DIabetes GLycemic Assessment in Newly Confirmed Episodes
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…
Conditions studied
Type 2 Diabetes (T2DM), Obesity Type 2 Diabetes Mellitus, Obesity & Overweight, Insulin Resistance
About this study
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.
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.
Primary outcomes
- Changes in HbA1c level (at 3 month (end of follow-up period))
- Changes in Fructosamine level (at 1 month (end of intervention period))
Eligibility information
Study locations
- Bogomolets National Medical University, Kyiv, 01601 Ukraine
- Bogomoletz Institute of Physiology, Kyiv, 01601 Ukraine
- University Hospital of Bogomolets National Medical University, Kyiv, 01601 Ukraine
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-04.