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Wearable Technology to Evaluate Hyperglycemia and HRV in DMD

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years and older
Sex
Male only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 days, 7 days
  • Procedures mentioned: Wearing a device, Phone or video check-ins, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Therefore, this study will leverage remote wearable technologies to overcome these barriers and define the relationship between dysglycemia and DMD-CM."
  • "Additionally, this study, along with other ongoing studies (Wearable Technology to Evaluate Hyperglycemia and Heart Rate Variability in Duchenne Muscular Dystrophy - longitudinal aim) will establish wearable technology as investigational tools, for potential use in future clinical trials, in individuals with DMD and neuromuscular diseases."
  • "If the CGM sensor is placed remotely, the process of CGM placement will be reviewed over a video call with study staff."
  • "Participants will wear the CGM for up to 10 days (blinded) then return it via pre-paid envelope."
  • "Participants are instructed to wear the monitors on their dominant wrist for 7 days, 24 hours per day."
  • "Participants will wear the monitor for 7 days at the same time they are wearing the CGM and ActiGraph."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This remote study uses wearable monitors to compare high blood sugar in males ages 10 and older with Duchenne muscular dystrophy (DMD), a disease that causes muscle loss, and a comparison group. It also looks at how high blood sugar relates to changes in the time between heartbeats. Participants wear monitors that track blood sugar, heart rate, activity, and sleep.

Duchenne muscular dystrophy (DMD) is an X-linked disorder that causes muscle wasting, cardiopulmonary failure, and premature death. Heart failure is a leading cause of death in DMD, but substantial knowledge gaps exist regarding predisposing risk factors. In the general population, hyperglycemia, insulin resistance, and decreased heart rate variability (HRV; reflecting autonomic dysfunction) are associated with cardiomyopathy (CM). It is unclear whether these factors are associated with DMD-CM. Closing this knowledge gap may lead to novel screening and therapeutic strategies to delay progression of DMD-CM, now the leading cause of death in patients with DMD. Despite risk factors for hyperglycemia, including the use of glucocorticoids (GCs), sarcopenia, obesity, and reduced ambulation, little is known regarding glucose abnormalities in DMD. Some of these same risk factors, along with the distance needed to travel for specialty care, present significant barriers to research participation and clinical care for individuals with DMD. Remote wearable technology may improve research participation in this vulnerable population. Therefore, this study will leverage remote wearable technologies to overcome these barriers and define the relationship between dysglycemia and DMD-CM. The goal of this remote study is to evaluate rates of hyperglycemia in individuals with DMD compared to control participants using continuous glucose monitors, and to determine the relationship between hyperglycemia and heart rate variability. Participants will utilize continuous glucose monitors, cardiac monitors, and activity monitors to evaluate glucose levels, heart rate, activity, and sleep.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: Must be male and at least 10 years old.
  • Both groups: Adults must agree to join. For children under 18, a parent or guardian must give permission, and the child must agree.
  • DMD group: Must have signs of DMD confirmed by a muscle sample test or genetic test.
  • Comparison group: Must match DMD participants by body mass index (BMI) category: underweight, normal weight, overweight, or obese.
  • Comparison group: Must match DMD participants by self-reported race and ethnicity.
  • Comparison group: Must have no known diabetes or problems with blood sugar after fasting or a sugar drink test.
  • Comparison group: For those with obesity, the study expects an HbA1c test, which measures average blood sugar. The result must be below 5.7%, or 5.7–6.4% with a normal sugar drink test: fasting blood sugar below 100 mg/dL and blood sugar below 140 mg/dL after 2 hours.

Who can't join

  • Both groups: Do not agree to take part.
  • Both groups: Had diabetes before the study or used insulin or other diabetes medicine within 4 weeks before treatment.
  • Both groups: Have a pacemaker, an implanted heart shock device (ICD), or another implanted device.
  • Both groups: The study doctor thinks you cannot follow the study steps.
  • Comparison group: Have DMD or Becker muscular dystrophy, another disease that causes muscle weakness.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

TN