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NCT06093100 · ClinicalTrials.gov registry record
Wearable Technology to Evaluate Hyperglycemia and HRV in DMD - Longitudinal Aim
A clinical trial of Duchenne Muscular Dystrophy, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- 10
- Enrollment target
- 1
- Study location
NCT06093100: Recruiting study of Duchenne Muscular Dystrophy, sponsored by Vanderbilt University Medical Center.
NCT06093100 is a study of Duchenne Muscular Dystrophy that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 10 participants, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06093100, a study of Duchenne Muscular Dystrophy, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
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 related CM. Despite risk factors for hyperglycemia, including the use of glucocorticoids, low muscle mass, 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. In this Aim of the study, the investigators will assess the utility of remote wearable technology to predict changes in traditional metrics of metabolism and cardiac function. In this pilot study, 10 individuals with DMD will undergo cardiac magnetic resonance imaging (CMR) and oral glucose tolerance tests (OGTTs) at baseline and two years. The investigators will remotely assess glycemia (using continuous glucose monitors), HRV (using extended Holter monitors), and activity (using accelerometers) every 6 months over the 2 years and evaluate if changes in wearable metrics predict changes in CMR and OGTT.
Primary Outcome
number of glucose measurements ≥140mg/dL over total number of glucoses
Conditions Studied
Interventions
- DEVICE wearable technology
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-07-10 |
| Est. Completion | 2030-12 |
What NCT06093100 shows while recruiting
NCT06093100 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which wearable technology is the first listed.
NCT06093100 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06093100 about?
NCT06093100 is a clinical study titled "Wearable Technology to Evaluate Hyperglycemia and HRV in DMD - Longitudinal Aim". 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, in...
What is the current status of trial NCT06093100?
This trial is currently recruiting. The enrollment target is 10 participants. The study started on 2024-07-10. Estimated completion is 2030-12.
What conditions does trial NCT06093100 study?
This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.
What interventions are being tested in trial NCT06093100?
The interventions under investigation include: wearable technology (DEVICE).
Who is sponsoring clinical trial NCT06093100?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06093100 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06093100's enrollment target sits among peer trials
10 43rd of 48 higher than 6 of 48 other Duchenne Muscular Dystrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Duchenne Muscular Dystrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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