DIabetes GLycemic Assessment in Newly Confirmed Episodes (DI-GLANCE)

July 1, 2026 updated by: Nazarii Kobyliak

Evaluation of Continuous Glucose Monitoring Systems for Optimizing Glycemic Control in Patients With Newly Diagnosed Type 2 Diabetes: A Postmarketing Clinical Analysis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Newly diagnosed Type 2 Diabetes (T2D) represents a critical therapeutic window where intensive glycemic control can significantly preserve beta-cell function, reduce glycemic variability, and potentially induce diabetes remission. International guidelines emphasize that early, tight glycemic control is strongly associated with a better long-term prognosis and a reduced risk of micro- and macrovascular complications. However, traditional self-monitoring of blood glucose (SMBG) via finger-prick glucometers offers only static "snapshots" of glucose levels, missing critical fluctuations, asymptomatic hypoglycemia, and postprandial spikes. Routine indicators like fasting plasma glucose and glycated hemoglobin (HbA1c) fail to capture the full spectrum of glycemic variability, which is an independent risk factor for cardiovascular disease.

Recently, Continuous Glucose Monitoring (CGM) technology has emerged as a transformative tool, providing real-time, 24-hour glucose profiles. Beyond its clinical utility, CGM serves as a powerful biofeedback mechanism, motivating patients to adopt sustainable lifestyle changes-such as targeted physical activity, dietary adjustments, and improved sleep hygiene. While CGM is widely adopted in established diabetes management, its clinical utility, impact on patient adherence, and quality of life in individuals with newly diagnosed T2DM who are starting or optimizing non-insulin pharmacological therapies remain insufficiently explored.

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 intensive intervention period with the assigned monitoring devices (CGM or SMBG) and pedometers will last for the first 1 month, followed by a 2-month observation phase. The study consists of three outpatient visits:

  • Visit 1 (Baseline);
  • Visit 2 (1 month, end of active intervention);
  • Visit 3 (3 months, end of follow-up period).

During these visits, comprehensive metabolic, anthropometric, and psychological assessments will be conducted, including HbA1c, fructosamine, C-peptide, insulin resistance indices (HOMA2-IR), lipid profile, body mass index (BMI), waist circumference, bioimpedance body composition analysis, objective physical activity monitoring (pedometer data), and the Medical Outcomes Study Short-Form 36 (SF-36) questionnaire to evaluate health-related quality of life.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Kyiv, Ukraine, 01601
        • Recruiting
        • Bogomolets National Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nazarii Kobyliak, Professor
        • Sub-Investigator:
          • Eva Ilkiv, PhD Student
      • Kyiv, Ukraine, 01601
        • Recruiting
        • University Hospital of Bogomolets National Medical University
        • Contact:
        • Contact:
      • Kyiv, Ukraine, 01601
        • Enrolling by invitation
        • Bogomoletz Institute of Physiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age of 18 years and older.
  • Newly diagnosed Type 2 Diabetes Mellitus according to ADA (American Diabetes Association) criteria (Fasting Plasma Glucose ≥ 7.0 mmol/L, or 2-hour Post-Prandial Glucose ≥ 11.1 mmol/L during OGTT, or HbA1c ≥6.5%).
  • Time since the initial diagnosis of T2D must not exceed 3 months ( less 90 days) at the time of screening.
  • HbA1c level between 6.5% and 9.5% (inclusive) at screening.
  • Patients may be lifestyle-controlled or receiving any stable non-insulin anti-diabetic therapy (including Metformin, SGLT2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, or Sulfonylureas) as monotherapy or combination therapy.
  • Ability to provide written informed consent and willingness to adhere to the study protocol and follow-up schedule.

Exclusion Criteria:

  • Diagnosis or suspicion of Type 1 Diabetes, Latent Autoimmune Diabetes in Adults (LADA) (e.g., positive anti-GAD antibodies if tested), or secondary types of diabetes (e.g., pancreatic or drug-induced).
  • Any prior or current use of insulin therapy.
  • Severe microvascular or macrovascular complications (proliferative retinopathy, severe diabetic nephropathy with eGFR < 45 mL/min/1.73m², diabetic foot ulcers, severe peripheral neuropathy).
  • Endocrine disorders (e.g., Itsenko-Cushing syndrome, acromegaly) that affect glycemia.
  • History of myocardial infarction, stroke, unstable angina, coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) within the past 6 months.
  • Active malignancy, decompensated heart failure (NYHA Class III or IV), or chronic infectious diseases.
  • Pregnant or breastfeeding women, or women of childbearing potential not using highly effective contraception.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: On-Call Extra Glucometer
Capillary glucose monitoring using fingerstick glucometer as per standard care.
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.
Device: CGM Sibionics
A registered medical device for real-time monitoring of glucose levels in interstitial fluid.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in HbA1c level
Time Frame: at 3 month (end of follow-up period)
HbA1c in %
at 3 month (end of follow-up period)
Changes in Fructosamine level
Time Frame: at 1 month (end of intervention period)
Fructosamine in μmol/L
at 1 month (end of intervention period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
body mass index (BMI)
Time Frame: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
weight in kg and height in meters will be combined to report BMI in kg/m^2
at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
waist circumferences (WC)
Time Frame: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
WC in cm
at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
Total Cholesterol (TC)
Time Frame: at 3 month (follow-up period) compared to baseline
TC in mmol/l
at 3 month (follow-up period) compared to baseline
Tryglicerides (TG)
Time Frame: at 3 month (follow-up period) compared to baseline
TG in mmol/l
at 3 month (follow-up period) compared to baseline
LDL-Cholesterol (LDL-C)
Time Frame: at 3 month (follow-up period) compared to baseline]
LDL-C in mmol/l
at 3 month (follow-up period) compared to baseline]
Physical activity levels
Time Frame: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
Daily number of steps as measured by a sealed pedometer
at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
Homeostatic Model Assessment of Insulin Resistance (HOMA2-IR)
Time Frame: at 3 month (follow-up period) compared to baseline
HOMA2-IR will be calculated based on fasting plasma glucose and fasting serum insulin levels using the non-linear Homeostasis Model Assessment. The score is continuous, theoretically starting from 0, where higher values indicate greater insulin resistance (a worse clinical outcome).
at 3 month (follow-up period) compared to baseline
insulin sensitivity (%S)
Time Frame: at 3 month (follow-up period) compared to baseline
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism
at 3 month (follow-up period) compared to baseline
β-cell function (%B)
Time Frame: at 3 month (follow-up period) compared to baseline
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism
at 3 month (follow-up period) compared to baseline
Quality of Life Evaluation: Medical Outcomes Study Short-Form 36 (SF-36)
Time Frame: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
Health-related quality of life will be evaluated using the Medical Outcomes Study Short-Form 36 (SF-36) questionnaire. The SF-36 consists of 36 items measuring 8 health domains, which are aggregated into two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). For each domain and summary score, values are transformed to a scale ranging from a minimum of 0 to a maximum of 100. Higher scores represent better health status and a better quality of life outcome.
at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
visceral fat content
Time Frame: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
visceral fat content using electronic scales-analyzers of body composition Huawei (Smart Scale series 3/3 Pro)
at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nazarii Kobyliak

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
COR-Medical LLC
Iridium LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DI-GLANCE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insulin Resistance

Clinical Trials on CGM Sibionics

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings