CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
- Conditions
- Pediatric ALLType1diabetes
- Registration Number
- NCT06018324
- Lead Sponsor
- Diabeter Nederland BV
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DTSQc 6 months Change in mean treatment satisfaction score at 6 months using change version of the Diabetes Treatment Satisfaction Questionnaire (DTSQc) for Teens and Parents
- Secondary Outcome Measures
Name Time Method Change in mean TAR -3 months to 3, 6 and 12 months Time Above Range
Change in mean treatment satisfaction score of the HCP satisfaction Questionnaire 0, 3, 6 and 12 months Non-validated satisfaction questionnaire
DTSQs 0, 6, 12 months 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
Change in mean % HbA1c -3 months to 3, 6 and 12 months Change in mean TIR -3 months to 3, 6 and 12 months Time in Range
Change in mean PAID-teens and PAID-parent 0, 3, 6 and 12 months Change in mean TBR -3 months to 3, 6 and 12 months Time Below Range
Change in mean QoL score and mean QoL diabetes related score 0, 3, 6 and 12 months Quality of Life; 2 questions
Treatment costs 0, 3, 6 and 12 months * 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
Trial Locations
- Locations (1)
Diabeter
🇳🇱Rotterdam, Zuid-Holland, Netherlands