NCT06093100

Wearable Technology to Evaluate Hyperglycemia and HRV in DMD - Longitudinal Aim

StatusActive, Not Recruiting

PhaseNot specified

SponsorVanderbilt University Medical Center

Primary completionDec 2029 (estimated)

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Record History

All 9 versions: 8 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

Notable Nov 6, 2026 Eligibility criteria expanded, about 10 words Show 4 more changesShow less
- Enrollment closed, study ongoing
- Secondary endpoints: details revised at 1 of 7 entries
- Study description expanded, about 7 words
- Site details revised
Minor Aug 5, 2025 Site contact updatedv7
Minor Sep 12, 2024 Start date changed from estimate of Aug 2024 to Jul 10, 2024v6
Notable Jun 14, 2024 Start date: May 2024 to Aug 2024v5
Notable Apr 15, 2024 Start date: Mar 2024 to May 2024
- Site contact updated
v4

Show 2 earlier versionsHide 2 earlier versions

Notable Feb 12, 2024 Start date: Jan 2024 to Mar 2024v3
Notable Dec 6, 2023 Trial status: Not Yet Recruiting to Recruiting
- Start date: Nov 2023 to Jan 2024
- Site details revised
v2

Oct 16, 2023 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Rate of hyperglycemia

Timeframe: 5 time points, each over 10 days

Standard deviation of the mean R-to-R segment (SDANN)

Timeframe: 5 time points, each over 7 days

Secondary (7)

Coefficient of variation on CGM

Rate of significant hyperglycemia

Activity level

Standard deviation of normal R to R intervals (SDNN)

Late gadolinium enhancement (LGE)

Show 2 moreShow less

Left ventricular ejection fraction (LVEF)

Insulin sensitivity

Arms and interventions

Devices: wearable technology

Sites

1 site in 1 country

Vanderbilt University Medical CenterNashville, Tennessee, United States

About this trial

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.

Trial details

Enrollment: 10 participants (estimated)
Started: Jul 10, 2024
Study completion: Dec 2030 (estimated)
Eligibility: 10 and older, male only, no healthy volunteers
Design: Observational
Oversight: No data monitoring committee
Conditions: Cardiomyopathies, Heart Failure, Hyperglycemia, Muscular Dystrophy, Duchenne
Official title: Wearable Technology to Evaluate Hyperglycemia and Heart Rate Variability in Duchenne Muscular Dystrophy
First posted: Oct 23, 2023
Registry updated: Nov 12, 2026
Last verified: Nov 2026

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