Duchenne Muscular DystrophyNCT06093100
Wearable Technology to Evaluate Hyperglycemia and HRV in DMD - Longitudinal Aim
An observational study of Duchenne Muscular Dystrophy, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- wearable technology
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2024to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 10 adolescent and young adult males with DMD. DMD affects about 1/3500-6000 males and 1/50million females, therefore only male participants will be enrolled.
Who may be able to join
- Male- ≥10 years
- 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
- Able to undergo non-sedated CMR
Who cannot join
- 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
- Inability to fast for 10 hours
- Use of a pacemaker, implantable cardioverter-defibrillator (ICD), or other implanted device
- Unable to comply with study procedures, in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Jaclyn Tamaroff, MD, 615-875-7853, Jaclyn.tamaroff@vumc.org
Andrea Lee, 615-875-9602, Andrea.e.lee@vumc.org
About this study
Official title: Wearable Technology to Evaluate Hyperglycemia and Heart Rate Variability in Duchenne Muscular Dystrophy
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.
Read the detailed description
Risk for hyperglycemia and insulin resistance in DMD: Individuals with DMD have multiple risk factors for abnormal glucose and insulin metabolism: frequent use of glucocorticoid (GC) medication, decreased ambulation/activity, sarcopenia, and obesity. GC use is known to increase the risk of impaired glucose tolerance (IGT) and insulin resistance (IR) in multiple populations. Decreased skeletal muscle mass and function are associated with impaired skeletal muscle insulin sensitivity and type 2 diabetes (T2D). Despite these risks, there are limited data relating glycemia and IR in this population.
This study is a critical first step in evaluating hyperglycemia in DMD and the relationship to autonomic dysfunction. Our findings will help establish screening guidelines and provide a basis for intervention studies targeting glycemia in DMD. Additionally, this study, along with other ongoing studies (Remote study: Wearable Technology to Evaluate Hyperglycemia and Heart Rate Variability in Duchenne Muscular Dystrophy) will establish wearable technology as investigational tools, for potential use in future clinical trials, in individuals with DMD and neuromuscular diseases.
Study Population: This study will include approximately 10 male participants at Vanderbilt with DMD.
DMD is an X-linked disorder affecting approximately 1/3500-6000 males and 1/50 million females. Therefore, only males will be included in this study.
Study Enrollment Period: Expected duration of the study is 6 years.
Study Visits and procedures:
Visit 1 (V1): in-person study visit
- Participants will arrive to the research clinic after an overnight fast
- Visit includes medical history, physical exam, a fasting oral glucose tolerance test (OGTT), blood will be drawn, dual-energy X-ray absorptiometry (DXA) scan, and cardiac MRI (CMR).
- Participants will wear remote monitoring devices including a continuous glucose monitor (CGM) for up to 10 days, an activity monitor (Actigraph) for up to 7 days, and a Holter (cardiac) monitor for up to 7 days.
- Participants will complete a brief diary/survey twice daily during the 7 days they are wearing the ActiGraph, Holter, and CGM. This survey will be texted or emailed to participants in the morning and evening and take approximately 5 minutes to complete. The questions are primarily related to sleep, activity, and food intake
Visit 2 (V2): remote, 6 months after Visit 1
- Participants will wear remote monitoring devices including a continuous glucose monitor (CGM) for up to 10 days, an activity monitor (Actigraph) for up to 7 days, and a Holter (cardiac) monitor for up to 7 days.
- Repeat the brief diary/survey as V1.
Visit 3 (V3): remote, 12 months after Visit 1
- Same study procedures as V2.
Visit 4 (V4): remote, 18 months after Visit 1
- Same study procedures as V2.
Visit 5 (V5): in-person study visit, approximately 24 months after Visit 1 • Same study procedures as V1.
*If the participant has completed a cardiac MRI or other study procedure for an alternate clinical or research evaluation within a month of other study procedures, the investigators may be able to use that data instead of repeating the study procedure.
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- wearable technology
- Keywords
- Duchenne Muscular Dystrophy, heart failure, cardiomyopathy, hyperglycemia, heart rate variability
- Medical subject headings
- Muscular Dystrophy, Duchenne, Heart Failure, Cardiomyopathies, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable technologyDevice
Also called Continuous glucose monitor (CGM): The Dexcom G6 Pro Continuous Glucose Monitoring System (Dexcom G6 Pro System), Holter Monitor: Body Guardian Mini Remote Monitoring System, Physical activity and sleep monitor: ActiGraph GT9X accelerometers
Three wearable devices
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hyperglycemia
number of glucose measurements ≥140mg/dL over total number of glucoses
Measured: 5 time points, each over 10 days
Standard deviation of the mean R-to-R segment (SDANN)
correlation of rate of hyperglycemia and SDANN, which reflects heart rate variability
Measured: 5 time points, each over 7 days
Secondary outcomes (7)
Coefficient of variation on CGM
variability of glucose levels on CGM measured by coefficient of variation (COV)
Measured: 5 time points, each over 10 days
Rate of significant hyperglycemia
number of glucose measurements ≥200mg/dL over total number of glucoses
Measured: 5 time points, each over 10 days
Activity level
Time spent in sedentary, low intensity, and moderate to vigorous physical activity
Measured: 5 time points, each over 7 days
Standard deviation of normal R to R intervals (SDNN)
correlation of rate of hyperglycemia and SDNN
Measured: 5 time points, each over 7 days
Late gadolinium enhancement (LGE)
correlation of change in SDANN from 0 to 24 months with change in percent LVEF on cardiac MRI from 0 to 24 months
Measured: 2 time points: initially and approximately 2 years later
Left ventricular ejection fraction (LVEF)
correlation of change in SDANN from 0 to 24 months with change in percent LVEF on cardiac MRI from 0 to 24 months
Measured: 2 time points: initially and approximately 2 years later
Insulin sensitivity
correlation between change in rate of hyperglycemia from 0 to 24 months (CGM) with change in insulin sensitivity from 0 to 24 months (oral glucose tolerance test)
Measured: 2 time points: initially and approximately 2 years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start10 Jul 2024
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaclyn Tamaroff, Vanderbilt University Medical Center
- Investigators
- Jaclyn Tamaroff, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093100
- Sponsor's protocol ID
- 231407
- Status last verified
- Nov 2025
- First submitted
- 10 Oct 2023
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Technology to Evaluate Hyperglycemia and Heart Rate Variability in Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT06093100
- Acronym / sponsor ID
- 231407
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- Duchenne Muscular Dystrophy, heart failure, cardiomyopathy, hyperglycemia, heart rate variability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Risk for hyperglycemia and insulin resistance in DMD: Individuals with DMD have multiple risk factors for abnormal glucose and insulin metabolism: frequent use of glucocorticoid (GC) medication, decreased ambulation/activity, sarcopenia, and obesity. GC use is known to increase the risk of impaired glucose tolerance (IGT) and insulin resistance (IR) in multiple populations. Decreased skeletal muscle mass and function are associated with impaired skeletal muscle insulin sensitivity and type 2 diabetes (T2D). Despite these risks, there are limited data relating glycemia and IR in this population.
