Wearable Technology to Evaluate Hyperglycemia and HRV in DMD

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Nov 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how high blood sugar levels (hyperglycemia) and heart rate variability (HRV) may affect heart health in boys with Duchenne muscular dystrophy (DMD), a condition that weakens muscles and can lead to heart problems. Researchers will use wearable technology like continuous glucose monitors and heart monitors to track these factors in boys with DMD compared to boys without the condition. The goal is to understand if there is a connection between high blood sugar and heart issues in DMD, which could help develop new ways to monitor and treat these patients.

To participate in the study, boys must be at least 10 years old and have a confirmed diagnosis of DMD. They should not have diabetes or be taking any diabetes medications. Participants will wear devices that monitor their glucose levels, heart rate, and activity, allowing researchers to gather important information without needing to visit a clinic frequently. This study aims to make research more accessible to families who may face challenges in getting to healthcare appointments, ultimately helping improve care for boys with DMD.

Gender

MALE

Eligibility criteria

• 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