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NCT06535789RECRUITINGIRB Ready

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

(INHALE-GDM)

Sponsored by Jaeb Center for Health Research

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 30 participants interested
3% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Ability to provide informed consent for study participation 2. Age โ‰ฅ18 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

Type 1 diabetes or type 2 diabetes 2. HbA1c โ‰ฅ 6.5%, FBG โ‰ฅ125 mg/dl or 2-hr glucose โ‰ฅ200 mg/dL on 75g OGTT, or random plasma glucose โ‰ฅ200 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 โ‰ฅ20 RAA units at breakfast (NPH is permissible) 5. Peak expiratory flow \<80% predicted as measured by peak flow meter 6. Recent history of asthm

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

30 participants

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Age Range

18 Years - 40 Years

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Gender

FEMALE

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Sponsor

Jaeb Center for Health Research

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Santa Barbara

California

Location available
View Santa Barbara location page
RECRUITING

Aurora

Colorado

Location available
View Aurora location page
RECRUITING

New York

New York

Location available
View New York location page
RECRUITING

Portland

Oregon

Location available
View Portland location page
RECRUITING

Philadelphia

Pennsylvania

Location available
View Philadelphia location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Gestational Diabetes Treatment in Santa Barbara?

Join others in California exploring innovative treatment options through clinical research

Gestational Diabetes Treatment Options in Santa Barbara, California

If you're searching for Gestational Diabetes treatment in Santa Barbara, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Santa Barbara, Aurora, New York and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Gestational Diabetes. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 30 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Gestational Diabetes?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Gestational Diabetes

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Gestational Diabetes Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06535789. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.