RecruitingNot ApplicableNCT07690163

DIabetes GLycemic Assessment in Newly Confirmed Episodes

Evaluation of Continuous Glucose Monitoring Systems for Optimizing Glycemic Control in Patients With Newly Diagnosed Type 2 Diabetes: A Postmarketing Clinical Analysis


Sponsor

Nazarii Kobyliak

Enrollment

80 participants

Start Date

Jul 15, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called CGM Sibionics and a medical device called On-Call Extra Glucometer for people with insulin resistance, obesity type 2 diabetes mellitus, and other related conditions. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECGM Sibionics

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

DEVICEOn-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

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NCT07690163


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