No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 40
Sex
Female
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Jaeb Center for Health Research · Other
Who this trial is looking for
This trial is looking for pregnant women aged 18-40 who have gestational diabetes. Participants will try two types of insulin to see which one works better for controlling blood sugar after meals.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesType 2 diabetes
You may be able to join if
I am between 18 and 40 years old.
I am pregnant and between 24 and 34 weeks along.
I have been diagnosed with gestational diabetes.
I use a rapid-acting insulin for breakfast.
My body mass index (BMI) is between 25 and 45.
I can read and speak English.
I can give informed consent for the study.
My doctor believes I can participate safely.
You may not be able to join if
I have type 1 or type 2 diabetes.
My blood sugar levels indicate pre-existing diabetes.
I use any non-insulin medications to lower my blood sugar.
I have a recent history of asthma or serious lung disease.
I have smoked in the last 90 days.
I have a history of lung cancer.
I am using glucocorticoids like steroids.
I have significant kidney or liver problems.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. These women usually use a rapid-acting insulin analog (RAA) that's injected to control their blood sugar before and after meals. They will come to the clinic for two meal sessions. For the first meal, we will randomly d…
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. These women usually use a rapid-acting insulin analog (RAA) that's injected to control their blood sugar before and after meals. They will come to the clinic for two meal sessions. For the first meal, we will randomly decide if they will use the usual RAA insulin or a newer inhaled insulin called technosphere insulin (TI). They will use the other type of insulin for their second meal. After each meal, we will compare their blood sugar levels.
Trial Locations
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Status
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 f…
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
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