Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT06408558
Eligibility Criteria:
Inclusion Criteria:
* Able in the opinion of the investigator, and willing to give informed consent obtained before any study-related activities.
* Type 1 diabetes
* Duration of type 1 diabetes greater than 12 months.
* Current treatment insulin pump therapy.
* Male or female aged 18 - 65 years.
* BMI of less than 30 kg/m2.
* HbA1c of less than 9%.
* Able and willing to complete the study.
* No cardiovascular complications
* No significant past respiratory disease
* No chronic (long-term) ENT disease such as vertigo, sinusitis or perforated ear drum
* Fitness to undertake long haul airliner flight as a passenger, without assistance or any form of medical support (e.g. supplementary oxygen)
* Patients who are or who have previously been involved in research are eligible provided they have not received an investigational drug within one month of entry into the study
Exclusion Criteria:
* Outside of stated age range.
* Female who is pregnant, breast feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
* Participation in any clinical trial of an investigational medicinal product within 30 days before screening.
* Inability to understand verbal and / or written explanations given in English.
* Proliferative retinopathy that has required acute treatment within last three months.
* History of severe renal impairment.
* History of unstable or rapidly progressing renal disease.
* History of hepatic insufficiency / and or significant abnormal liver function.
* Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody.
* Congestive heart failure defined as New York Heart Association (NYHA) class III and IV, unstable or acute congestive heart failure. Note: eligible patients with congestive heart failure, especially.
* Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
* Uncontrolled cardiac arrhythmias.
* Uncontrolled hypertension. (BP greater than 160/90).
* Exclude any ENT disease that might interfere with ventilation of the middle ear cavity ('ear clearing') or sinuses
* Any ENT surgery in last 6 months
* Any recent open surgery (last month)
* Claustrophobia
* Inability to communicate over a headset/microphone system
* Intolerance to milk products and those who follow a vegan diet
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06408558
Study Brief:
Protocol Section:
NCT06408558