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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT01800734
Eligibility Criteria:
Inclusion Criteria:
* patient must be aged between 18 (inclusive) and 65 years old;
* patient must have been diagnosed with type 1 diabetes(positive islet cell antibodies;
* use of an insulin pump to treat his/her diabetes for at least 1 year;
* actively using a carbohydrate/insulin ratio for insulin bolus adjustments in order to keep blood glucose in a predefined range;
* patient HbA1c is between 6,0% and 9,0% (standardized with DCCT);
* patient must be willing to avoid consumption of acetaminophen containing products during the study involving DexCom (one CGM system which will be employed in this study) use;
* patient must demonstrate proper mental status and cognition for the study;
* patient has signed informed consent from prior to study entry.
Exclusion Criteria:
* diabetic ketoacidosis within the 6 months prior to enrollment;
* severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment;
* pregnancy and breast feeding;
* uncontrolled microvascular (diabetic)complications (other than diabetic non-proliferative retinopathy)such as history of laser coagulation, proliferative diabetic retinopathy, known diabetic nephropathy (other than microalbuminuria with normal creatinine) or neuropathy requiring treatment;
* uncontrolled arterial hypertension (diastolic blood pressure \>90 mmHg and/or systolic blood pressure \>160 mmHg);
* conditions which may increase the risk of hypoglycemia such as uncontrolled coronary artery disease during the previous year (e.g. history of myocardial infarction, acute coronary syndrome, therapeutic coronary intervention, coronary bypass or stenting procedure, stable or unstable angina, episode of chest pain of cardiac etiology with documented EKG changes, or positive stress test or catheterization with coronary blockages \>50%), congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic disease or atrial fibrillation;
* drugs affecting glucose metabolism (oral steroids, thiazide diuretic, beta-blockers,beta-agonist, nicotinic acid, immunosuppressant agents, antiretroviral drugs and antipsychotics);
* impaired hepatic function measured as alanine aminotransferase or aspartate aminotransferase \> three times the upper reference limit;
* impaired renal function measured as creatinine \>1.2 times above the upper limit of normal;
* anticoagulant therapy other than aspirin;
* known current or recent alcohol or drug abuse;
* psychiatric disorders that would interfere with study tasks (e.g. inpatient psychiatric treatment within 6 months prior to enrollment);
* mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01800734
Study Brief:
Protocol Section:
NCT01800734