DIabetes GLycemic Assessment in Newly Confirmed Episodes

NCT07690163 | Recruiting

• 1 other identifier: DI-GLANCE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

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

Keywords

obesity; continuous glucose monitoring; insulin resistance; traditional glycemia self-monitoring; type 2 diabetes

Outcome Measures

Primary Outcomes (2)

• Changes in HbA1c level

  HbA1c in percent

  at 3 month (end of follow-up period)

• Changes in Fructosamine level

  Fructosamine in μmol/L

  at 1 month (end of intervention period)

Secondary Outcomes (11)

• Homeostatic Model Assessment of Insulin Resistance (HOMA2-IR)

  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

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

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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Bogomolets National Medical University

Kyiv, 01601, Ukraine

RECRUITING

Bogomoletz Institute of Physiology

Kyiv, 01601, Ukraine

ENROLLING BY INVITATION

University Hospital of Bogomolets National Medical University

Kyiv, 01601, Ukraine

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Overweight; Insulin Resistance

Condition Hierarchy (Ancestors)

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

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: July 1, 2026
• First Posted: July 8, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

UA (3)