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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT01686620
Eligibility Criteria:
Inclusion Criteria:
* Established clinical diagnosis of type 1 diabetes, consistent with ADA classification criteria (Diabetes Care 35: S64-S71, 2012), for more than 1 year.
* Age: 18 years old, or older.
* Body Mass Index: between 18 and 35 kg/m2, inclusive.
* Willing to use insulin glargine as the only basal insulin throughout the duration of the trial.
* Willingness not to use insulin pump treatment and only use the study glucose meter and CGM devices during the duration of the trial.
Exclusion Criteria:
* History of known hypersensitivity to any of the components in the study medication
* Treatment with pramlintide or GLP-1 analogs within 30 days of screening or anticipated use of these medications during the course of the study.
* Treatment with oral or intravenous corticosteroids in the last 3 months prior to screening. Standard doses of inhalational corticosteroid used as part of a long term treatment regimen are allowed.
* Consistent recent hypoglycemic unawareness within the last six months
* History of more than two severe hypoglycemic events within six months prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01686620
Study Brief:
Protocol Section:
NCT01686620