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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT01781533
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 18 to 75 years (both inclusive)
* Informed consent obtained after being advised of the nature of the study
* The subject has Type 1 diabetes (as defined by WHO) for at least 24 months
* The subject's HbA1c \<= 10%
* Body Mass Index (BMI) \<= 35 kg/m2
* The subject is treated with continuous subcutaneous insulin infusion for at least 3 month
Exclusion Criteria:
* Subject is actively enrolled in another clinical trial or took part in a study within 30 days
* Experienced recurrent severe hypoglycaemic unawareness
* Total daily insulin dose \>= 1.4 IU/kg
* Subject is using a medication that significantly impacts glucose metabolism (oral or topical steroids) except if stable for at least the last three months and expected to remain stable for the study duration
* Allergy against insulin Lispro
* A history of drug or alcohol dependence
* Any other significant concomitant disease such as endocrine, cardiac, neurological, malignant, other pancreatic disease or uncontrolled hypertension as judged by the investigator
* Uncontrolled hypertension with resting blood pressure over 140/90 mmHg
* Patient is pregnant, or breast feeding during the period of the study
* Patient donated blood in the last 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01781533
Study Brief:
Protocol Section:
NCT01781533