Wearable Technology to Evaluate Hyperglycemia and HRV in DMD

NCT06124196 | Recruiting

• 1 other identifier: 231636
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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-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.

Conditions

Duchenne Muscular Dystrophy

Keywords

Duchenne Muscular Dystrophy; heart failure; cardiomyopathy; hyperglycemia; heart rate variability; remote; controls

Outcome Measures

Primary Outcomes (2)

• Rate of hyperglycemia

  number of glucose measurements ≥140mg/dL over total number of glucoses compared between individuals with and without DMD

  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

  once over 7 days

Secondary Outcomes (4)

• Coefficient of variation on CGM

  once over 10 days

• Rate of significant hyperglycemia

  once over 10 days

• Activity level - measured by ActiGraph

  once over 7 days

• Standard deviation of normal R to R intervals (SDNN)

  once over 7 days

Study Arms (2)

Case - DMD

40 male individuals with DMD

Device: wearable technology

Controls

40 matched controls (gender, age ± 1 year, BMI category, self-reported race/ethnicity).

Device: wearable technology

Interventions

wearable technology DEVICE

Three wearable devices

Also known as: 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

Case - DMD; Controls

Eligibility Criteria

• Age: 10 Years+
• Gender Eligibility Details: 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. Investigators will not obtain confirmation of biological sex and accept all participants as they self-identify.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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).
• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Heart Failure; Cardiomyopathies; Hyperglycemia

Interventions

Wearable Electronic Devices; Exercise Therapy

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Jaclyn Tamaroff, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaclyn Tamaroff, MD

CONTACT

615-875-7853; Jaclyn.tamaroff@vumc.org

Andrea Lee, MA, MLS

CONTACT

615-875-9602; Andrea.e.lee@vumc.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 9, 2023
• Study Start: March 20, 2024
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2031
• Last Updated: August 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)