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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT01621308
Eligibility Criteria:
Case inclusion criteria
* T1DM
* If subjects are on CIPII, they must be included in (8) or
* If subjects are on CIPII, and didn't participate in (8), they must been on CIPII at start of the previous study (8)
* If subjects are on CIPII, they must been on CIPII for the past 4 years without interruptions (\>30 days)
* Proper knowledge of the Dutch language.
Case exclusion criteria
* Impaired renal function (plasma creatinine ≥150 µmol/L or glomerular filtration rate as estimated by the Cockcroft-Gault formula ≤50ml/min)
* Cardiac problems (unstable angina or myocardial infarction within the previous 12 months or New York Heart Association class III or IV congestive heart failure
* Mentally handicapped
* Current or past psychiatric treatment for schizophrenia
* Cognitive or bipolar disorder
* Current use or oral corticosteroids or suffering from a condition which necessitated oral or systemic corticosteroids use more than once in the previous 12 months
* Substance abuse, other than nicotine
* Current gravidity or plans to become pregnant during the trial
* Plans to engage in activities that require going \>25 feet below sea level
* Any condition that the investigator and/or coordinating investigator feels would interfere with trial participation or evaluation of results.
4.4 Control inclusion criteria
* T1DM
* SC insulin as mode of insulin administration
* If subjects are on SC insulin, they must been on SC insulin for the past 4 years without interruption (\>30 days)
* HbA1c at time of matching must be ≥7.0% (53mmol/mol)
* Proper knowledge of the Dutch language.
Control exclusion criteria
* Impaired renal function (plasma creatinine ≥150 µmol/L or glomerular filtration rate as estimated by the Cockcroft-Gault formula ≤50ml/min)
* Cardiac problems (unstable angina or myocardial infarction within the previous 12 months or New York Heart Association class III or IV congestive heart failure
* Mentally handicapped
* Current or past psychiatric treatment for schizophrenia
* Cognitive or bipolar disorder
* Current use or oral corticosteroids or suffering from a condition which necessitated oral or systemic corticosteroids use more than once in the previous 12 months
* Substance abuse, other than nicotine
* Current gravidity or plans to become pregnant during the trial
* Plans to engage in activities that require going \>25 feet below sea level
* Any condition that the investigator and/or coordinating investigator feels would interfere with trial participation or evaluation of results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01621308
Study Brief:
Protocol Section:
NCT01621308