RecruitingNCT06124196

Wearable Technology to Evaluate Hyperglycemia and Heart Rate Variability in Duchenne Muscular Dystrophy

Sponsor: Vanderbilt University Medical Center

Trial Details

ConditionDuchenne Muscular Dystrophy
Interventionwearable technology
StatusRecruiting
Participants80
Est. Completion1 Feb 2030
Last Updated22 May 2026

Primary Outcome

Rate of hyperglycemia; Standard deviation of the mean R-to-R segment (SDANN)

Eligibility Criteria

Inclusion 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

Trial Sites

Countries

United States
View Registry Entry

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