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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT01162694
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes patients being treated with insulin for at least 3 months
* HbA1c \> 7%
* \> 25 years of age
* Willingness to test blood glucose levels a minimum of 3 times daily
* Willingness to be trained on using the Continuous Glucose Monitoring System
* Willingness to be randomized
* Trained in self-blood glucose monitoring
* Internet Access on a Windows Personal Computer
* No prior use or training on CGMS in the past 6 months
* No prior use or training on IBGMS in the past 6 months
Exclusion Criteria:
Patients who do not meet the above criteria or are not willing to participate will not be included in the study. Additional exclusion criteria include:
* Patient with medical conditions that may affect their study participation or results will be excluded.
* Patients with the potential to become pregnant
* Patients using medications known to influence control of diabetes (eg steroids systemic or inhaled)
* Liver disease (AST or ALT levels \> 2.5 times the reference level)
* Renal insufficient with a serum creatinine level \> 200 μmol/L
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
70 Years
Study:
NCT01162694
Study Brief:
Protocol Section:
NCT01162694