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:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT03581968
Eligibility Criteria:
Inclusion Criteria:
1. Males and females between 8 and 21 years old.
2. Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
3. The participant will have been on insulin pump therapy for at least 3 months.
4. HbA1c ≤ 11%.
Exclusion Criteria:
1. Participants who cannot or are unwilling to use NovoRapid (Aspart) insulin or Humalog (Lispro) insulin for the duration of the study.
2. Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
3. Failure to comply with the study protocol or with team's recommendations (e.g. not willing to use trial pump, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
21 Years
Study:
NCT03581968
Study Brief:
Protocol Section:
NCT03581968