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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT01557634
Eligibility Criteria:
Inclusion Criteria:
* The subject is between 2 and 6 years of age (inclusive)
* The subject has had type 1 diabetes, as defined by WHO criteria for at least 6 months
* The subject will be an insulin pump user and carers will have a good knowledge of insulin dose adjustment
* HbA1c below 12 % (108mmol/mol)
Exclusion Criteria:
* Non-type 1 diabetes mellitus including those secondary to chronic disease
* Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results
* Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids
* Known or suspected allergy against insulin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
6 Years
Study:
NCT01557634
Study Brief:
Protocol Section:
NCT01557634