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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT06652867
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for diabetes subjects with hypoglycemia
* Diagnosed of type 2 diabetes or type 1 based on the WHO guidelines Patient's age from 21-75 years old
* Able to say when the hypo had occurred (free style libre in the outpatient setting, or documented blood glucose less than \< 4 mmol/l (\<70 mg/dl) as an inpatient
Inclusion criteria for diabetes subjects without hypoglycemia:
* Diagnosed of type 2 diabetes or type 1 based on the WHO guidelines
* Patient's age from 21-75 years old
* No hypoglycemia or hypoglycemia unawareness.
Exclusion Criteria:
* eGFR less than 45 ml/min
* Liver enzymes 3 folds greater than upper limit
* Pregnancy
* Patients on steroids or Atypical Antipsychotics or Cyclosporine/Tacrolimus or other medications that may mask hypoglycemia
Exclusion Criteria for diabetes subjects with hypoglycemia
* Unable to determine when hypoglycemic event had taken place
* Hypoglycemic unawareness
* Severe hypoglycemic event in the last 3 months
Exclusion criteria for diabetes subjects without hypoglycemia
* Hypoglycemic event in the preceding week
* Hypoglycemic unawareness
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06652867
Study Brief:
Protocol Section:
NCT06652867