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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT02671968
Eligibility Criteria:
Inclusion Criteria:
* Patients with type 1 diabetes for at least 12 months on multiple daily injections (MDI). MDI is defined as prandial insulin injections at each major meal (excludes pre-mixed insulin) with doses determined by SMBG and carbohydrate counting, and basal insulin injection(s)
* Age ≥ 18 years
* HbA1c ≤ 9.0 % performed within 4 months before begin of the study
* High risk for severe hypoglycemia (defined as a score of 4 or higher on the Hypoglycemia unawareness scale (HUS) or a history of at least one severe hypoglycemic event in the last 12 months (required third part assistance, not able to treat themselves))
* Willing to not use paracetamol or drugs containing it
* Signed and dated Informed Consent Form
Exclusion Criteria:
* Use of personal real-time-CGM 3 months prior to study entry and during the study (except study devices)
* Use of a flash-glucose monitoring system 3 months prior to study and during the study
* Alcoholism or drug abuse
* Unable to comply with the protocol at the investigators discretion, such as known psychiatric diagnosis, cognitive / physical decline
* Pregnancy or lactation period
* Severe known allergies, e.g. against plaster
* Mental incapacity or language barriers precluding adequate compliance with the study procedures
* Limited or no legal capacity or legal guardianship
* Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor or the clinical research center or their families)
* Participation in another study at the same time with a non-approved drug or a non-CE-labelled medical device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02671968
Study Brief:
Protocol Section:
NCT02671968