CloudCare in the Treatment of Type 1 Diabetes in Pediatrics

Pediatric ALL Clinical Trial

Official title:

CloudCare Patient Reported Outcomes in the Treatment of Type 1 Diabetes in Pediatrics A Prospective Cohort Study in Europe

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06018324
• Other study ID #: DIA-2023-01
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: April 2025

Study information

• Verified date: August 2023
• Source: Diabeter Nederland BV
• Contact: Henk-Jan Aanstoot, MD, PhD
• Phone: +0031 620372667
• Email: h.j.aanstoot[@]diabeter.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Pediatric ALL
• Type1diabetes

Locations

Country	Name	City	State
Netherlands	Diabeter	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Diabeter Nederland BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Change in mean % HbA1c		-3 months to 3, 6 and 12 months
Secondary	Change in mean TIR	Time in Range	-3 months to 3, 6 and 12 months
Secondary	Change in mean TAR	Time Above Range	-3 months to 3, 6 and 12 months
Secondary	Change in mean TBR	Time Below Range	-3 months to 3, 6 and 12 months
Secondary	Change in mean PAID-teens and PAID-parent		0, 3, 6 and 12 months
Secondary	Change in mean QoL score and mean QoL diabetes related score	Quality of Life; 2 questions	0, 3, 6 and 12 months
Secondary	Change in mean treatment satisfaction score of the HCP satisfaction Questionnaire	Non-validated satisfaction questionnaire	0, 3, 6 and 12 months
Secondary	Treatment costs	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	0, 3, 6 and 12 months