Smart sensors track hidden heart risks in duchenne MD
NCT ID NCT06124196
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study uses three wearable devices—a continuous glucose monitor, a heart monitor, and an activity tracker—to see if high blood sugar is linked to heart problems in people with Duchenne muscular dystrophy. Researchers will compare 80 participants with and without DMD. The goal is to understand risk factors for heart failure, the leading cause of death in DMD, without requiring frequent clinic visits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could point to new ways to screen for or delay heart failure in Duchenne muscular dystrophy.
- What could go wrong
- This is an observational study, not a treatment trial. It is small (80 people) and early, so findings may not lead to immediate changes in care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Feb 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Case: 40 adolescent and young adult males with DMD Control: 40 adolescent and young adult males without DMD DMD affects about 1/3500-6000 males and 1/50million females, therefore only male participants will be enrolled.
- Ages
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10 years and older
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
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