CloudCare in the Treatment of Type 1 Diabetes in Pediatrics

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type1diabetes, Pediatric ALL

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DTSQc | Change in mean treatment satisfaction score at 6 months using change version of the Diabetes Treatment Satisfaction Questionnaire (DTSQc) for Teens and Parents | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DTSQs | Change in mean treatment satisfaction score at 0- 6- and 12-months using status version of the Diabetes Treatment Satisfaction Questionnaire (DTSQs) for Teens and Parents | 0, 6, 12 months | 
| Change in mean % HbA1c |  | -3 months to 3, 6 and 12 months | 
| Change in mean TIR | Time in Range | -3 months to 3, 6 and 12 months | 
| Change in mean TAR | Time Above Range | -3 months to 3, 6 and 12 months | 
| Change in mean TBR | Time Below Range | -3 months to 3, 6 and 12 months | 
| Change in mean PAID-teens and PAID-parent |  | 0, 3, 6 and 12 months | 
| Change in mean QoL score and mean QoL diabetes related score | Quality of Life; 2 questions | 0, 3, 6 and 12 months | 
| Change in mean treatment satisfaction score of the HCP satisfaction Questionnaire | Non-validated satisfaction questionnaire | 0, 3, 6 and 12 months | 
| Treatment costs | Treatment costs of complications requiring hospitalizations Number of contacts with HCP Type of contacts with HCP (Face to face, Email/Telephone) Time spent by the HCP | 0, 3, 6 and 12 months |