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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.
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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients with type 1 diabetes (1-15 years). All participants must be treated with multiple daily injections of insulin (MDI) or continuous subcutaneous insulin infusion (CSII) with continuous or flash glucose monitoring (CGM/FGM) for at least three months without CloudCare and will get CloudCare as part of their standard care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henk-Jan Aanstoot, MD, PhD | Contact | +0031 620372667 | h.j.aanstoot@diabeter.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabeter | Rotterdam | South Holland | 3011 TA | Netherlands |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| -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 |
| 0, 3, 6 and 12 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |