DIabetes GLycemic Assessment in Newly Confirmed Episodes

Sponsor
Nazarii Kobyliak
Study ID
NCT07690163
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CGM Sibionics — DEVICE
    A registered medical device for real-time monitoring of glucose levels in interstitial fluid.
  • On-Call Extra Glucometer — DEVICE
    Capillary glucose monitoring using fingerstick glucometer as per standard care.

Study Details

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.

Key Dates

First listed
Jul 8, 2026
Start date
Jul 15, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: CGM group
    articipants with prediabetes will be provided with a Real-Time Continuous Glucose Monitoring (RT-CGM) device to monitor their blood glucose along with educational materials to better understand and manage their prediabetes and other supporting services. Pre and post intervention surveys and investigation will be implemented. Participants will be utilizing RT-CGM device for 28 days and then followed up for 3-month participation.
  • Active Comparator: traditional fingerstick glucometer
    Participants with prediabetes will be provided with traditional fingerstick glucometer device to self-monitor their blood glucose along with educational materials to better understand and manage their prediabetes and other supporting services. Pre and post intervention surveys and investigation will be implemented. Participants will be utilizing glucometer with at least 2-3 measurements per week for 28 days and then followed up for 3-month participation.

Primary Outcome Measure

Changes in HbA1c level [ Time Frame: at 3 month (end of follow-up period) ]

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