Using wearable technology to monitor blood sugar and heart health in boys with Duchenne Muscular Dystrophy
Wearable Technology to Evaluate Hyperglycemia and Heart Rate Variability in Duchenne Muscular Dystrophy
This study is testing how wearable technology can help monitor blood sugar and heart health in boys with Duchenne Muscular Dystrophy to better understand their risks for heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 10 Years and up |
| Sex | Male |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06093100 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the relationship between hyperglycemia, insulin resistance, and heart rate variability in boys with Duchenne Muscular Dystrophy (DMD). It will involve approximately 10 male participants who will use wearable technology to gather data over a six-year period. The study seeks to close knowledge gaps regarding the risk factors for cardiomyopathy in DMD, particularly focusing on how glucose metabolism may be affected. Findings from this research could lead to improved screening and therapeutic strategies for managing heart health in DMD patients.
Who should consider this trial
Good fit: Ideal candidates for this study are males aged 10 years and older with a confirmed diagnosis of Duchenne Muscular Dystrophy.
Not a fit: Patients who have a prior diagnosis of diabetes or are currently on insulin or other anti-diabetic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better screening and treatment options for heart-related complications in boys with Duchenne Muscular Dystrophy.
How similar studies have performed: While this approach is novel in the context of DMD, similar studies using wearable technology for monitoring health metrics have shown promise in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion and Exclusion Criteria: Inclusion criteria * Male- ≥10 years * Clinical phenotype of DMD confirmed with muscle biopsy or genotype. * Informed consent for individuals ≥18 years * Parent/guardian informed consent and child assent for individuals \< 18 years * Able to undergo non-sedated CMR Exclusion Criteria * Refusal to participate * Diagnosis of diabetes prior to the study and/or taking insulin or other anti-diabetic drug therapy in \< 4 weeks prior to treatment * Inability to fast for 10 hours * Use of a pacemaker, implantable cardioverter-defibrillator (ICD), or other implanted device * Unable to comply with study procedures, in the opinion of the investigator.
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Jaclyn Tamaroff, MD — Vanderbilt University Medical Center
- Study coordinator: Jaclyn Tamaroff, MD
- Email: Jaclyn.tamaroff@vumc.org
- Phone: 615-875-7853
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.