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 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT03748433
Eligibility Criteria:
PRE-REGISTRATION EVALUATIONS
* Episode of severe hypoglycaemia
* Age \>18 years
* Diagnosis of type 1 diabetes
INCLUSION CRITERIA
* Adults over 18 years of age
* Severe hypoglycaemia requiring ambulance call-out or emergency department attendance within 2 weeks
* Type 1 diabetes confirmed on the basis of clinical features
* Type 1 diabetes for greater than 3 years
EXCLUSION CRITERIA
* Use of CGM within the last 6 months (except short periods of diagnostic blinded use under clinic supervision). Prior use of Abbott FreeStyle Libre Device is permitted.
* Use of pre-mixed insulin
* No access to smartphone or computer
* Pregnant or planning pregnancy
* Breastfeeding
* 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
WITHDRAWAL CRITERIA
Participants will be withdrawn if their ability to give informed consent is impaired. Participants will also be withdrawn, at the chief investigators discretion, if glucose control is negatively impacted by the use of either intervention.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03748433
Study Brief:
Protocol Section:
NCT03748433