Using wearable technology to assess 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 blood sugar levels and heart health are connected in boys with Duchenne muscular dystrophy using wearable technology to gather data.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 10 Years and up |
| Sex | Male |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06124196 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the relationship between hyperglycemia and heart rate variability in boys with Duchenne muscular dystrophy (DMD). It will involve approximately 40 participants with DMD and 40 matched controls, utilizing continuous glucose monitors to collect data on glucose levels over a period of up to 10 days. The findings are expected to help establish screening guidelines and inform future interventions targeting glycemic control in DMD. The study will also explore the use of wearable technology as a tool for ongoing research in neuromuscular diseases.
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 with a prior diagnosis of diabetes or those currently using insulin or other anti-diabetic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and therapeutic strategies to delay the progression of heart complications in patients with DMD.
How similar studies have performed: While this approach is novel in the context of DMD, similar studies in other populations have shown promise in evaluating the relationship between hyperglycemia and heart health.
Eligibility criteria
Show full inclusion / exclusion criteria
CASE, DMD inclusion criteria: * Male * Age ≥10years * 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 CASE, DMD 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 * Use of a pacemaker, Implantable cardioverter-defibrillator (ICD), or other implanted device * Unable to comply with study procedures, in the opinion of the investigator. CONTROL inclusion criteria: * Male * Age ≥10years * Informed consent for individuals ≥18 years * Parent/guardian informed consent and child assent for individuals \< 18 years * BMI matched by Centers for Disease Control and Prevention (CDC) category (underweight, normal, overweight, obese) to cases. * Self-reported race/ethnicity matched to cases. * No known evidence of diabetes, impaired fasting glucose, or impaired glucose tolerance: * For individuals (all ≥10 years) of age with obesity, we anticipate that they will have hemoglobin A1c (HbA1c) screening based on American Academy of Pediatrics (AAP) recommendations. * Participants will be included if they have a normal HbA1c (\< 5.7%) or if they have an elevated HbA1c (5.7-6.4%) with no evidence of impaired fasting glucose or impaired glucose tolerance on clinically obtained oral glucose tolerance tests (OGTT) (e.g., fasting glucose \<100mg/dL and 2-hour glucose \<140mg/dL). CONTROL, 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 * Use of a pacemaker, Implantable cardioverter-defibrillator (ICD), or other implanted device * Unable to comply with study procedures, in the opinion of the investigator. * Diagnosis of DMD or Becker muscular dystrophy
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.