Clinical trial · Observational
CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
CloudCare Patient Reported Outcomes in the Treatment of Type 1 Diabetes in Pediatrics A Prospective Cohort Study in Europe
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Type1diabetes | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- DTSQc
- timeFrame
- 6 months
- description
- Change in mean treatment satisfaction score at 6 months using change version of the Diabetes Treatment Satisfaction Questionnaire (DTSQc) for Teens and Parents
Secondary outcomes (9)
- measure
- DTSQs
- timeFrame
- 0, 6, 12 months
- description
- 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
- measure
- Change in mean % HbA1c
- timeFrame
- -3 months to 3, 6 and 12 months
- measure
- Change in mean TIR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 15 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available