PREdiabetes GLycemic Impact and Data Evaluation

NCT07599072 | Recruiting

• 1 other identifier: PRE-GLIDE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pre Diabetic; Obesity & Overweight; Insulin Resistance

Keywords

prediabetes; obesity; continuous glucose monitoring; insulin resistance; traditional glycemia self-monitoring

Outcome Measures

Primary Outcomes (2)

• Changes in HbA1c level

  HbA1c in %

  at 3 month (end of follow-up period)

• Changes in Fructosamine level

  Fructosamine in μmol/L

  at 3 month (end of intervention period)

Secondary Outcomes (11)

• HOMA-2IR

  at 3 month (follow-up period) compared to baseline

• insulin sensitivity (%S)

  at 3 month (follow-up period) compared to baseline

• β-cell function (%B)

  at 3 month (follow-up period) compared to baseline

• body mass index (BMI)

  at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline

• waist circumferences (WC)

  at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline

Study Arms (2)

CGM group

EXPERIMENTAL

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.

Device: CGM Sibionics

traditional fingerstick glucometer

ACTIVE COMPARATOR

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.

Device: On-Call Extra Glucometer

Interventions

CGM Sibionics DEVICE

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

CGM group

On-Call Extra Glucometer DEVICE

Capillary glucose monitoring using fingerstick glucometer as per standard care.

traditional fingerstick glucometer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years and older.
• Presence of prediabetes diagnosed according to criteria of the American Diabetes Association
• Persons who treated with diet and exercise alone or metformin on a stabilized dose for at least 3 months before the study;
• Ability to comply with protocol requirements and maintain a patient diary.
• Signed informed consent.

You may not qualify if:

• Presence of type 1 or type 2 diabetes;
• Decompensated liver or kidney diseases (GFR \< 45 ml/min/1. 73 m²);
• Active cardiovascular diseases within 12 months of Visit 1, such as myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study;
• Endocrine disorders (e.g., Itsenko-Cushing syndrome, acromegaly) that affect glycemia;
• Pregnancy or lactation;
• Mental or cognitive impairments that would interfere with study participation;
• Daily use of any form of steroid medication (oral, inhaled, injected) within the last 3 months;
• Recent use of any CGM within the last 12 months;
• Known allergy to sensor materials;
• Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant;
• Participation in another clinical study within the last 3 months.

Sponsors & Collaborators

• Nazarii Kobyliak: lead
• COR-Medical LLC: collaborator
• Iridium LLC: collaborator

Study Sites (2)

Bogomolets National Medical University

Kyiv, 01601, Ukraine

RECRUITING

University Hospital of Bogomolets National Medical University

Kyiv, 01601, Ukraine

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance; Obesity; Overweight; Insulin Resistance; Prediabetic State

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Nazarii Kobyliak

  Bogomolets National Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazarii Kobyliak, Professor

CONTACT

+380442356005; nazariikobyliak@gmail.com

Ilona Rudneva, Dr

CONTACT

0442356005; ilonarudneva57@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Rector for Research and Innovation

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

UA (2)