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:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT01519466
Eligibility Criteria:
Inclusion Criteria:
* Subject with Type 1 diabetes on MDI (3 or more insulin injections per day (U100 insulin)) for at least 1 year and insulin adjusting
* HbA1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive
* Age 18 and over
* In the investigator's opinion, thought technically capable of using masked CGM
* Subject self reporting a minimum of 21 SMBG tests per week prior to study enrolment
* Willing to perform a minimum of 4 SMBG tests per day during study
Exclusion Criteria:
* Subject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety
* Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
* Subject is pregnant / planning to become pregnant within the planned study timeline
* Subject is known to require a dose of more than 50 units of U100 insulin in any one bolus injection
* Subject is currently on an insulin pump
* Subject is currently using the FreeStyle InsuLinx
* Subject is currently using the FreeStyle Freedom Lite
* Subject is currently using CGM
* Subject has an allergy to medical grade adhesives
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01519466
Study Brief:
Protocol Section:
NCT01519466