Using wearable technology to assess blood sugar and heart health in boys with Duchenne muscular dystrophy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• KER-065 for Duchenne Muscular Dystrophy: safety and potential benefit in boys and men

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• ELEVIDYS safety in Duchenne patients treated after market approval

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• SGT-003 gene therapy for ambulant boys and young men with Duchenne muscular dystrophy (IMPACT DUCHENNE)

  This trial will test whether a single intravenous infusion of SGT-003 can help ambulatory boys and young men with Duchenne muscular dystrophy maintain or improve walking and motor function.

  Recruiting at 4 sites Phase 3 Solid Biosciences Inc. · Little Rock, Arkansas and 6 other locations · NCT07160634

• Evaluating Givinostat for Young Children with Duchenne Muscular Dystrophy

  This study is testing a new drug called Givinostat to see if it's safe and how it works in young children aged 2 to 6 with Duchenne Muscular Dystrophy.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.