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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT04270656
Eligibility Criteria:
Inclusion Criteria:
* Male / female 35/70 years (including ranges) with T2D ≥ 1 year
* Benefiting from the indication of use of the free Freestyle glucose meter
* Treatment with multi-injection insulin therapy comprising a daily injection of basal insulin (Glargine U100, Glargine U300, Degludec) and at least 2 daily injections of an insulin analogue (lispro, aspart or glulisine) +/- metformin, dipeptidyl peptidase-4 (DPP4) and/or sodium-glucose cotransporter type 2 (SGLT2) at a dose stable for at least 3 months.
* For women of childbearing age, oestro-progestative pill, IUD, implant.
* 11% ≥ HbA1c ≥ 6.5%
* Presence of hepatic steatosis according to the ultrasonography
* Absence of chronic alcoholic intoxication
* Absence of chronic viral hepatitis or other chronic liver diseases (eg hemochromatosis ...)
Exclusion Criteria:
* Type 1 diabetes
* Contraindication to pump treatment
* Treatment with anti-diabetics or other than metformin, dipeptidyl peptidase-4 (DPP4) and/or sodium-glucose cotransporter type 2 (SGLT2)
* Treatment with basal inulin of Levemir
* Contraindication to performing MRI
* Chronic alcohol abuse (after alcohol consumption\> 20g / day in men and\> 10g / day in women) according to the medical examination
* Chronic viral hepatitis based on HBV and HCV serology results
* Hemochromatosis according to the martial assessment
* Other toxic or drug hepatitis
* Severe hepatic pathology: hepatic cirrhosis, hepatocellular carcinoma
* Severe renal insufficiency (MDRD \<30 ml / min)
* Severe and progressive cardiovascular pathology
* Treatment (permanent or intermittent) with glucocorticoids
* Treatment known to improve hepatic steatosis (glitazone, vitamin E, orlistat)
* history or bariatric surgery project for the duration of the study
* Drug treatment likely to cause hepatic steatosis (amiodarone, carbamazepine, tamoxifen, valproate, clozapine, anti-retroviral drugs) unless the dose has been stable for ≥ 3 months
* Guardianship, curatorship or safeguard of justice
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
37 Years
Maximum Age:
70 Years
Study:
NCT04270656
Study Brief:
Protocol Section:
NCT04270656