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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT01519102
Eligibility Criteria:
Inclusion Criteria:
* Males and females ≥ 18 and ≤ 65 years of old.
* Clinical diagnosis of type 1 diabetes for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment and medical history (e.g. history of acido-ketosis, etc.); C peptide level and antibody determinations are not needed.
* The subject will have been on insulin pump therapy for at least 3 months.
* Last (less than 3 months) HbA1c ≤ 12%.
Exclusion Criteria:
* Clinically significant nephropathy, neuropathy (especially clinically significant gastroparesis) or retinopathy as judged by the investigator.
* Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
* Pregnancy.
* Severe hypoglycemic episode within two weeks of screening.
• Medication likely to affect with the interpretation of the results: Prandase, Victoza, Byetta and Symlin
* Known or suspected allergy to the trial products or meal contents.
* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
* Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
* Unreliable carbohydrate counting
* Problems with venous access
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01519102
Study Brief:
Protocol Section:
NCT01519102