Continuous Glucose Monitoring in Prediabetes

ConditionPrediabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Hartford

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

History of cardiovascular disease (myocardial infarction, stroke, heart failure, coronary artery disease)

Trial design

Design model

Parallel

Treatments tested in this trial

  • CGM Access

    Behavioral

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: CGM Blind groupNo intervention 0 interventions
Group B: CGM Unblind groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Physical activity level

step count

Time frame
from day 1 to day 20

Secondary outcomes

1

endothelial function

flow mediated dilation

Time frame
At day 1 and day 20
2

arterial stiffness

pulse wave velocity

Time frame
at day 1 and day 20
3

blood glucose

average blood glucose from the CGM sensor

Time frame
from day 1 to day 20

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: