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Type 2 Diabetes (T2DM)DI-GLANCENCT07690163

DIabetes GLycemic Assessment in Newly Confirmed Episodes

A study testing CGM Sibionics and On-Call Extra Glucometer in people with Type 2 Diabetes (T2DM) and Obesity Type 2 Diabetes Mellitus, run by Nazarii Kobyliak at 3 sites in Ukraine.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CGM Sibionics and On-Call Extra Glucometer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
3 sitesUkraine
Study dates
15 Jul 2026to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ukraine3 sites, 3 recruiting
  • Bogomolets National Medical University

    Kyiv, 01601

    Nazarii Kobyliak, Professor, 0442356005, nazariikobyliak@gmail.com

    Ilona Rudneva, PhD Student, 0442356005, ilonarudneva57@gmail.com

    Recruiting
  • Bogomoletz Institute of Physiology

    Kyiv, 01601

    Enrolling by invitation
  • University Hospital of Bogomolets National Medical University

    Kyiv, 01601

    Ilona Rudneva, PhD student, 0442356005, ilonarudneva57@gmail.com

    Victoriia Yerokhovych, PhD, 0442356005, korinnaviktoriaer@gmail.com

    Recruiting

Other trials in Ukraine

About this study

Official title: 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.

Read the 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.

Being tested
CGM Sibionics, On-Call Extra Glucometer
Keywords
obesity, continuous glucose monitoring, insulin resistance, traditional glycemia self-monitoring, type 2 diabetes
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Overweight, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CGM SibionicsDevice

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

  • On-Call Extra GlucometerDevice

    Capillary glucose monitoring using fingerstick glucometer as per standard care.

Study groups in NCT07690163
Study groupRoleWhat they receive
CGM groupExperimentalarticipants 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.
Receives: Device: CGM Sibionics
traditional fingerstick glucometerActive comparatorParticipants 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.
Receives: Device: On-Call Extra Glucometer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in HbA1c level

    HbA1c in percent

    Measured: at 3 month (end of follow-up period)

  2. Changes in Fructosamine level

    Fructosamine in μmol/L

    Measured: at 1 month (end of intervention period)

Secondary outcomes (11)
  1. Homeostatic Model Assessment of Insulin Resistance (HOMA2-IR)

    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).

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

  2. insulin sensitivity (%S)

    This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism

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

  3. β-cell function (%B)

    This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism

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

  4. body mass index (BMI)

    weight in kg and height in meters will be combined to report BMI in kg/m^2

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

  5. waist circumferences (WC)

    WC in cm

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

  6. visceral fat content

    visceral fat content using electronic scales-analyzers of body composition Huawei (Smart Scale series 3/3 Pro)

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

  7. Total Cholesterol (TC)

    TC in mmol/l

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

  8. Tryglicerides (TG)

    TG in mmol/l

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

  9. LDL-Cholesterol (LDL-C)

    LDL-C in mmol/l

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

  10. Physical activity levels

    Daily number of steps as measured by a sealed pedometer

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

  11. Quality of Life Evaluation: Medical Outcomes Study Short-Form 36 (SF-36)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2026
  2. Study start15 Jul 2026
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07690163
Sponsor's protocol ID
DI-GLANCE
Acronym
DI-GLANCE
Status last verified
Jul 2026
First submitted
1 Jul 2026
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CGM Sibionics and On-Call Extra Glucometer in people with Type 2 Diabetes (T2DM) and Obesity Type 2 Diabetes Mellitus, run by Nazarii Kobyliak at 3 sites in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in HbA1c level (time frame: at 3 month (end of follow-up period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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