Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes

Launched by JAEB CENTER FOR HEALTH RESEARCH · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to manage blood sugar after meals in pregnant women who have gestational diabetes (GDM). The trial will involve women aged 18 to 49 who are currently between 24 and 34 weeks pregnant. Participants will take part in two meal sessions at a clinic, where they will randomly receive either a rapid-acting insulin injection (the usual treatment) or a newer inhaled insulin called technosphere insulin. After each meal, researchers will check their blood sugar levels to see how well each treatment works.

To be eligible for the trial, women must be in their first pregnancy, diagnosed with GDM, and currently taking a specific type of insulin for breakfast. They should not have type 1 or type 2 diabetes and must meet certain health criteria, such as having a body mass index (BMI) between 25 and 45. During the study, participants can expect to be closely monitored and will help researchers understand which insulin method may be more effective for controlling blood sugar after meals. It's important to note that the trial is not yet recruiting participants.

Gender

FEMALE

Eligibility 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