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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT05543850
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with type 1 diabetes mellitus
* Twelve to eighteen years old;
* Treated with insulin therapy for at least 6 months;
* Willing and able to sign informed consent or to assent to study participation.
Exclusion Criteria:
* Impaired awareness of hypoglycaemia (score ≥ 4) according to Gold and/or Clarke questionnaire\[6,7\];
* BMI ≥ 35 kg/m2;
* Pregnancy and/or breastfeeding;
* HbA1c \> 97 mmol/mol (11.0%);
* Use of acetaminophen (paracetamol) during the open loop or closed-loop period,as this may influence the sensor glucose measurements;
* Limited ability to see, hear or feel the alarm signals of the closed-loop system;
* Unwillingness to act in response to the alarm signals;
* Living alone during the night during the closed-loop period (the patient may ask someone to stay over temporarily);
* Expected poor internet connectivity regarding 24/7 tele monitoring;
* Any condition that the local investigator feels would interfere with trial participation or evaluation of the results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT05543850
Study Brief:
Protocol Section:
NCT05543850