Status:
UNKNOWN
AI for Glycemic Events Detection Via ECG in a Pediatric Population
Lead Sponsor:
Bambino Gesù Hospital and Research Institute
Collaborating Sponsors:
University of Warwick
Conditions:
type1diabetes
Pediatrics
Eligibility:
All Genders
4-18 years
Brief Summary
Paediatric Type 1 Diabetes (T1D) patients are at greater risk for developing severe hypo and hyperglycaemic events due to poor glycaemic control and incorrect Insulin administration. To reduce the ris...
Detailed Description
As per inclusion criteria, the study participants continue to use their CGM device they are already using. During their routine diabetes hospital visit, the participants are asked to wear an additiona...
Eligibility Criteria
Inclusion
- Age less than 18 years old
- Diagnosed with type 1 diabetes
- Use of continuous glucose monitoring systems (CGM)
Exclusion
- Use of standard finger prick glucometer to measure glycemic values
- Be pregnant or becoming pregnant during the study
- Coexistence of celiac disease
- Coexistence of non-diabetic hypoglycemia
- Coexistence of cardiovascular pathologies and cardiac arrhythmias
Key Trial Info
Start Date :
April 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 12 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05278143
Start Date
April 12 2021
End Date
April 12 2023
Last Update
March 14 2022
Active Locations (1)
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1
Bambino Gesù Children's Hospital
Rome, Italy, 00165