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DIabetes GLycemic Assessment in Newly Confirmed Episodes

NCT07690163 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-07-14

No results posted yet for this study

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.

Conditions

  • Type 2 Diabetes (T2DM)
  • Obesity Type 2 Diabetes Mellitus
  • Obesity & Overweight
  • Insulin Resistance

Interventions

DEVICE

On-Call Extra Glucometer

Capillary glucose monitoring using fingerstick glucometer as per standard care.

DEVICE

CGM Sibionics

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

Sponsors & Collaborators

  • COR-Medical LLC

    collaborator UNKNOWN

  • Iridium LLC

    collaborator UNKNOWN

  • Nazarii Kobyliak

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Ukraine

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07690163 on ClinicalTrials.gov