NCT06018324

CloudCare in the Treatment of Type 1 Diabetes in Pediatrics

CloudCare Patient Reported Outcomes in the Treatment of Type 1 Diabetes in Pediatrics A Prospective Cohort Study in Europe

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Diabeter Nederland BV · Academic / Other
• Sex: All
• Age: 1 Year – 15 Years
• Healthy volunteers: Not accepted

Summary

This prospective cohort study aims to estimate the effect of the CloudCare application in daily practice on treatment satisfaction and emotional burden for pediatric patients and their parents/caregivers, patients' glycemic control (glucometrics), healthcare professional satisfaction, and the impact on costs. A total of 600 pediatric patients (1-15 years) with type 1 diabetes will be enrolled into the study.

Detailed description

This is a multi center prospective cohort study in Europe with pre- and post-measurements in type 1 diabetes with 12 months follow-up. This study will only include pediatric patients for which CloudCare is part of their (new) standard care of type 1 diabetes. Participants will be enrolled in several hospitals/healthcare organisations in Europe. Participant's data will be retrieved from their medical records and from uploaded data of their medical devices used for their type 1 diabetes treatment. The study will consist of two periods. A 3 months' retrospective period in which data will be retrieved from patients' dossier followed by a 12 months' prospective period after introduction of CloudCare as part of patients' standard care by the treating physician. The 3 months' retrospective period is the control period for the prospective period.

Conditions

• Type1diabetes
• Pediatric ALL

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-12-01
• Completion: 2025-04-01
• First posted: 2023-08-30
• Last updated: 2023-08-30

Locations

1 site across 1 country: Netherlands