Wearable Technology for Duchenne Muscular Dystrophy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the connection between blood sugar levels and heart problems in individuals with Duchenne muscular dystrophy (DMD). Researchers will use wearable technology to monitor glucose levels and heart rate variability (HRV) to determine if these factors contribute to heart issues in DMD patients. Participants will wear devices to track glucose, heart activity, and sleep patterns. The study is suitable for males aged 10 and older with a doctor-confirmed diagnosis of DMD.
As an unphased trial, this study provides participants the opportunity to contribute to groundbreaking research that could enhance understanding and management of DMD-related heart issues.
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 have been taking insulin or other anti-diabetic drugs in the 4 weeks before the study.
What prior data suggests that this wearable technology is safe for individuals with DMD?
Research has shown that using wearable technology in clinical trials for Duchenne muscular dystrophy (DMD) is generally safe. Studies have confirmed that data from these devices are approved for use in DMD trials. These devices track daily activities and provide important health information without causing harm.
Previous studies collected movement data from boys with DMD using these devices, and no serious side effects were reported. The technology is considered low-risk and helps gather valuable insights about the condition in a non-invasive way.
Overall, wearable technology has been well-received in similar settings, making it a safe choice for participants in clinical trials.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it uses wearable technology to explore new insights into hyperglycemia and heart rate variability (HRV) in individuals with Duchenne Muscular Dystrophy (DMD). Unlike traditional methods that rely on periodic clinical tests, this approach allows for continuous, real-time monitoring of blood sugar levels and HRV. This can lead to a better understanding of how DMD affects metabolic and cardiovascular health over time. By potentially identifying new patterns and correlations, this technology could pave the way for more personalized and effective management strategies for those with DMD.
What evidence suggests that wearable technology is effective for monitoring hyperglycemia and heart rate variability in DMD?
Research shows that wearable technology can help manage Duchenne muscular dystrophy (DMD). Studies indicate that these devices can monitor daily activities and predict disease progression. They might detect changes or complications earlier. In this trial, one group of participants with DMD will use wearable technology to gather data. Some evidence suggests that these devices could improve how doctors check for heart problems in DMD. Wearable tech might also clarify the connection between blood sugar levels and heart health in people with DMD. These insights could lead to better care and new treatment strategies.12346
Who Is on the Research Team?
Jaclyn Tamaroff, MD
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Medical history and record review, and initial setup of monitoring devices
Monitoring
Participants use continuous glucose monitors, cardiac monitors, and activity monitors to evaluate glucose levels, heart rate, activity, and sleep
Follow-up
Participants are monitored for safety and effectiveness after the monitoring period
What Are the Treatments Tested in This Trial?
Interventions
- Wearable Technology
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
40 matched controls (gender, age ± 1 year, BMI category, self-reported race/ethnicity).
40 male individuals with DMD
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Citations
The Black Box of Technological Outcome Measures
We assessed four outcome measures based on devices developed for the gaming industry, aiming to overcome disadvantages of observer-dependency and motivation.
Wearable full-body motion tracking of activities of daily ...
Wearable full-body motion tracking of activities of daily living predicts disease trajectory in Duchenne muscular dystrophy. Valeria Ricotti ...
A Low Interventional Study to Monitor Activity Using ...
The purpose of this low interventional study is to collect data on everyday movement in boys with Duchenne muscular dystrophy (DMD) using wearable activity ...
Wearable Inertial Devices in Duchenne Muscular Dystrophy
The current review describes the use of IMUs for the biomechanical assessment of meaningful outcome measures in individuals affected by Duchenne muscular ...
5.
duchenneuk.org
duchenneuk.org/data-from-wearable-devices-approved-for-use-in-duchenne-muscular-dystrophy-clinical-trials/Data from wearable devices approved for use in ...
Access to treatments. Data from wearable devices approved for use in Duchenne muscular dystrophy clinical trials.
First Regulatory Qualification of a Novel Digital Endpoint in ...
Hip kinetics during gait are clinically meaningful outcomes in young boys with Duchenne muscular dystrophy. Gait Posture. 2016 Jul;48:159–64 ...
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