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| Name | Class |
|---|---|
| Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia | UNKNOWN |
| University Medical Centre Ljubljana | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open CGM | Experimental |
| |
| Blinded CGM | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring (CGM) | Device | Use of a continuous glucose monitoring system to measure interstitial glucose levels. During the open CGM phase, participants have real-time access to glucose data; during the blinded CGM phase, glucose data are masked from participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycemic Variability Assessed by Coefficient of Variation from CGM | Change in glucose coefficient of variation (CV%), calculated from CGM data, comparing open versus blinded CGM phases. Unit of Measure: Percentage (%) | End of each 12-week CGM phase |
| Postprandial Glucose Excursions Measured by CGM | Mean postprandial glucose excursion (PPGE) following habitual meals, derived from CGM data. Unit of Measure: mmol/L | End of each 12-week CGM phase |
| Change in Mean Daily Energy Intake | Change in mean daily caloric intake assessed using participant-completed food diaries. Unit of Measure: kcal/day | End of each 12-week CGM phase |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Time in Tight Range (3.9-7.8 mmol/L) Measured by Continuous Glucose Monitoring | Change in percentage of time glucose values are within the tight range of 3.9-7.8 mmol/L, derived from continuous glucose monitoring (CGM) data, comparing open versus blinded CGM phases. Unit of Measure: Percentage (%) | End of each 12-week CGM phase |
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Inclusion Criteria:
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).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ajda Urbas, medical doctor | Contact | 0038631626966 | ajda.urbas@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ajda Urbas, MD | Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia | Principal Investigator |
| Mojca Jensterle Sever, PhD | University Medical Centre Ljubljana, Department Of endocrinology and diabetes, Medical Faculty, University of Ljubljana |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Primorska, Faculty of Health Sciences | Recruiting | Izola | 6310 | Slovenia |
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|
| Change in Glycemic Variability Assessed by Standard Deviation from CGM |
Change in standard deviation of interstitial glucose values derived from CGM data, comparing open versus blinded CGM phases. Unit of Measure: mmol/L |
| End of each 12-week CGM phase |
| Change in Continuous Overall Net Glycemic Action (CONGA) from CGM | Change in CONGA index calculated from CGM glucose profiles, reflecting short-term glycemic variability, comparing open versus blinded CGM phases. Unit of Measure: mmol/L | End of each 12-week CGM phase |
| Change in Glycemic Complexity Assessed by Entropy-Based Indices from CGM | Change in glucose pattern complexity assessed using entropy-based indices derived from CGM data, comparing open versus blinded CGM phases. Unit of Measure: Unitless index | End of each 12-week CGM phase |
| Postprandial Incremental Area Under the Curve (iAUC) Derived from CGM | Incremental area under the glucose curve (iAUC) following habitual meals, calculated from CGM data. Unit of Measure: mmol/L·min | End of each 12-week CGM phase |
| Adherence to Continuous Glucose Monitoring | Adherence to CGM use, defined as percentage of days with valid CGM data and frequency of data uploads. Unit of Measure: Percentage (%) | End of each 12-week CGM phase |
| Change in Fasting Plasma Glucose | Change in Fasting Plasma Glucose measured in mmol/L by biochemical analyzer. | Baseline; end of each 12-week CGM phase |
| Change in Body Weight | Change in Body Weight (in kg) from baseline to week twelve (of each CGM phase). | Baseline; end of each 12-week CGM phase |
| Change in Physical Activity Assessed by IPAQ Short Form | Physical activity assessed using the International Physical Activity Questionnaire (IPAQ) short form, reported as total MET-minutes per week. | Baseline; end of each 12-week CGM phase |
| Change in Health Status Assessed by EQ-VAS | Change in Health Status Assessed by EQ-VAS index score (0-100; higher scores indicate better perceived health). | Baseline; end of each 12-week CGM phase |
| Change in Glycated Hemoglobin (HbA1c) | Change in Glycated Hemoglobin (HbA1c) measured in % (according to The National Glycohemoglobin Standardization Program - NGSP) | Baseline; end of each 12-week CGM phase |
| Zala Jenko Pražnikar, PhD | University of Primorska, Faculty of Health Sciences | Study Chair |
| Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia | Recruiting | Koper | 6000 | Slovenia |
|
| Department Of endocrinology and diabetes, Medical Faculty, University of Ljubljana | Recruiting | Ljubljana | 1000 | Slovenia |
|
| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D009765 | Obesity |
| D050177 | Overweight |
| D011236 | Prediabetic State |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
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