Continuous Glucose Monitoring in Prediabetes

Официальное название

Continuous Glucose Monitoring as a Tool to Promote Physical Activity in Prediabetes

Обзор

This research explores how wearable glucose monitors might help prevent type 2 diabetes in people at risk of developing the disease. Type 2 diabetes affects more than 1 in 10 Americans and costs the nation $327 billion annually. Even though it's clear that physical activity helps prevent diabetes, and that even small increases in daily movement (like walking or climbing stairs) can significantly lower risk, getting people to be more active remains challenging. A device called a continuous glucose monitor (CGM) might offer a solution. This small wearable sensor tracks blood sugar levels throughout the day and sends the information to a phone or watch. While these devices are already helping people who have diabetes manage their condition better, the investigators want to study if wearing a CGM may encourage at-risk people to become more physically active. The investigators are particularly interested in seeing whether real-time blood sugar data plus education can be an effective tool to promote lifestyle changes, such as walk more steps every day. The study also aims to examine whether using a CGM helps stabilize blood sugar levels in prediabetes. The researchers believe that even short-term use of these monitors could lead to increased physical activity and more stable blood sugar levels, potentially helping prevent diabetes development.

Подробное описание

The current research landscape shows Type 2 diabetes (T2D) as a major public health challenge, affecting more than 10% of Americans with staggering annual costs of $327 billion. Research has clearly established the protective role of physical activity in T2D prevention, with studies showing that even modest increases in daily activity (14 minutes) can reduce T2D risk by 9%, while sedentary behavior like television viewing can significantly increase risk by 30%. These findings underscore the critical importance of physical activity in diabetes prevention strategies.

Continuous Glucose Monitoring (CGM) technology has emerged as a valuable tool in diabetes management, with the American Diabetes Association now recommending its use for diabetes self-management. While CGM's effectiveness in improving blood sugar control among diagnosed T2D patients is well-documented, there's a notable gap in research regarding its potential as a preventive tool. Specifically, no studies have examined whether real-time glucose feedback from CGM devices might encourage increased physical activity among people at risk for developing T2D.

Individuals at risk for type 2 diabetes, such as with prediabetes, were chosen as the study population for several strategic reasons. First, this aligns with a prevention-focused approach, as research shows that lifestyle interventions can effectively delay or prevent diabetes onset in high-risk populations. Second, there's a significant knowledge gap regarding CGM use in prevention - while its benefits for diagnosed diabetes patients are well-documented, its potential as a preventive tool remains unexplored. The study specifically targets individuals with pre-diabetes diagnosis and BMI \> 25, while excluding those with prior CGM experience or who use glucose-affecting medications to ensure valid results. This population choice also addresses health equity concerns, as type 2 diabetes disproportionately affects underserved communities, making prevention strategies particularly valuable for these groups.

Вмешательства

• Поведенческое CGM Access
  The intervention is the access to the real-time glucose via a CGM system.

Первичные конечные точки

• Physical activity level [Срок оценки: from day 1 to day 20]

Вторичные конечные точки (3)

• endothelial function [Срок оценки: At day 1 and day 20]
• arterial stiffness [Срок оценки: at day 1 and day 20]
• blood glucose [Срок оценки: from day 1 to day 20]

Критерии участия

Критерии включения

Adults aged 18 years or older Prediabetes confirmed by the recent lab tests (within three month). If not available, it will be confirmed at lab Body mass index (BMI) >= 25 kg/m2 Ability to provide informed consent Ownership of a smartphone compatible with Dexcom G6 application Willing and able to comply with study procedures for 20 days

Критерии исключения

Diabetes and Glycemic Management:

• Diagnosed type 1 or type 2 diabetes mellitus
• Current use of glucose-lowering medications (metformin, sulfonylureas, GLP-1 agonists, SGLT2 inhibitors, insulin, etc.)
• HbA1c >= 6.5% or fasting plasma glucose >= 126 mg/dL

Cardiovascular Conditions:

• History of cardiovascular disease (myocardial infarction, stroke, heart failure, coronary artery disease)
• Peripheral artery disease
• Uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP > 100 mmHg)
• Raynaud phenomenon or other conditions affecting peripheral vascular assessment
• Atrial fibrillation or other arrhythmias affecting pulse wave velocity measurement

Medications Affecting Vascular Function:

• Current use of vasoactive medications (nitrates, phosphodiesterase inhibitors)
• Recent changes (< 4 weeks) in antihypertensive medications
• Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
• Systemic corticosteroid use

Physical Activity Limitations:

• Physical disability or musculoskeletal condition preventing normal ambulation
• Use of mobility aids (wheelchair, walker, cane)
• Medical advice to limit physical activity

Other Exclusions:

• Pregnancy or lactation
• Active cancer or cancer treatment within the past 5 years (excluding non-melanoma skin cancer)
• Chronic kidney disease (eGFR < 60 mL/min/1.73m2)
• Liver disease (ALT or AST > 3x upper limit of normal)
• Thyroid disease (unless stable on treatment for > 3 months)
• Current participation in a weight loss program or clinical trial
• Skin conditions preventing CGM sensor placement
• Known allergy to CGM adhesive
• Shift work or irregular sleep schedule (may affect CGM patterns)
• Planned travel during study period that would interfere with study visits

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

Двойное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07455435 · 25-01-397

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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