PREdiabetes GLycemic Impact and Data Evaluation

Sponsor
Nazarii Kobyliak
Study ID
NCT07599072
Status
Recruiting
Apply to this trial

Conditions

  • Insulin Resistance
  • Obesity & Overweight
  • Pre Diabetic

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 prospective, randomized controlled trial evaluates whether real-time continuous glucose monitoring (CGM) improves glycemic control and lifestyle adherence in adults with prediabetes compared to conventional self-monitoring methods over a 3-month period. By analyzing metabolic markers and behavioral data, the study aims to determine the effectiveness of 24-hour monitoring as a personalized tool that increases patient adherence to lifestyle changes compared to conventional SMBG methods.

Key Dates

First listed
May 20, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: CGM group
    Participants 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) ]

Central Contacts

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