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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02617160
Eligibility Criteria:
Inclusion Criteria:
* Documented Type 1 Diabetes for at least 1 year prior to study enrollment
* Segment A:Subjects aged ≥ 10 years and up to 25 years Segment B: Subjects aged ≥ 6 years Segment C: Subjects aged ≥ 6 years and up to 30 years
* HbA1c at inclusion ≤ 11%
* Insulin pump therapy for at least 4 months for segment A and C and at least 3 months for segment B
* BMI Standard Deviation Score - below the 97th percentile for age
* Subjects have continuous glucose monitoring data for at least 2-3 weeks before the clinic regular visit (for segment B only)
* Without routine sensor use (for segment C only)
* Subjects willing to follow study instructions
Exclusion Criteria:
* An episode of diabetic keto-acidosis within the month prior to study entry
* Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment
* Concomitant diseases/ treatment that influence metabolic control
* Significant diseases /conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subjects ability to complete the study or compromise patients safety
* Participation in any other interventional study
* Known or suspected allergy to trial products
* Female subject who is pregnant or planning to become pregnant within the planned study duration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
30 Years
Study:
NCT02617160
Study Brief:
Protocol Section:
NCT02617160