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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT01966393
Eligibility Criteria:
Inclusion Criteria:
* Males and females ≥ 18 years of old.
* Clinical diagnosis of type 1 diabetes for at least one year.
* The subject will have been on insulin pump therapy for at least 3 months.
* HbA1c ≤ 12%.
Exclusion Criteria:
* Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
* Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
* History of pheochromocytoma or insulinoma (glucagon could induce an hormonal response of these tumors)
* Beta-blockers at high dose based on investigator's evaluation of dosage interference with glucagon (glucagon can modify effect of beta-blockers, mostly evident at very high doses)
* Chronic indometacin treatment (can prevent glucagon effect on liver thus its ability to raise glucose)
* Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
* Anticholinergic drug (risk of interaction)
* Pregnancy.
* Severe hypoglycemic episode within two weeks of screening.
* Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
* Known or suspected allergy to the trial products or meal contents (gluten free menus will be available).
* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. need for major revision of carbohydrate counting).
* Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
* Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc).
* Treatments that could interfere with glucagon
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01966393
Study Brief:
Protocol Section:
NCT01966393