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Compares treatment options for Diabetes, Gestational
Official title Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes
ClinicalTrials.gov ID: NCT06535789
What this study is testing
What is Inhaled Technosphere Insulin?
Inhaled Technosphere Insulin is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for diabetes, gestational.
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
- Pregnant women aged 18-40 with gestational diabetes (GDM) will take part in this study. We want to see how two different insulin treatments affect their blood sugar after they eat.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- Ability to provide informed consent for study participation
- Age ≥18 years and \<41 years old
- Singleton pregnancy at 24-34 weeks gestation
- Diagnosis of GDM via standard 1-step or 2-step criteria
- Treated with an insulin regimen that includes a RAA bolus of any type for breakfast, with a dose \<20 units
You likely can't join if
- Type 1 diabetes or type 2 diabetes
- 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...
- Current use of any non-insulin glucose lowering medication
- Using TI (Afrezza), regular insulin, or ≥20 RAA units at breakfast (NPH is permissible)
- Peak expiratory flow \<80% predicted as measured by peak flow meter
- Recent history of asthma (defined as using any medications to treat asthma within the last year), chronic obstructive pulmonary disease (COPD), or...
See the full eligibility criteria
- Ability to provide informed consent for study participation
- Age ≥18 years and \<41 years old
- Singleton pregnancy at 24-34 weeks gestation
- Diagnosis of GDM via standard 1-step or 2-step criteria
- Treated with an insulin regimen that includes a RAA bolus of any type for breakfast, with a dose \<20 units
- Pre-pregnancy or first trimester body mass index (BMI) 25-45
- Investigator believes that the protocol can be safely conducted by the participant
- Able to read and speak English
- Type 1 diabetes or type 2 diabetes
- 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)
- Current use of any non-insulin glucose lowering medication
- Using TI (Afrezza), regular insulin, or ≥20 RAA units at breakfast (NPH is permissible)
- Peak expiratory flow \<80% predicted as measured by peak flow meter
- 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...
- Smoking (includes cigarettes, cigars, pipes, and/or vaping devices) within 90 days prior to screening
- History or current diagnosis of lung cancer
- Current or anticipated use of oral, inhaled or injectable glucocorticoids during the time period of the trial (topical glucocorticoid use is acceptable)
- Renal or hepatic impairment that in the investigator's judgment poses a safety risk for the study participant
- Recurrent Level 2 (blood glucose \<54 mg/dL) or Level 3 severe hypoglycemia events
- Current use of non-cardio-selective beta blockers
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Santa Barbara, California, United States
- Aurora, Colorado, United States
- New York, New York, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, 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 - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Barbara, California, United States; Aurora, Colorado, United States; New York, New York, United States; Portland, Oregon, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.