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 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT03643692
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥18years of age
* Diagnosis of T1DM for \> 1 year
* Structured education completed in last 3 years and capable of CHO counting
* CBG measured at least twice daily for CGM calibration
* Capacity to follow the protocol and sign the informed consent
* Access to a personal computer/laptop
Exclusion Criteria:
* Severe episode of hypoglycaemia (requiring 3rd party assistance) in last 6 months
* Diabetic ketoacidosis in the last 6 months prior to enrolment
* Impaired awareness of hypoglycaemia (based on Gold score)
* Pregnant or planning pregnancy over time of study procedures
* Breastfeeding
* Enrolled in other clinical trials
* Active malignancy or being investigated for malignancy
* Suspected or diagnosed endocrinopathy like adrenal insufficiency, unstable thyroidopathy, endocrine tumour
* Gastroparesis
* Autonomic neuropathy
* Macrovascular complications (acute coronary syndrome, transient ischaemic attack, cerebrovascular event within the last 12 months prior to enrolment in the study)
* Visual impairment including unstable proliferative retinopathy
* Reduced manual dexterity
* Inpatient psychiatric treatment
* Abnormal renal function test results (calculated GFR \<40 mL/min/1.73m2)
* Liver cirrhosis
* Not tributary to optimization to insulin therapy
* Abuse of alcohol or recreational drugs
* Oral steroids
* Regular use of the paracetamol, beta-blockers or any other medication that the investigator believes is a contraindication to the participant's participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03643692
Study Brief:
Protocol Section:
NCT03643692