DIabetes GLycemic Assessment in Newly Confirmed Episodes
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: CGM Sibionics, On-Call Extra Glucometer.
- Кому может быть актуально
- Состояния в реестре: Type 2 Diabetes (T2DM), Obesity Type 2 Diabetes Mellitus, Obesity & Overweight, Insulin Resistance. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Украина
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of Continuous Glucose Monitoring Systems for Optimizing Glycemic Control in Patients With Newly Diagnosed Type 2 Diabetes: A Postmarketing Clinical Analysis
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство CGM Sibionics
A registered medical device for real-time monitoring of glucose levels in interstitial fluid. - Устройство On-Call Extra Glucometer
Capillary glucose monitoring using fingerstick glucometer as per standard care.
Первичные конечные точки
- Changes in HbA1c level [Срок оценки: at 3 month (end of follow-up period)]
- Changes in Fructosamine level [Срок оценки: at 1 month (end of intervention period)]
Вторичные конечные точки (11)
- Homeostatic Model Assessment of Insulin Resistance (HOMA2-IR) [Срок оценки: at 3 month (follow-up period) compared to baseline]
- insulin sensitivity (%S) [Срок оценки: at 3 month (follow-up period) compared to baseline]
- β-cell function (%B) [Срок оценки: at 3 month (follow-up period) compared to baseline]
- body mass index (BMI) [Срок оценки: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline]
- waist circumferences (WC) [Срок оценки: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline]
- visceral fat content [Срок оценки: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline]
- Total Cholesterol (TC) [Срок оценки: at 3 month (follow-up period) compared to baseline]
- Tryglicerides (TG) [Срок оценки: at 3 month (follow-up period) compared to baseline]
- LDL-Cholesterol (LDL-C) [Срок оценки: at 3 month (follow-up period) compared to baseline]]
- Physical activity levels [Срок оценки: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline]
- Quality of Life Evaluation: Medical Outcomes Study Short-Form 36 (SF-36) [Срок оценки: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Украина · 3 центра
- Bogomolets National Medical University — Kyiv
- Bogomoletz Institute of Physiology — Kyiv
- University Hospital of Bogomolets National Medical University — Kyiv
Идентификаторы
NCT: NCT07690163 · DI-GLANCE