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 @ 12:57 PM
Ignite Modification Date:
2025-12-24 @ 12:57 PM
NCT ID:
NCT05508061
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with diabetes mellitus type 1;
* Treated with the Inreda AP system for a minimum of 1 month;
* Age between 18 and 75 years;
* Willing and able to sign informed consent.
Since subjects are treated with the Inreda AP, the following inclusion criteria will be met:
* Treated with sensor augmented pump (SAP) or CSII for a minimum of 6 months;
* HbA1c \< 97 mmol/mol;
* BMI \< 35 kg/m\^2;
* No use of acetaminophen, as this may influence the sensor glucose measurements.
Exclusion Criteria:
* Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire;
* Pregnancy and/or breastfeeding;
* Use of oral antidiabetic agents;
* Insulinoma;
* Hypersensitivity reactions to Lyumjev or any of the excipients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05508061
Study Brief:
Protocol Section:
NCT05508061