Type1diabetes Clinical Trial
Official title:
CloudCare Patient Reported Outcomes in the Treatment of Type 1 Diabetes in Pediatrics A Prospective Cohort Study in Europe
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.
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | April 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 15 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Diabeter | Rotterdam | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Diabeter Nederland BV |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Change in mean % HbA1c | -3 months to 3, 6 and 12 months | ||
Secondary | Change in mean TIR | Time in Range | -3 months to 3, 6 and 12 months | |
Secondary | Change in mean TAR | Time Above Range | -3 months to 3, 6 and 12 months | |
Secondary | Change in mean TBR | Time Below Range | -3 months to 3, 6 and 12 months | |
Secondary | Change in mean PAID-teens and PAID-parent | 0, 3, 6 and 12 months | ||
Secondary | Change in mean QoL score and mean QoL diabetes related score | Quality of Life; 2 questions | 0, 3, 6 and 12 months | |
Secondary | Change in mean treatment satisfaction score of the HCP satisfaction Questionnaire | Non-validated satisfaction questionnaire | 0, 3, 6 and 12 months | |
Secondary | 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 |
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