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RECRUITING
NCT07690163
NA

DIabetes GLycemic Assessment in Newly Confirmed Episodes

Sponsor: Nazarii Kobyliak

View on ClinicalTrials.gov

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

Interventions

DEVICE

CGM Sibionics

A registered medical device for real-time monitoring of glucose levels in interstitial fluid.

DEVICE

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