Back to search results

Wearable Technology for Hyperglycemia and Heart Rate in Duchenne Muscular Dystrophy

This observational study is looking at how wearable technology can help us understand more about Duchenne Muscular Dystrophy (DMD). Researchers want to see if high blood sugar (hyperglycemia) and changes in heart rate (heart rate variability or HRV) are linked to heart problems in DMD. You would wear three different devices to measure these things. The study aims to find out if these factors contribute to heart failure in DMD, which could lead to better ways to screen for and treat heart issues. This study is for males aged 10 and older who have been diagnosed with DMD. The goal is to establish screening guidelines and help with future studies.

Study design
This is an observational study with 80 participants, including 40 males with DMD and 40 males without DMD, matched by age, gender, BMI, race, and ethnicity.
What's involved
You would have a medical history review and records checked. A continuous glucose monitor (CGM) sensor will be placed on your abdomen, either during a study visit or at home with video guidance.
Compensation
Not stated in the trial record.
Follow-up
Your rate of hyperglycemia will be measured once over 10 days, and heart rate variability will be measured once over 7 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06124196

Wearable Technology to Evaluate Hyperglycemia and HRV in DMD

Recruiting
Not specifiedAges 10+Observational
Vanderbilt University Medical Center
~80 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:wearable technology

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of hyperglycemia
Measured over once over 10 days
+1 more outcome measured

Conditions

Duchenne Muscular Dystrophy

Explore related trials

Duchenne Muscular Dystrophy

NCT06124196

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Vanderbilt University Medical Center

    Nashville, Tennesseestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jaclyn Tamaroff, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Jaclyn Tamaroff, MD
[email protected]
615-875-7853
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
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).

Exclusion

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.
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

What this trial measures

  • Rate of hyperglycemiaonce over 10 days

    number of glucose measurements ≥140mg/dL over total number of glucoses compared between individuals with and without DMD

  • Standard deviation of the mean R-to-R segment (SDANN)once over 7 days

    correlation of rate of hyperglycemia and SDANN, which reflects heart rate variability