Clinical trial NCT06018324: CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
Official title: CloudCare Patient Reported Outcomes in the Treatment of Type 1 Diabetes in Pediatrics A Prospective Cohort Study in Europe
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type1diabetes
Pediatric ALL
Lead sponsor: Diabeter Nederland BV
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: DTSQc
timeFrame: 6 months
Secondary outcomes:
measure: DTSQs
timeFrame: 0, 6, 12 months
measure: Change in mean % HbA1c
timeFrame: -3 months to 3, 6 and 12 months
measure: Change in mean TIR
timeFrame: -3 months to 3, 6 and 12 months
measure: Change in mean TAR
timeFrame: -3 months to 3, 6 and 12 months
measure: Change in mean TBR
timeFrame: -3 months to 3, 6 and 12 months
measure: Change in mean PAID-teens and PAID-parent
timeFrame: 0, 3, 6 and 12 months
measure: Change in mean QoL score and mean QoL diabetes related score
timeFrame: 0, 3, 6 and 12 months
measure: Change in mean treatment satisfaction score of the HCP satisfaction Questionnaire
timeFrame: 0, 3, 6 and 12 months
measure: Treatment costs
timeFrame: 0, 3, 6 and 12 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Diabeter
state: Zuid-Holland
Study officials:
References: