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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT04758858
Eligibility Criteria:
Inclusion Criteria:
* Men and women \> 18 years old
* Duration of T1D \> 12 months
* On intensive insulin therapy
* Own a smartphone or tablet to use two mobile applications for nutritional and physical activity tracking: Keenoa and Piezo: Achieve the Guidelines!
Exclusion Criteria:
* Already following a low-CHO diet (\<30% CHO)
* Type 2 diabetes or other form of diabetes
* Known gastroparesis (clinical diagnosis)
* Advanced kidney disease (eGFR \< 50 mL/min)
* Known significant liver disease (e.g. cirrhosis, active hepatitis, liver transplantation)
* Recent (\<6 months) major cardiovascular event (e.g. myocardial infarction, cerebrovascular accident, major revascularization, etc.)
* Pregnancy (ongoing or planned in the next 6 months)
* Breastfeeding (ongoing)
* Recent severe hypoglycemia episodes (BG \<2.8 mmol/L or assistance from a third party) or ketoacidosis (\<6 weeks)
* Claustrophobia or presence of metal devices/implants in the body
* Recent (\<6 weeks) or planned (next 6 months) modification in insulin treatment
* Recent (\<6 weeks) or planned (next 6 months) modification in cardiometabolic drugs for blood pressure and/or lipids. These drugs must remain stable all along the trial
* Off label adjunct therapy with SGLT-2 inhibitors (Forxiga®, Invokana® or Jardiance®)
* Recent (\<6 weeks) or planned (next 6 months) modification of adjunct therapy (Metformin, Glumetza®, Victoza®, Trulicity® and Ozempic®)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04758858
Study Brief:
Protocol Section:
NCT04758858