Real-time Continuous Glucose Monitoring Compared With Intermittent Continuous Glucose Monitoring in People With Type 2 Diabetes Treated With Insulin.

Официальное название

Effectiveness of Using Real-time Continuous Glucose Monitoring Compared With Intermittent Continuous Glucose Monitoring in People With Type 2 Diabetes Treated With Insulin.

Обзор

The objective is to compare the efficacy of TR-CGM versus isCGM in patients diagnosed with T2D who are treated with insulin and use CGM, as defined by time in range between 70 and 180 mg/dL. An open-label clinical trial will be conducted. Patients with T2D who use intermittent glucose monitoring and insulin with poor metabolic control will be included. They will be randomized to continue with isCGM or RT-CGM. The primary outcome: %TIR 70-180 mg/dL.

Подробное описание

All patients diagnosed with type 2 diabetes (T2D) who meet the inclusion criteria will be identified (see inclusion and exclusion criteria). They will then be invited to participate in the study and asked to sign an informed consent form. Demographic data, baseline clinical characteristics, and clinical tests related to metabolic control will be collected.

Visit 0 (V0): Informed consent signature and basal CGM system installation will be verified.

Visit 1 (V1): CGM data will be downloaded. All enrolled patients will receive the same instructions for device use and management of high and low glucose levels, according to standard clinical procedures. Then, randomization will be performed by someone who is blinded to the clinical characteristics of each patient and is not part of the research group. The allocation given by this mechanism cannot be changed by the treating physicians.

* Usual care + TR-CGM group: Patients in this group will receive a continuous interstitial glucose monitoring (CIGM) sensor via the FreeStyle Libre 2 Plus device and LibreLink app® (Abbott Diabetes Care, Inc., Alameda, CA). High alarms greater than 250 mg/dL and low glucose alerts less than 70 mg/dL will be programmed. All participants will be instructed to change their sensor according to the manufacturer's recommendations: every 15 days for the TR-CGM group. * Usual care + CIGM group: Patients in this group will receive a CIGM sensor using the FreeStyle Libre 2 device (Abbott Diabetes Care Inc., Alameda, CA, USA). High alarms \>250 mg/dL and low glucose alerts \<70 mg/dL will be programmed. Additionally, they will be instructed to perform at least eight scans daily to avoid data loss. All participants were instructed to change their sensors according to the manufacturer's recommendations: every 15 days for isCGM.

Standard Care (Applies to Both Groups):

All patients should be assessed by the diabetes clinic's nutrition service, which will provide basic dietary and physical activity recommendations.

All patients will be instructed in basal and/or prandial insulin titration, as appropriate.

Вмешательства

• Устройство real time Continuous Glucose Monitoring
  • Usual care + TR-CGM group: Patients in this group will undergo insertion of a continuous interstitial glucose monitoring (CGM) sensor using the FreeStyle Libre 2 Plus device and LibreLink app® (Abbott Diabetes Care, Inc., Alameda, CA, USA). The sensor will be programmed with high glucose alarms (\>250 mg/dL) and low glucose alerts (\<70 mg/dL). All participants will be instructed to replace their sensor according to the manufacturer's recommendations: every 15 days for TR-CGM.

Первичные конечные точки

• Time in Range [Срок оценки: 12 weeks]

Вторичные конечные точки (6)

• Proportion of patients with a ≥5% increase in TIR [Срок оценки: 12 weeks]
• TAR [Срок оценки: 12 weeks]
• TBR <70 mg/dl [Срок оценки: 12 weeks]
• TBR <54 mg/dl [Срок оценки: 12 weeks]
• Severe hypoglycemia [Срок оценки: 12 weeks]
• Satisfaction with the device [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Minimum age of 35 years.
• HbA1c >7.0%
• Treatment with one or more insulin injections.
• Stable medication regimen for the 3 months prior to study entry.
• Insulin treatment for ≥3 months with a stable dose prior to entry, with fasting blood glucose between 70 and 130 mg/dL.
• Availability of an NFC-enabled smartphone.

Критерии исключения

• Pregnancy or planning to become pregnant during the study period.
• History of bariatric surgery within the year prior to study entry or plans to undergo bariatric surgery during the study.
• Having a condition that would likely require an MRI during the study period.
• Use of medications containing high doses of ascorbic acid (>2000 mg/day), as it may falsely increase sensor readings.
• Concomitant illness or condition that may compromise patient safety, including, but not limited to, serious mental illness, a diagnosed or suspected eating disorder, or any long-term medical/unmanageable disorder.
• GFR less than 30 ml/min.
• Psychiatric condition that interferes with study-related tasks.
• Known (or suspected) significant allergy to medical-grade adhesives.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Колумбия · 1 центр

• Hospital Universitario San Ignacio — Bogotá

Идентификаторы

NCT: NCT07308925 · FM-CIE-1013-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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