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

1. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Ukraine
      • Kyiv, Ukraine, 01601
        • Rekrutierung
        • Bogomolets National Medical University
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Nazarii Kobyliak, Professor
        • Unterermittler:
          • Eva Ilkiv, PhD Student
      • Kyiv, Ukraine, 01601
        • Rekrutierung
        • University Hospital of Bogomolets National Medical University
        • Kontakt:
        • Kontakt:
      • Kyiv, Ukraine, 01601
        • Anmeldung auf Einladung
        • Bogomoletz Institute of Physiology

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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.
Gerät: 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.
Gerät: CGM Sibionics
A registered medical device for real-time monitoring of glucose levels in interstitial fluid.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in HbA1c level
Zeitfenster: at 3 month (end of follow-up period)
HbA1c in %
at 3 month (end of follow-up period)
Changes in Fructosamine level
Zeitfenster: at 1 month (end of intervention period)
Fructosamine in μmol/L
at 1 month (end of intervention period)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
body mass index (BMI)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: at 3 month (follow-up period) compared to baseline
TC in mmol/l
at 3 month (follow-up period) compared to baseline
Tryglicerides (TG)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Nazarii Kobyliak

Mitarbeiter

COR-Medical LLC
Iridium LLC

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juli 2026

Primärer Abschluss (Geschätzt)

31. März 2027

Studienabschluss (Geschätzt)

31. März 2027

Studienanmeldedaten

Zuerst eingereicht

1. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Juli 2026

Zuerst gepostet (Tatsächlich)

8. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • DI-GLANCE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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