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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT06115460
Eligibility Criteria:
Inclusion Criteria:
* T1DM patients aged 12-18 years with at least 5 years disease duration defined according to the criteria of International Society for Pediatric and Adolescent Diabetes (ISPAD) .
* Patients on insulin pump therapy using Medtronic advanced hybrid closed system (Medtronic, Northridge, USA) with Guardian™ 3 sensor or Guardian™ 4 sensor and Guardian link transmitter initiated at least 6 months before the study, patients with minimum daily insulin requirement of more than 8 units, willingness and ability to adhere to the study protocol, and access to the internet as well as a computer system that met requirements for uploading the study pump data.
* Active diabetic nephropathy in the form of microalbuminuria (urinary albumin excretion ) 30-299 mg/g creatinine in two of three samples over a 3- to 6-months period despite angiotensin converting enzyme inhibitors).
* Hemoglobin A1c (HbA1c) ≤8.5%.
* Patients on regular visits to clinic.
Exclusion Criteria:
* patients with other diabetic microvascular complications (neuropathy or retinopathy) or with macrovascular complications.
* Patients with history of liver disease or any disorder likely to impair liver functions or elevated liver enzymes.
* Patients with any evidence of renal impairment due to causes other than diabetes.
* Patients with hypertension.
* Hepatitis virus infection (B or C) or any evidence of infection
* Participation in a previous investigational drug study within 3 months preceding screening.
* Hypoglycemic unawareness or recurrent severe hypoglycemic episodes in the last 6 months prior to recruitment.
* Recurrent diabetic ketoacidosis (DKA) (more than 2 episodes in the previous 6 months).
* Taking other oral hypoglycemic medications which could affect blood glucose.
* Patients with known allergy to sitagliptin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT06115460
Study Brief:
Protocol Section:
NCT06115460