CloudCare in the Treatment of Type 1 Diabetes in Pediatrics

Diabeter Nederland BV600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Type1diabetes Pediatric ALL

Eligibility

Sex: ALLMin age: 1 YearMax age: 15 Years

Medical Language ↔ Plain English

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.

Locations (1)

Diabeter

Rotterdam, South Holland, Netherlands

Outcomes

Primary Outcomes

DTSQc

Change in mean treatment satisfaction score at 6 months using change version of the Diabetes Treatment Satisfaction Questionnaire (DTSQc) for Teens and Parents

Time frame: 6 months

Secondary Outcomes

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

Time frame: 0, 6, 12 months

Change in mean % HbA1c

Time frame: -3 months to 3, 6 and 12 months

Change in mean TIR

Time in Range

Time frame: -3 months to 3, 6 and 12 months

Change in mean TAR

Time Above Range

Time frame: -3 months to 3, 6 and 12 months

Change in mean TBR

Time Below Range

Time frame: -3 months to 3, 6 and 12 months

Change in mean PAID-teens and PAID-parent

Time frame: 0, 3, 6 and 12 months

Change in mean QoL score and mean QoL diabetes related score

Quality of Life; 2 questions

Time frame: 0, 3, 6 and 12 months

Change in mean treatment satisfaction score of the HCP satisfaction Questionnaire

Non-validated satisfaction questionnaire

Central Contacts

Henk-Jan Aanstoot, MD, PhD

CONTACT

+0031 620372667 h.j.aanstoot@diabeter.nl

Data from ClinicalTrials.gov

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