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

1 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

80

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Ukraina
      • Kyiv, Ukraina, 01601
        • Rekrutacyjny
        • Bogomolets National Medical University
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Nazarii Kobyliak, Professor
        • Pod-śledczy:
          • Eva Ilkiv, PhD Student
      • Kyiv, Ukraina, 01601
        • Rekrutacyjny
        • University Hospital of Bogomolets National Medical University
        • Kontakt:
        • Kontakt:
      • Kyiv, Ukraina, 01601
        • Rejestracja na zaproszenie
        • Bogomoletz Institute of Physiology

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Urządzenie: On-Call Extra Glucometer
Capillary glucose monitoring using fingerstick glucometer as per standard care.
Eksperymentalny: 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.
Urządzenie: CGM Sibionics
A registered medical device for real-time monitoring of glucose levels in interstitial fluid.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Changes in HbA1c level
Ramy czasowe: at 3 month (end of follow-up period)
HbA1c in %
at 3 month (end of follow-up period)
Changes in Fructosamine level
Ramy czasowe: at 1 month (end of intervention period)
Fructosamine in μmol/L
at 1 month (end of intervention period)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
body mass index (BMI)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: at 3 month (follow-up period) compared to baseline
TC in mmol/l
at 3 month (follow-up period) compared to baseline
Tryglicerides (TG)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Nazarii Kobyliak

Współpracownicy

COR-Medical LLC
Iridium LLC

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 lipca 2026

Zakończenie podstawowe (Szacowany)

31 marca 2027

Ukończenie studiów (Szacowany)

31 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

1 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 lipca 2026

Pierwszy wysłany (Rzeczywisty)

8 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

8 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • DI-GLANCE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Insulinooporność

Badania kliniczne na CGM Sibionics

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