Wearable Technology to Evaluate Hyperglycemia and HRV in DMD

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age10+
SponsorVanderbilt University Medical Center

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-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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male

Age ≥10years

Clinical phenotype of DMD confirmed with muscle biopsy or genotype.

Informed consent for individuals ≥18 years

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • wearable technology

    Device

    Three wearable devices

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Case - DMD1 intervention
Group B: Controls1 intervention

Trial outcomes

Primary outcomes

1

Rate of hyperglycemia

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

Time frame
once over 10 days
2

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

correlation of rate of hyperglycemia and SDANN, which reflects heart rate variability

Time frame
once over 7 days

Secondary outcomes

1

Coefficient of variation on CGM

variability of glucose levels on CGM measured by COV compared between individuals with and without DMD

Time frame
once over 10 days
2

Rate of significant hyperglycemia

number of glucose measurements ≥200mg/dL over total number of glucoses compared between individuals with and without DMD

Time frame
once over 10 days
3

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).

Time frame
once over 7 days
4

Standard deviation of normal R to R intervals (SDNN)

correlation of rate of hyperglycemia and SDNN

Time frame
once over 7 days

Other outcomes

Sponsors and contacts

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