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:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT03028220
Eligibility Criteria:
Inclusion Criteria:
* Adults over 18 years of age
* Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide \<200 pmol/L
* Severe hypoglycaemic event in the last 12 months requiring third party assistance OR a Gold Score ≥ 4
* Type 1 diabetes for greater than 3 years
* On an intensified multiple dose insulin injection regimen for \> 6 months (MDI)
* Previous type 1 diabetes structured education (either group or 1:1)
Exclusion Criteria:
* Use of CGM or Libre device within the last 6 months (except short periods of diagnostic blinded use under clinic supervision)
* Use of regular paracetamol
* Pregnant or planning pregnancy
* Breastfeeding
* Enrolled in other clinical trials, except at the discretion of the chief investigator
* Have active malignancy or under investigation for malignancy
* Severe visual impairment
* Reduced manual dexterity
* Unable to participate due to other factors, as assessed by the Chief Investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03028220
Study Brief:
Protocol Section:
NCT03028220