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DIabetes GLycemic Assessment in Newly Confirmed Episodes
Sponsor: Nazarii Kobyliak
Summary
This is a prospective, open-label, randomized controlled trial involving 80 adult patients with newly diagnosed T2DM (diagnosed within the last 3 months) recruited at the Bogomolets National Medical University. Participants may be lifestyle-controlled or receiving stable non-insulin anti-diabetic medications. Participants will be randomized in a 1:1 ratio to either the Real-Time Continuous Glucose Monitoring group (CGM group) or the control group (standard Self-Monitoring of Blood Glucose \[SMBG\] using conventional glucometers). The gathered data will help determine whether the real-time visual feedback provided by CGM systems superiorly improves glycemic variability, optimizes metabolic parameters, and enhances patient adherence to lifestyle interventions and pharmacological treatment compared to conventional SMBG methods in the early stages of T2D.
Official title: Evaluation of Continuous Glucose Monitoring Systems for Optimizing Glycemic Control in Patients With Newly Diagnosed Type 2 Diabetes: A Postmarketing Clinical Analysis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-07-15
Completion Date
2027-03-31
Last Updated
2026-07-08
Healthy Volunteers
No
Conditions
Interventions
CGM Sibionics
A registered medical device for real-time monitoring of glucose levels in interstitial fluid.
On-Call Extra Glucometer
Capillary glucose monitoring using fingerstick glucometer as per standard care.
Locations (3)
Bogomolets National Medical University
Kyiv, Ukraine
Bogomoletz Institute of Physiology
Kyiv, Ukraine
University Hospital of Bogomolets National Medical University
Kyiv, Ukraine