Duchenne Muscular DystrophyNCT06124196
Wearable Technology to Evaluate Hyperglycemia and HRV in DMD
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 onlyHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- wearable technology
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2024to Feb 2031
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Case: 40 adolescent and young adult males with DMD Control: 40 adolescent and young adult males without DMD DMD affects about 1/3500-6000 males and 1/50million females, therefore only male participants will be enrolled.
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
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, MA, MLS, 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-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.
Read the detailed description
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 (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.
Study Population: This study will include approximately 40 participants with DMD and 40 age/gender/BMI category, race and ethnicity matched participants without 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 procedures (remote or in-person):
- Medical history and record review
- Continuous Glucose Monitor (CGM) A CGM sensor (Dexcom Pro, Dexcom Inc, San Diego, CA) will be placed on the abdomen of each participant during the study visit or sent to the participant's home. 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. The CGM collects glucose data every 5 minutes. Participants will be offered an optional "skin grip" adhesive (Skin Grip, Bountiful, UT) that they have the option to place over the CGM sensor to help keep it in place.
- Activity Monitoring (ActiGraph) Activity and sleep duration will be measured over 1-week using the ActiGraph accelerometers (ActiGraph, LLC, Pensacola, FL). Participants are instructed to wear the monitors on their dominant wrist for 7 days, 24 hours per day. Data is collected via ActiGraph at a rate of 40Hz and analyzed in 15-second epochs (ActiLife version 6.4 software, Pensacola, FL). For both activity and sleep parameters, the minimum valid wear time to utilize the data is 1 weekend day/night and 3 weekday days/nights with at least 6 hours of wear time per day/night.
- Holter (cardiac) Monitoring An extended-wear Holter monitor (Body Guardian Mini, Preventice, Rochester, MN) will be placed by study personnel during in person visits or participants at home. Participants will wear the monitor for 7 days at the same time they are wearing the CGM and ActiGraph. HRV is automatically calculated by the software.
- Diary/electronic survey Participants will be asked to complete a brief diary/survey response (approximately 5-minute survey twice daily). The REDCap survey diary will be texted to participants in the morning and evening via REDCap/Twilio. The diary will include questions related to sleep, activity, and food intake. Participants will be asked to complete the survey for the 7 days that they are wearing both the ActiGraph and the CGM.
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- wearable technology
- Keywords
- Duchenne Muscular Dystrophy, heart failure, cardiomyopathy, hyperglycemia, heart rate variability, remote, controls
- 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
| Study group | Role | What they receive |
|---|---|---|
| Case - DMD | 40 male individuals with DMD Receives: Device: wearable technology | |
| Controls | 40 matched controls (gender, age ± 1 year, BMI category, self-reported race/ethnicity). Receives: Device: wearable technology |
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 compared between individuals with and without DMD
Measured: once 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: once over 7 days
Secondary outcomes (4)
Coefficient of variation on CGM
variability of glucose levels on CGM measured by COV compared between individuals with and without DMD
Measured: once over 10 days
Rate of significant hyperglycemia
number of glucose measurements ≥200mg/dL over total number of glucoses compared between individuals with and without DMD
Measured: once over 10 days
Activity level - measured by ActiGraph
Time spent in sedentary, low intensity, and moderate to vigorous physical activity. Physical activity will be measured over 1-week using the ActiGraph GT9X accelerometers (ActiGraph, LLC, Pensacola, FL).
Measured: once over 7 days
Standard deviation of normal R to R intervals (SDNN)
correlation of rate of hyperglycemia and SDNN
Measured: once over 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start20 Mar 2024
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2031 (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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 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
- NCT06124196
- Sponsor's protocol ID
- 231636
- Status last verified
- May 2026
- First submitted
- 3 Nov 2023
- Last updated
- 22 May 2026
- 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 22 May 2026. 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
- NCT06124196
- Acronym / sponsor ID
- 231636
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- Duchenne Muscular Dystrophy, heart failure, cardiomyopathy, hyperglycemia, heart rate variability, remote, controls
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 9 Nov 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-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.
Detailed description
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 (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.
Study Population: This study will include approximately 40 participants with DMD and 40 age/gender/BMI category, race and ethnicity matched participants without 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 procedures (remote or in-person):
- Medical history and record review
- Continuous Glucose Monitor (CGM) A CGM sensor (Dexcom Pro, Dexcom Inc, San Diego, CA) will be placed on the abdomen of each participant during the study visit or sent to the participant's home. 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. The CGM collects glucose data every 5 minutes. Participants will be offered an optional "skin grip" adhesive (Skin Grip, Bountiful, UT) that they have the option to place over the CGM sensor to help keep it in place.
- Activity Monitoring (ActiGraph) Activity and sleep duration will be measured over 1-week using the ActiGraph accelerometers (ActiGraph, LLC, Pensacola, FL). Participants are instructed to wear the monitors on their dominant wrist for 7 days, 24 hours per day. Data is collected via ActiGraph at a rate of 40Hz and analyzed in 15-second epochs (ActiLife version 6.4 software, Pensacola, FL). For both activity and sleep parameters, the minimum valid wear time to utilize the data is 1 weekend day/night and 3 weekday days/nights with at least 6 hours of wear time per day/night.
- Holter (cardiac) Monitoring An extended-wear Holter monitor (Body Guardian Mini, Preventice, Rochester, MN) will be placed by study personnel during in person visits or participants at home. Participants will wear the monitor for 7 days at the same time they are wearing the CGM and ActiGraph. HRV is automatically calculated by the software.
- Diary/electronic survey Participants will be asked to complete a brief diary/survey response (approximately 5-minute survey twice daily). The REDCap survey diary will be texted to participants in the morning and evening via REDCap/Twilio. The diary will include questions related to sleep, activity, and food intake. Participants will be asked to complete the survey for the 7 days that they are wearing both the ActiGraph and the CGM.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case - DMD | – | Device: wearable technology40 male individuals with DMD |
| Controls | – | Device: wearable technology40 matched controls (gender, age ± 1 year, BMI category, self-reported race/ethnicity). |
Who may qualify
- Ages
- 10 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Case: 40 adolescent and young adult males with DMD Control: 40 adolescent and young adult males without DMD DMD affects about 1/3500-6000 males and 1/50million females, therefore only male participants will be enrolled.
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 | Case - DMD, Controls |
Primary outcome
Rate of hyperglycemia
Time frame: once over 10 days
number of glucose measurements ≥140mg/dL over total number of glucoses compared between individuals with and without DMD
Standard deviation of the mean R-to-R segment (SDANN)
Time frame: once over 7 days
correlation of rate of hyperglycemia and SDANN, which reflects heart rate variability
4 secondary outcomes
Coefficient of variation on CGM
Time frame: once over 10 days
Rate of significant hyperglycemia
Time frame: once over 10 days
Activity level - measured by ActiGraph
Time frame: once over 7 days
Standard deviation of normal R to R intervals (SDNN)
Time frame: once over 7 days
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 22 May 2026.
- 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?
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 22 May 2026. 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: once 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 22 May 2026.