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PREdiabetes GLycemic Impact and Data Evaluation (PRE-GLIDE)

14 de mayo de 2026 actualizado por: Nazarii Kobyliak

Evaluation of the Impact of Continuous Glucose Monitoring (CGM) Systems on Glycemic Control in People With Prediabetes: Postmarketing Clinical Study

This prospective, randomized controlled trial evaluates whether real-time continuous glucose monitoring (CGM) improves glycemic control and lifestyle adherence in adults with prediabetes compared to conventional self-monitoring methods over a 3-month period. By analyzing metabolic markers and behavioral data, the study aims to determine the effectiveness of 24-hour monitoring as a personalized tool that increases patient adherence to lifestyle changes compared to conventional SMBG methods.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Prediabetes is considered a critical stage at which effective prevention of the development of diabetes is possible, provided that early detection and adequate glycemic control. International clinical guidelines and multicenter studies suggest that early intensive glycemic control is associated with a better prognosis and a reduced risk of complications. However, standard self-monitoring has limited information on glycemic variability, which is especially important in the early stages of carbohydrate metabolism disorders, including prediabetes. Routine indicators such as fasting blood glucose, 1 and 2 hours after a meal, and glycated hemoglobin (HbA1c) do not always clearly differentiate between diabetes, prediabetes, and normal carbohydrate metabolism. Recently, there has been a need for more comprehensive blood glucose monitoring strategies that cover the entire spectrum of glycemic variability. Continuous glucose monitoring (CGMs) technology provides real-time glucose concentration data, overcoming the limitations of traditional monitoring methods. Recently, not only among people with diabetes, but also among people with prediabetes, there has been an increasing trend towards using CGM as a personal device to monitor glucose levels and promote healthy habits such as increased activity, diet, and sleep. Their motivation is to improve their own glycemic control and avoid the future development of diabetes and its associated complications, to optimize blood glucose levels to achieve peak mental or physical performance, and to use personal monitoring data to develop sustainable behavioral skills. The contactless 24-hour monitoring system is considered a promising tool for personalized glycemic control, but its use in people with prediabetes has not been studied enough This is a prospective, open-label, randomized controlled trial involving 80 adult patients with prediabetes recruited at the Bogomolets National Medical University. Participants were randomized in a 1:1 ratio to either the Real-Time Continuous Glucose Monitoring (CGM group) or the control group (standard Self-Monitoring of Blood Glucose [SMBG] using conventional glucometers). Participants will undergo a 3-month observation period. The use of the assigned monitoring devices (CGM or SMBG glucometer) and pedometers will last for the first 1 month. The study consists of three visits: Visit 1 (baseline), Visit 2 (1 month, end of intervention), and Visit 3 (3 months, follow-up period). During these visits, researchers will collect data on glycated hemoglobin (HbA1c), fructosamine, Cpeptide, HOMA-IR index, lipid profile, anthropometric indicators (body mass index (BMI), waist circumference), bioimpedance measurement, physical activity monitoring using pedometers, and SF-36 questionnaire to assess quality of life.

The gathered data will help determine whether continuous monitoring provided by CGM systems improves glycemic control and increases patient adherence to lifestyle changes compared to conventional SMBG methods.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Ucrania
      • Kyiv, Ucrania, 01601
        • Reclutamiento
        • Bogomolets National Medical University
        • Contacto:
        • Contacto:
      • Kyiv, Ucrania, 01601
        • Reclutamiento
        • University Hospital of Bogomolets National Medical University
        • Contacto:
        • Contacto:

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Age of 18 years and older.
  • Presence of prediabetes diagnosed according to criteria of the American Diabetes Association
  • Persons who treated with diet and exercise alone or metformin on a stabilized dose for at least 3 months before the study;
  • Ability to comply with protocol requirements and maintain a patient diary.
  • Signed informed consent.

Exclusion Criteria:

  • Presence of type 1 or type 2 diabetes;
  • Decompensated liver or kidney diseases (GFR < 45 ml/min/1. 73 m²);
  • Active cardiovascular diseases within 12 months of Visit 1, such as myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study;
  • Endocrine disorders (e.g., Itsenko-Cushing syndrome, acromegaly) that affect glycemia;
  • Pregnancy or lactation;
  • Mental or cognitive impairments that would interfere with study participation;
  • Daily use of any form of steroid medication (oral, inhaled, injected) within the last 3 months;
  • Recent use of any CGM within the last 12 months;
  • Known allergy to sensor materials;
  • 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.

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 paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: CGM group
Participants 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.
Dispositivo: CGM Sibionics
A registered medical device for real-time monitoring of glucose levels in interstitial fluid.
Comparador activo: 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.
Dispositivo: On-Call Extra Glucometer
Capillary glucose monitoring using fingerstick glucometer as per standard care.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in HbA1c level
Periodo de tiempo: at 3 month (end of follow-up period)
HbA1c in %
at 3 month (end of follow-up period)
Changes in Fructosamine level
Periodo de tiempo: at 3 month (end of intervention period)
Fructosamine in μmol/L
at 3 month (end of intervention period)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
HOMA-2IR
Periodo de tiempo: at 3 month (follow-up period) compared to baseline
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php
at 3 month (follow-up period) compared to baseline
insulin sensitivity (%S)
Periodo de tiempo: at 3 month (follow-up period) compared to baseline
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php
at 3 month (follow-up period) compared to baseline
β-cell function (%B)
Periodo de tiempo: at 3 month (follow-up period) compared to baseline
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php
at 3 month (follow-up period) compared to baseline
body mass index (BMI)
Periodo de tiempo: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
weight in kg and height in meters will be combined to report BMI in kg/m^2
at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
waist circumferences (WC)
Periodo de tiempo: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
WC in cm
at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
visceral fat content
Periodo de tiempo: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
visceral fat content using electronic scales-analyzers of body composition Huawei (Smart Scale series 3/3 Pro
at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
Total Cholesterol (TC)
Periodo de tiempo: at 3 month (follow-up period) compared to baseline
TC in mmol/l
at 3 month (follow-up period) compared to baseline
Tryglicerides (TG)
Periodo de tiempo: at 3 month (follow-up period) compared to baseline
TG in mmol/l
at 3 month (follow-up period) compared to baseline
LDL-Cholesterol (LDL-C)
Periodo de tiempo: at 3 month (follow-up period) compared to baseline]
LDL-C in mmol/l
at 3 month (follow-up period) compared to baseline]
Physical activity levels
Periodo de tiempo: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
Daily number of steps as measured by a sealed pedometer
at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
quality-of-life evaluation
Periodo de tiempo: at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
Self-efficacy questionnaire SF-36 (Medical Outcomes Study Short-Form 36).
at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline

Colaboradores e Investigadores

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

Patrocinador

Nazarii Kobyliak

Colaboradores

COR-Medical LLC
Iridium LLC

Investigadores

  • Investigador principal: Nazarii Kobyliak, Bogomolets National Medical University

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 (Actual)

1 de mayo de 2026

Finalización primaria (Estimado)

31 de diciembre de 2026

Finalización del estudio (Estimado)

31 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

14 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de mayo de 2026

Publicado por primera vez (Actual)

20 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de mayo de 2026

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

14 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PRE-GLIDE

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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

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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