Dysautonomia in Children With Type 1 Diabetes (DYSDIAB)

Dysautonomia in Children With Type 1 Diabetes: "DysDiab" Single-center Study

Some physiological factors, such as physical activity, or pathological factors, such as sepsis or diabetes, are known to modulate the overall autonomic activity and the individual's intrinsic capacity to regulate their sympathetic and parasympathetic balance. These conditions can alter the physiological autonomic balance, sometimes with positive consequences on the FC-breathing control and blood pressure adjustment, depending on the individual's position and the status of blood volume, but sometimes with deleterious effects, such as poor regulation of sinus cardiac activity and respiration rate.

Cardiovascular autonomic neuropathy is a major complication of type 1 diabetes. Several studies have described autonomic dysfunction in patients with type 1 diabetes, but these data are derived from cohorts of adults and adolescents or short ECG recordings at rest. Moreover, there are often confounding factors such as sedentary/physical activity, overweight, exposure to post-pubertal hormonal peaks, toxic drugs, or cardiac therapy.

These factors don't greatly influence children's autonomic physiological maturation, whereas diabetes can sometimes exist for several years. In this population, the search for cardiac dysautonomia is entirely appropriate.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteer; Dysautonomia in Children With Type 1 Diabetes
• Intervention / Treatment: Diagnostic test: Neurocoach® and Sudoscan®

Detailed Description

The objective of this study is to evaluate the indices of heart rate variability (from a 24-hour Holter and a cutaneous conductance) in children with type 1 diabetes compared with healthy controls matched to sex and age, and to determine whether the occurrence of cardiac dysautonomia is correlated with the duration of diabetes progression.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hugues PATURAL, MD PhD; Phone Number: +33 (0)4 77 82 82 42; Email: hugues.patural@chu-st-etienne.fr
• Study Contact Backup: Name: Meryem BRITAL, CDP; Phone Number: +33 (0)4 77 42 06 83; Email: meryem.brital@chu-st-etienne.fr

Study Locations

• France
  • Saint-Etienne, France, 42055
    • Recruiting
    • CHU de Saint-Etienne
    • Contact: Hugues PATURAL, MD PhD; Phone Number: +33 (0)4 77 82 85 42; Email: hugues.patural@chu-st-etienne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Parents affiliates or entitled to the French Social Security Fund
• Children<18 years with type 1 diabetes followed in consultation at the University Hospital of Saint-Etienne
• Children under 18 years of age, matched for age (±6 months) and sex, without diabetes or dysautonomia (control group), who have not undergone anesthesia within the 2 months preceding the recording and are not receiving any cardiac (beta-blocker) or antiarrhythmic treatment.

Exclusion Criteria:

• Children with a diagnosis of diabetes of less than 5 years' duration at the time of inclusion.
• Children with diseases that affect the central nervous system or brainstem
• Children suffering from a serious pathology of the cardiorespiratory system or during cardiac treatment (cardiopathies, rhythmic disorders)
• Foreign parents or children who don't speak French.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diabetic subjects; 50 pediatric diabetic subjects with at least 5 years of type 1 diabetes).	Diagnostic test: Neurocoach® and Sudoscan®; The objective of this study is to evaluate the indices of heart rate variability (from a 24-hour Holter and a cutaneous conductance) in children with type 1 diabetes compared with healthy controls matched to sex and age, and to determine whether the occurrence of cardiac dysautonomia is correlated with the duration of diabetes progression.
Active Comparator: healthy group; 50 healthy subjects matched for age and sex	Diagnostic test: Neurocoach® and Sudoscan®; The objective of this study is to evaluate the indices of heart rate variability (from a 24-hour Holter and a cutaneous conductance) in children with type 1 diabetes compared with healthy controls matched to sex and age, and to determine whether the occurrence of cardiac dysautonomia is correlated with the duration of diabetes progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HF ECG index value	HF index value (ms2/Hz) of high-frequency heart rate variability in the frequency domain	During 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sympathetic and parasympathetic indices of heart rate variability	Secondary endpoints: Sympathetic and parasympathetic indices of heart rate variability in the linear frequency domains (Ptot, VLF, LF, LF/HF ratio), time domains (SDNN, pNN30, pNN50, rMSSD), and nonlinear domains (Approximate entropy, SD1, SD2, chaos). Quantifying the Mean ESC value (µS) of the hands and feet.	During 24 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: diabetes; dysautonomia
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Autonomic Nervous System Diseases
• Other Study ID Numbers: 25CH195; ANSM (Other Identifier: 2025-A02921-48)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No