CGM Access
BehavioralThe intervention is the access to the real-time glucose via a CGM system.
NCT Number: NCT07455435
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
Diabetes and Glycemic Management:
Cardiovascular Conditions:
Medications Affecting Vascular Function:
Physical Activity Limitations:
Other Exclusions:
The intervention is the access to the real-time glucose via a CGM system.
Time frame: from day 1 to day 20
step count
Time frame: At day 1 and day 20
flow mediated dilation
Time frame: at day 1 and day 20
pulse wave velocity
Time frame: from day 1 to day 20
average blood glucose from the CGM sensor
Contact information is provided by the study sponsor or research team.
University of Hartford
Other
Continuous Glucose Monitoring as a Tool to Promote Physical Activity in Prediabetes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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