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El Impacto de la Monitorización Continua de Glucosa en la Variabilidad Glucémica y la Pérdida de Peso en Individuos con Prediabetes y Obesidad (CGM)

30 de octubre de 2026 actualizado por: Zala Jenko Praznikar, University of Primorska

El Impacto de la Monitorización Continua de Glucosa en el Cambio Conductual, la Variabilidad de la Glucosa y la Pérdida de Peso en Individuos con Prediabetes y Obesidad: un Estudio Cruzado Aleatorizado

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.

Descripción general del estudio

Estado

Suspendido

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

34

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Eslovenia
      • Izola, Eslovenia, 6310
        • University of Primorska, Faculty of Health Sciences
      • Koper, Eslovenia, 6000
        • Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia
      • Ljubljana, Eslovenia, 1000
        • Department Of endocrinology and diabetes, Medical Faculty, University of Ljubljana

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: CGM Abierto
Dispositivo: Continuous Glucose Monitoring (CGM)

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.
Experimental: CGM Ciego
Dispositivo: Continuous Glucose Monitoring (CGM)

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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Glycemic Variability Assessed by Coefficient of Variation from CGM
Periodo de tiempo: 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 (%)
End of each 12-week CGM phase
Postprandial Glucose Excursions Measured by CGM
Periodo de tiempo: End of each 12-week CGM phase

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
Periodo de tiempo: End of each 12-week CGM phase

Change in mean daily caloric intake assessed using participant-completed food diaries. Unit of Measure: kcal/day
End of each 12-week CGM phase

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Time in Tight Range (3.9-7.8 mmol/L) Measured by Continuous Glucose Monitoring
Periodo de tiempo: End of each 12-week CGM phase

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
Change in Glycemic Variability Assessed by Standard Deviation from CGM
Periodo de tiempo: End of each 12-week CGM phase

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
Periodo de tiempo: End of each 12-week CGM phase

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
Periodo de tiempo: End of each 12-week CGM phase

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
Periodo de tiempo: End of each 12-week CGM phase

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
Periodo de tiempo: End of each 12-week CGM phase

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
Periodo de tiempo: Baseline; end of each 12-week CGM phase

Change in Fasting Plasma Glucose measured in mmol/L by biochemical analyzer.
Baseline; end of each 12-week CGM phase
Change in Body Weight
Periodo de tiempo: Baseline; end of each 12-week CGM phase

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
Periodo de tiempo: Baseline; end of each 12-week CGM phase

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
Periodo de tiempo: Baseline; end of each 12-week CGM phase

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)
Periodo de tiempo: Baseline; end of each 12-week CGM phase

Change in Glycated Hemoglobin (HbA1c) measured in % (according to The National Glycohemoglobin Standardization Program - NGSP)
Baseline; end of each 12-week CGM phase

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Primorska

Colaboradores

University Medical Centre Ljubljana
Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia

Investigadores

  • Investigador principal: Ajda Urbas, MD, Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia
  • Silla de estudio: Mojca Jensterle Sever, PhD, University Medical Centre Ljubljana, Department Of endocrinology and diabetes, Medical Faculty, University of Ljubljana
  • Silla de estudio: Zala Jenko Pražnikar, PhD, University of Primorska, Faculty of Health Sciences

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de diciembre de 2026

Finalización primaria (Estimado)

1 de diciembre de 2027

Finalización del estudio (Estimado)

1 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

26 de enero de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de febrero de 2026

Publicado por primera vez (Actual)

20 de febrero de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CGM

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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