Heart-rate and sweat testing for autonomic problems in children with type 1 diabetes
Dysautonomia in Children With Type 1 Diabetes: "DysDiab" Single-center Study
NA · Centre Hospitalier Universitaire de Saint Etienne · NCT07455994
This study will test whether 24-hour heart-rate monitoring and a skin conductance device can detect autonomic nerve dysfunction in children with type 1 diabetes compared with same-age healthy children.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne (other) |
| Locations | 1 site (Saint-Etienne) |
| Trial ID | NCT07455994 on ClinicalTrials.gov |
What this trial studies
Researchers will record 24-hour Holter heart-rate variability and use Sudoscan and Neurocoach® measurements in children with type 1 diabetes and matched healthy controls. Eligible patients must have at least five years of diabetes, and controls are age- and sex-matched children without diabetes or cardiac medications. The main analyses compare heart-rate variability and cutaneous conductance between groups and examine whether abnormalities correlate with duration of diabetes. All testing is noninvasive and performed on an outpatient basis at the hospital.
Who should consider this trial
Good fit: Ideal candidates are French-speaking children under 18 followed at the University Hospital of Saint-Étienne with type 1 diabetes for five years or more, plus healthy same-age, same-sex control children not taking cardiac medications.
Not a fit: Children with less than five years of diabetes, significant neurologic or cardiorespiratory disease, current cardiac rhythm treatments, non-French speakers, or families not covered by French social security are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, this could enable earlier detection and monitoring of cardiac autonomic neuropathy in children with type 1 diabetes, allowing timelier management to reduce complications.
How similar studies have performed: Prior studies in adults and adolescents have shown autonomic dysfunction using heart-rate variability, but long 24-hour recordings combined with Sudoscan in younger children are limited and this exact approach is not yet well validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Saint-Etienne
- Chu de Saint-Etienne — Saint-Etienne, France (RECRUITING)
Study contacts
- Study coordinator: Hugues PATURAL, MD PhD
- Email: hugues.patural@chu-st-etienne.fr
- Phone: (0)4 77 82 82 42
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dysautonomia in Children With Type 1 Diabetes, Healthy Volunteer, diabetes, dysautonomia