Status:
UNKNOWN
CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
Lead Sponsor:
Diabeter Nederland BV
Conditions:
Type1diabetes
Pediatric ALL
Eligibility:
All Genders
1-15 years
Brief 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/caregiv...
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 CloudCa...
Eligibility Criteria
Inclusion
- Parents/caregivers and, depending on local laws and regulations, also the patient are willing to sign the study informed consent form prior to any data collection for this study
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes and using insulin with or without metformin for at least 6 months.
- Age between 1 and 15 years old.
- Use of multiple daily injections of insulin (MDI, with a basal insulin injection and bolus injections) or continuous subcutaneous insulin infusion (CSII) with Flash or Continuous Glucose Monitoring (FGM/CGM), but without CloudCare for at least three months.
- Receiving CloudCare as part of their standard care for at least 6 months.
Exclusion
- Patients with type 1 diabetes on glucose lowering treatments other than insulin with or without metformin.
- Any known factor, condition, or disease that might interfere with study conduct or interpretation of the results, as deemed by the investigator.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06018324
Start Date
September 1 2023
End Date
April 1 2025
Last Update
August 30 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Diabeter
Rotterdam, South Holland, Netherlands, 3011 TA