The Impact of Continuous Glucose Monitoring on Behavioral Change, Glucose Variability and Weight Loss in Individuals With Prediabetes and Obesity - a Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Change in Glycemic Variability Assessed by Coefficient of Variation from CGM
研究概览
简要总结
This randomized, crossover interventional study evaluates the effects of real-time (open) versus blinded continuous glucose monitoring (CGM) on glycemic variability, lifestyle behaviors, and metabolic outcomes in adults with prediabetes and overweight or obesity (BMI ≥ 27 kg/m²). Thirty participants will undergo both open and blinded CGM phases, separated by a washout period. The study aims to assess whether access to real-time glucose data promotes behavioral change and improves metabolic health compared with blinded CGM use.
详细描述
Prediabetes and obesity are major contributors to the development of type 2 diabetes and its complications. Early intervention focused on glycemic control and lifestyle modification is essential to prevent disease progression. Continuous glucose monitoring (CGM) provides real-time insight into glucose dynamics and may support behavioral change; however, evidence is limited on how access to glucose data influences sustained lifestyle modification and metabolic outcomes in individuals with prediabetes.
The primary objectives are to assess the impact of real-time (open) versus blinded CGM on (1) glycemic variability using sensitive dynamic metrics, and (2) behavioral changes, including dietary habits and physical activity, in adults with prediabetes and overweight or obesity.
Secondary objectives include evaluating the effects of CGM on anthropometric and metabolic parameters, biochemical and physiological markers of metabolic control, participant experience and acceptability of CGM, sustainability of lifestyle changes, and associations between glycemic variability and cardiometabolic risk reduction.
This prospective, randomized, open-label, blinded crossover interventional study will evaluate the effects of CGM on behavior, glycemic variability, and weight loss in adults with prediabetes and obesity (BMI ≥ 27 kg/m²). Thirty participants will be recruited from the Diabetes Outpatient Clinic of the Community Health Center Koper. After screening and a 10-day blinded CGM run-in period, participants will be randomized (1:1) to one of two sequences: (A) open CGM for 12 weeks followed by a 30-day washout and 12 weeks of blinded CGM, or (B) blinded CGM for 12 weeks followed by washout and 12 weeks of open CGM. Participants will attend baseline and follow-up visits for anthropometric, biochemical, and behavioral assessments during each study phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-70 years.
- •BMI ≥ 27 kg/m² (overweight or obese).
- •Prediabetes, confirmed by:
- •Impaired fasting glucose (IFG: 5.6-6.9 mmol/L), and/or Impaired glucose tolerance (IGT: 2-hour OGTT glucose 7.8-11.0 mmol/L).
- •Stable body weight (±3 kg) in the last 3 months.
- •No current use of antidiabetic or weight-loss medications.
- •Willingness and ability to wear a CGM device as instructed.
- •Capacity to provide written informed consent.
- •Recruitment from the Diabetes Outpatient Clinic, Community Health Center Koper (identified and invited from the clinic's database).
排除标准
- •Diagnosis of type 1 or type 2 diabetes mellitus (fasting glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%).
- •Current or recent (within 3 months) use of:
- •Any antidiabetic medication (insulin, metformin, GLP-1RA, SGLT2i, etc.), or anti-obesity pharmacotherapy.
- •Pregnancy, breastfeeding, or planned pregnancy during the study period.
- •Severe chronic disease that could influence glucose metabolism or study participation (e.g., chronic liver disease, renal failure, active malignancy).
- •Endocrine disorders affecting metabolism (e.g., untreated thyroid disease, Cushing's syndrome).
- •Severe psychiatric illness or cognitive impairment limiting adherence or comprehension.
- •Use of medications known to affect glucose metabolism (e.g., corticosteroids, atypical antipsychotics).
- •Implanted electronic medical devices (e.g., pacemaker, defibrillator) that may interfere with CGM function.
- •Known allergy or skin reaction to CGM adhesives or device materials.
- •Participation in another interventional study within the previous 3 months.
研究组 & 干预措施
Open CGM
干预措施: Continuous Glucose Monitoring (CGM) (Device)
Blinded CGM
干预措施: Continuous Glucose Monitoring (CGM) (Device)
结局指标
主要结局
Change in Glycemic Variability Assessed by Coefficient of Variation from CGM
时间窗: End of each 12-week CGM phase
Change in glucose coefficient of variation (CV%), calculated from CGM data, comparing open versus blinded CGM phases. Unit of Measure: Percentage (%)
Postprandial Glucose Excursions Measured by CGM
时间窗: End of each 12-week CGM phase
Mean postprandial glucose excursion (PPGE) following habitual meals, derived from CGM data. Unit of Measure: mmol/L
Change in Mean Daily Energy Intake
时间窗: End of each 12-week CGM phase
Change in mean daily caloric intake assessed using participant-completed food diaries. Unit of Measure: kcal/day
次要结局
- Change in Time in Tight Range (3.9-7.8 mmol/L) Measured by Continuous Glucose Monitoring(End of each 12-week CGM phase)
- Change in Glycemic Variability Assessed by Standard Deviation from CGM(End of each 12-week CGM phase)
- Change in Continuous Overall Net Glycemic Action (CONGA) from CGM(End of each 12-week CGM phase)
- Change in Glycemic Complexity Assessed by Entropy-Based Indices from CGM(End of each 12-week CGM phase)
- Postprandial Incremental Area Under the Curve (iAUC) Derived from CGM(End of each 12-week CGM phase)
- Adherence to Continuous Glucose Monitoring(End of each 12-week CGM phase)
- Change in Fasting Plasma Glucose(Baseline; end of each 12-week CGM phase)
- Change in Body Weight(Baseline; end of each 12-week CGM phase)
- Change in Physical Activity Assessed by IPAQ Short Form(Baseline; end of each 12-week CGM phase)
- Change in Health Status Assessed by EQ-VAS(Baseline; end of each 12-week CGM phase)
- Change in Glycated Hemoglobin (HbA1c)(Baseline; end of each 12-week CGM phase)
研究者
Zala Jenko Praznikar
Assoc. Prof.
University of Primorska