing inhaled insulin to injections for controlling blood sugar in pregnant women with diabetes
The Safety and Efficacy of Rapid Acting Inhaled Technosphere Insulin (Afrezza) Compared With Subcutaneous Insulin to Achieve Pregnancy-Specific Postprandial Targets Among Patients With Gestational Diabetes
This study tests whether inhaled insulin can help pregnant women with diabetes control their blood sugar better than traditional insulin injections.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Jaeb Center for Health Research Academic / other |
| Locations | 5 sites (Santa Barbara, California and 4 other locations) |
| Trial ID | NCT06535789 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of inhaled insulin versus traditional rapid-acting insulin injections for managing post-meal blood sugar levels in pregnant women diagnosed with gestational diabetes. Participants aged 18-40 will be randomly assigned to use either inhaled technosphere insulin or injected insulin during two meal sessions. Blood sugar levels will be monitored and compared after each meal to determine which method provides better glucose control. The study aims to offer a less invasive alternative to insulin injections, potentially improving the quality of life for expectant mothers.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18-40 who are diagnosed with gestational diabetes and currently using rapid-acting insulin injections.
Not a fit: Patients with type 1 or type 2 diabetes, or those with severe glucose intolerance, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more comfortable and effective method for managing blood sugar levels in pregnant women with gestational diabetes.
How similar studies have performed: While inhaled insulin is a newer approach, previous studies have shown promise in using inhaled insulin for diabetes management, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Ability to provide informed consent for study participation 2. Age ≥18 years and \<41 years old 3. Singleton pregnancy at 24-34 weeks gestation 4. Diagnosis of GDM via standard 1-step or 2-step criteria 5. Treated with an insulin regimen that includes a RAA bolus of any type for breakfast, with a dose \<20 units 6. Pre-pregnancy or first trimester body mass index (BMI) 25-45 7. Investigator believes that the protocol can be safely conducted by the participant 8. Able to read and speak English Exclusion Criteria 1. Type 1 diabetes or type 2 diabetes 2. HbA1c ≥ 6.5%, FBG ≥125 mg/dl or 2-hr glucose ≥200 mg/dL on 75g OGTT, or random plasma glucose ≥200 mg/dL (consistent with pre-existing diabetes and not GDM diagnosis) 3. Current use of any non-insulin glucose lowering medication 4. Using TI (Afrezza), regular insulin, or ≥20 RAA units at breakfast (NPH is permissible) 5. Peak expiratory flow \<80% predicted as measured by peak flow meter 6. Recent history of asthma (defined as using any medications to treat asthma within the last year), chronic obstructive pulmonary disease (COPD), or any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease as judged by the Investigator 7. Smoking (includes cigarettes, cigars, pipes, and/or vaping devices) within 90 days prior to screening 8. History or current diagnosis of lung cancer 9. Current or anticipated use of oral, inhaled or injectable glucocorticoids during the time period of the trial (topical glucocorticoid use is acceptable) 10. Renal or hepatic impairment that in the investigator's judgment poses a safety risk for the study participant 11. Recurrent Level 2 (blood glucose \<54 mg/dL) or Level 3 severe hypoglycemia events 12. Current use of non-cardio-selective beta blockers 13. Being a member of the study team, having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study Investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Where this trial is running
Santa Barbara, California and 4 other locations
- Sansum Diabetes Research Institute — Santa Barbara, California, United States (Recruiting)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Katrina Ruedy, MSPH
- Email: kruedy@jaeb.org
- Phone: 813-975-8690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.