Evaluation of Continuous Glucose Monitoring Systems for Optimizing Glycemic Control in Patients With Newly Diagnosed Type 2 Diabetes: A Postmarketing Clinical Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Changes in Fructosamine level
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: On-Call Extra Glucometer (Device)
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.
干预措施: CGM Sibionics (Device)
结局指标
主要结局
Changes in Fructosamine level
时间窗: at 1 month (end of intervention period)
Fructosamine in μmol/L
Changes in HbA1c level
时间窗: at 3 month (end of follow-up period)
HbA1c in percent
次要结局
- 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)
- visceral fat content(at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline)
- Total Cholesterol (TC)(at 3 month (follow-up period) compared to baseline)
- Tryglicerides (TG)(at 3 month (follow-up period) compared to baseline)
- LDL-Cholesterol (LDL-C)(at 3 month (follow-up period) compared to baseline])
- Physical activity levels(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)(at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline)
研究者
Nazarii Kobyliak
Vice Rector for Research and Innovation
Bogomolets National Medical University