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 @ 3:05 AM
Ignite Modification Date:
2025-12-25 @ 3:05 AM
NCT ID:
NCT03556033
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes, disease duration \>1 year
* Age \>18 years, \<75 years
* BMI 19-40 kg/m\^2
* Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump)
* Impaired awareness of hypoglycemia as assessed by a score of 3 or more on the modified Dutch translation of the Clarke questionnaire
* Glycated haemoglobin (HbA1c) ≥42 mmol/mol (6%) and ≤75 mmol/mol (9.0%)
* Ability to provide informed consent
Exclusion Criteria:
* Treatment with SGLT-2 inhibitors
* Known intolerance to SGLT-2 inhibitors
* Treatment with loop diuretics or other anti-hypertensive agents
* Treatment with glucose-modifying (other than insulin) or immune-modifying agents (e.g. prednisolon)
* Treatment with pioglitazone
* Use of statins
* A history of cardiovascular disease (e.g. myocardial infarction, stroke, heart failure) or hypotension
* A history of galactose-intolerance, lactase deficiency, glucose-galactose malabsorption
* History of diabetic ketoacidosis requiring medical intervention within 1 month before screening
* Admission to the hospital for hyperglycemia or hypoglycemia within 1 month before screening
* Frequent episodes of severe hypoglycemia within 1 month before screening
* Laser coagulation for proliferative retinopathy (past 6 months)
* Proliferative retinopathy
* Diabetic nephropathy as reflected by an albumin-creatinin ratio ˃ 30 mmol/mg or an estimated glomerular filtration rate (by MDRD) ˂60ml/min/1.73m2
* History of pancreatitis (acute or chronic) or pancreatic cancer
* Use of premixed insulin or of long-acting insulin alone
* Total daily insulin dose requirements \<20 units unless on pump treatment
* Pregnancy or unwillingness to undertake measures for birth control
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03556033
Study Brief:
Protocol Section:
NCT03556033