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 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT04764968
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* T1D ≥ 2 years
* Use of insulin pump therapy (without sensor-augmented insulin suspension/adjustment functionality) ≥ 6 months
* Use of CGM (real-time or intermittently scanned) ≥ 3 months and ≥ 70% during the previous 14 days
* HbA1c ≤ 70 mmol/l (8.5%)
* Performs aerobic exercise on a regular basis (≥ 2 times per week; self-reported) and desires to exercise per American Diabetes Association guidelines (150 minutes per week) during the study.
* Use of carbohydrate counting and bolus calculator (self-reported)
* Sensor glucose level \< 3.9 mmol/l on ≥ 4/14 previous days assessed by CGM data
Exclusion Criteria:
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start
* Known or suspected allergies to glucagon or related products
* History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients
* Patients with pheochromocytoma or insulinoma
* Hypoglycemia unawareness
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
* Inability to understand the individual information and to give informed consent
* Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject
* Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04764968
Study Brief:
Protocol Section:
NCT04764968