CloudCare in the Treatment of Type 1 Diabetes in Pediatrics

NCT06018324 | Unknown

• 1 other identifier: DIA-2023-01
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1diabetes; Pediatric ALL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• DTSQs

  0, 6, 12 months

• Change in mean % HbA1c

  -3 months to 3, 6 and 12 months

• Change in mean TIR

  -3 months to 3, 6 and 12 months

• Change in mean TAR

  -3 months to 3, 6 and 12 months

• Change in mean TBR

  -3 months to 3, 6 and 12 months

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diabeter Nederland BV: lead

Study Sites (1)

Diabeter

Rotterdam, South Holland, 3011 TA, Netherlands

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Henk-Jan Aanstoot, MD, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 30, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

NL (1)