Is NCT06880835 recruiting in Louisville, KY?

Yes, NCT06880835 is currently recruiting participants at its Louisville, KY location. This diabetes mellitus, type 1 clinical trial is actively enrolling qualified participants.

How do I join the diabetes mellitus, type 1 clinical trial in Louisville?

To join this clinical trial in Louisville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Louisville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Diabetes Mellitus, Type 1 Clinical Trial in Louisville, KY

About This Diabetes Mellitus, Type 1 Study in Louisville

This investigator-initiated study will enroll about 30 adults 18 to 65 years of age with type 1 diabetes (T1D) who are using the Tandem t:slim X2 insulin pump or Tandem Mobi insulin pump with Control-IQ or Control-IQ+ technology ("Control-IQ" which will refer to either Control-IQ or Control-IQ+). The study is being done to find out if inhaled insulin given for a meal is safer and better to use than a bolus of insulin through your pump when you exercise following a meal. Participants are asked to complete three study exercise visits in the clinic.

Sponsor: Jaeb Center for Health Research

Who Can Participate

Inclusion Criteria

Ability to provide informed consent for study participation

Age ≥18 years to 65 years

Clinical diagnosis of T1D (per the Investigator)

Using Tandem t:slim X2 or Tandem Mobi insulin pump with Control-IQ for at least 90 days prior to screening visit

Using insulin aspart or insulin lispro in Tandem insulin pump

Total daily insulin dose 20 to 80 units

Usual RAA insulin bolus for 50 gram carbohydrate lunch meal is ≤12 units

Physically active, with at least 3 moderate or vigorous exercise sessions ≥30 minutes per typical week self-reported by participant

No medical, psychiatric, or other conditions, or medications being taken that in the Investigator's judgement would be a safety concern for participation in the study

No electrocardiogram (ECG) abnormality that in the judgment of the investigator, which will take into consideration the usual exercise performed by the participant and their overall medical condition, increases the risk of exercise

Investigator believes that the participant can safely follow the protocol

Able to read and understand written and spoken English or Spanish

Exclusion Criteria

Use of inhaled insulin within one week prior to screening visit

History of asthma, 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

Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 90 days prior to screening visit and no plans to smoke during the study

History or current diagnosis of lung cancer

Forced expiratory volume in 1 second (FEV1) measurement of \<70% of predicted Global Lung Function Initiative value

Pregnant or lactating, planning to become pregnant during the study, or is of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD, or implant); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal) • A pregnancy test is required for any person of childbearing potential.

An event of severe hypoglycemia, as judged by the Investigator, within the 90 days prior to screening visit

An episode of diabetic ketoacidosis (DKA) as defined in section 5.2 within the 90 days prior to screening visit

Any disease other than diabetes or current use (or anticipated use during the study) of any medication (e.g., beta blocker) that, in the judgment of the Investigator, may substantially impact glucose metabolism

Use of a non-insulin glucose-lowering medication (or weight-reduction medication with glucose-lowering effect) within 4 weeks prior to screening visit

Exposure to any investigational drug in the 90 days prior to the screening visit

Current or anticipated acute uses of oral, inhaled, or injectable glucocorticoids during the time period of the study (topical or intranasal glucocorticoid use is acceptable)

Current use of Hydroxyurea medication

Current or anticipated use of a low carbohydrate diet (\<50 grams/day) or low calorie diet (\<800 kcal/day) during the time period of the study

Current treatment for diabetic retinopathy

Known stage 4/5 chronic kidney disease or on dialysis

Having a direct supervisor at place of employment who is 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 study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Louisville?

Yes, this clinical trial (NCT06880835) has an active research site in Louisville, KY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

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

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

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

Diabetes Mellitus, Type 1 Treatment Options in Louisville, KY

If you're searching for diabetes mellitus, type 1 treatment options in Louisville, KY, this clinical trial (NCT06880835) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Louisville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diabetes mellitus, type 1 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all diabetes mellitus, type 1 clinical trials near you to find additional studies recruiting in your area.

Diabetes Mellitus, Type 1 Clinical Trial in Louisville, KY

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