This study is a critical first step in evaluating hyperglycemia in DMD and the relationship to autonomic dysfunction. Our findings will help establish screening guidelines and provide a basis for intervention studies targeting glycemia in DMD. Additionally, this study, along with other ongoing studies (Remote study: Wearable Technology to Evaluate Hyperglycemia and Heart Rate Variability in Duchenne Muscular Dystrophy) will establish wearable technology as investigational tools, for potential use in future clinical trials, in individuals with DMD and neuromuscular diseases.
Study Population: This study will include approximately 10 male participants at Vanderbilt with DMD.
DMD is an X-linked disorder affecting approximately 1/3500-6000 males and 1/50 million females. Therefore, only males will be included in this study.
Study Enrollment Period: Expected duration of the study is 6 years.
Study Visits and procedures:
Visit 1 (V1): in-person study visit
- Participants will arrive to the research clinic after an overnight fast
- Visit includes medical history, physical exam, a fasting oral glucose tolerance test (OGTT), blood will be drawn, dual-energy X-ray absorptiometry (DXA) scan, and cardiac MRI (CMR).
- Participants will wear remote monitoring devices including a continuous glucose monitor (CGM) for up to 10 days, an activity monitor (Actigraph) for up to 7 days, and a Holter (cardiac) monitor for up to 7 days.
- Participants will complete a brief diary/survey twice daily during the 7 days they are wearing the ActiGraph, Holter, and CGM. This survey will be texted or emailed to participants in the morning and evening and take approximately 5 minutes to complete. The questions are primarily related to sleep, activity, and food intake
Visit 2 (V2): remote, 6 months after Visit 1
- Participants will wear remote monitoring devices including a continuous glucose monitor (CGM) for up to 10 days, an activity monitor (Actigraph) for up to 7 days, and a Holter (cardiac) monitor for up to 7 days.
- Repeat the brief diary/survey as V1.
Visit 3 (V3): remote, 12 months after Visit 1
- Same study procedures as V2.
Visit 4 (V4): remote, 18 months after Visit 1
- Same study procedures as V2.
Visit 5 (V5): in-person study visit, approximately 24 months after Visit 1 • Same study procedures as V1.
*If the participant has completed a cardiac MRI or other study procedure for an alternate clinical or research evaluation within a month of other study procedures, the investigators may be able to use that data instead of repeating the study procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 10 adolescent and young adult males with DMD. DMD affects about 1/3500-6000 males and 1/50million females, therefore only male participants will be enrolled.
Key inclusion criteria (5 listed)
- Male- ≥10 years
- 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
- Able to undergo non-sedated CMR
Key exclusion criteria (5 listed)
- 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
- Inability to fast for 10 hours
- Use of a pacemaker, implantable cardioverter-defibrillator (ICD), or other implanted device
- Unable to comply with study procedures, in the opinion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wearable technologyAlso: Continuous glucose monitor (CGM): The Dexcom G6 Pro Continuous Glucose Monitoring System (Dexcom G6 Pro System), Holter Monitor: Body Guardian Mini Remote Monitoring System, Physical activity and sleep monitor: ActiGraph GT9X accelerometersThree wearable devices | Device | – |
Primary outcome
Rate of hyperglycemia
Time frame: 5 time points, each over 10 days
number of glucose measurements ≥140mg/dL over total number of glucoses
Standard deviation of the mean R-to-R segment (SDANN)
Time frame: 5 time points, each over 7 days
correlation of rate of hyperglycemia and SDANN, which reflects heart rate variability
7 secondary outcomes
Coefficient of variation on CGM
Time frame: 5 time points, each over 10 days
Rate of significant hyperglycemia
Time frame: 5 time points, each over 10 days
Activity level
Time frame: 5 time points, each over 7 days
Standard deviation of normal R to R intervals (SDNN)
Time frame: 5 time points, each over 7 days
Late gadolinium enhancement (LGE)
Time frame: 2 time points: initially and approximately 2 years later
Left ventricular ejection fraction (LVEF)
Time frame: 2 time points: initially and approximately 2 years later
Insulin sensitivity
Time frame: 2 time points: initially and approximately 2 years later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaclyn Tamaroff, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duchenne Muscular Dystrophy, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaclyn Tamaroff, MD (615-875-7853, Jaclyn.tamaroff@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of hyperglycemia (time frame: 5 time points, each over 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.