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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type1diabetes; Pediatric ALL

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Henk-Jan Aanstoot, MD, PhD; Phone Number: +0031 620372667; Email: h.j.aanstoot@diabeter.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3011 TA
      • Diabeter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Diabeter Nederland BV

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: DIA-2023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No