Wearable Devices for Diabetes

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how wearable devices like a Fitbit and a continuous glucose monitor (CGM) can track exercise-related activities, such as heart rate and glucose levels, throughout the day. The goal is to determine how these gadgets can help understand and potentially improve daily physical activity. Participants should engage in less than 150 minutes of moderate exercise weekly and be able to walk a block without discomfort. Individuals with stage I-III breast or colorectal cancer who have completed chemotherapy or radiation may join. This trial excludes those who currently have diabetes or use glucose monitoring devices. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance daily health management for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using oral antidiabetic agents or certain types of insulin.

What prior data suggests that these devices are safe for monitoring exercise-related activities?

Research has shown that the Fitbit and continuous glucose monitor (CGM) used in this study are generally safe. Fitbit devices emit very low levels of radiation, safe for everyday use, including during pregnancy. Although there are some data privacy concerns, these do not impact the physical safety of the device.

For CGMs, studies indicate they are safe and eliminate the need for frequent finger-prick blood sugar tests. They offer constant glucose information, which can help prevent very low or high blood sugar levels.

Both devices are easy to use, and no major safety issues have been reported for either.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how wearable tech like Fitbits and Continuous Glucose Monitors (CGMs) can track exercise-related metrics over time. Unlike traditional methods that might only measure heart rate or glucose levels at specific points, these devices offer continuous monitoring, giving a more comprehensive view of how your body responds to physical activity throughout the day. This real-time data could help personalize fitness and health strategies, making them more effective and tailored to individual needs. By understanding these patterns, the trial aims to enhance how we approach exercise and overall health management.

What evidence suggests that using a Fitbit and CGM is effective for monitoring exercise-related activities?

This trial will compare the use of Fitbit devices and Continuous Glucose Monitors (CGMs) for monitoring health-related metrics. Studies have shown that Fitbit devices, used by participants in one arm of this trial, accurately track heart rates and daily activities. They provide detailed information about activity levels and heart patterns throughout the day, helping researchers understand exercise's impact on health.

In another arm of this trial, participants may use Continuous Glucose Monitors (CGMs). Research indicates that CGMs effectively track blood sugar levels over time and are often used to help people with diabetes manage their blood sugar. CGMs provide real-time data, revealing how exercise affects blood sugar levels.678910

Who Is on the Research Team?

KB

Karen Basen-Engquist, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with a BMI of at least 25 who exercise less than 150 minutes per week and can safely do unsupervised physical activity. Participants must be able to walk without pain, have a smartphone with internet, and speak English. Cancer survivors with specific diagnoses who've finished certain treatments can also join.

Inclusion Criteria

Have a smart phone with daily internet access that is compatible with the LibreLink app
Body mass index (BMI) 25 kg/m2
Engage in less than 150 minutes of moderate-intensity PA per week in the past month
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use a continuous activity and heart rate tracker (Fitbit) and continuous glucose monitor (CGM) to monitor daily exercise-related activities

1 year

Follow-up

Participants are monitored for changes in physical activity motivation and other related psychosocial variables

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CGM
  • Fitbit
Trial Overview The study tests how well a Fitbit device and Continuous Glucose Monitor (CGM) track exercise-related activities in daily life. It aims to understand the impact of these devices on managing conditions like diabetes and monitoring health after cancer treatment.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Heart Rate Tracker (Fitbit)Experimental Treatment2 Interventions
Group II: Continuous Glucose Monitor (CGM)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Intermittently Scanned and Real-Time Continuous Glucose ...Real-time continuous glucose monitoring (rtCGM) systems automatically measure glucose and display a recent glucose value. Intermittently scanned continuous ...
Accuracy of continuous glucose monitoring during exercise ...We investigated the accuracy of two different continuous glucose monitoring systems during exercise-related hypoglycemia in an experimental setting.
Advances in Continuous Glucose Monitoring: Clinical ...Continuous glucose monitoring systems have revolutionized diabetes management, significantly improving glycemic control in both Type 1 and Type 2 diabetes.
Real-Time CGM Shows Benefits Over Intermittently ...Real-time continuous glucose monitoring (CGM) demonstrated benefits in terms of time in range, hypoglycemia, and hyperglycemia among patients with type 1 ...
Glucose management for exercise using continuous ...Most common continuous glucose monitoring (CGM) systems measure glucose in the interstitial fluid, providing real-time sensor glucose data, ...
Safety and Functional Integrity of Continuous Glucose ...Unlike traditional finger-stick blood glucose monitoring, CGM delivers a continuous stream of glucose data in numerical and graphical formats that enable ...
Safety Information | The FreeStyle Libre SystemRead safety information regarding your FreeStyle Libre 14 day system, including MRI contraindications, insulin contraindications, and sensor removal ...
Clinical Implications of Real-time and Intermittently Scanned ...Two types of continuous glucose monitoring (CGM) systems are now available: real-time CGM (rtCGM) and intermittently scanned (isCGM).
Effectiveness and Safety of the Intermittently Scanned ...Real-time Continuous Glucose Monitoring (rt-CGM) does not require manual scanning, and it provides predictive alarms for hypo- or hyperglycaemia, thus resulting ...
CGM l Pros and Cons of Continuous Glucose Monitors ...CGM provides continuous, real-time glucose data, eliminating the need for frequent fingerstick checks. It enhances hypoglycemia prevention, improves ...
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