CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
NCT ID: NCT06018324
Last Updated: 2023-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2023-09-30
2025-04-30
Brief Summary
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A total of 600 pediatric patients (1-15 years) with type 1 diabetes will be enrolled into the study.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Any known factor, condition, or disease that might interfere with study conduct or interpretation of the results, as deemed by the investigator.
1 Year
15 Years
ALL
No
Sponsors
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Diabeter Nederland BV
OTHER
Responsible Party
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Locations
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Diabeter
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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Other Identifiers
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DIA-2023-01
Identifier Type: -
Identifier Source: org_study_id
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