NCT05431140

Evaluation of CloudCare in the Treatment of Type 1 Diabetes

Evaluation of CloudCare in the Treatment of Type 1 Diabetes. A Prospective Cohort Study in the Netherlands

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 194 (estimated)
• Sponsor: Diabeter Nederland BV · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

CloudCare is an eHealth application to help health care professionals (HCP) in the management/treatment of type 1 diabetes. The application will automatically check all uploaded glucose parameters from patients glucose monitoring devices and present all these data in a categorized way (using a so called dashboard) to the HCP. In this way the HCP has a direct overview of the condition of her/his patients, and can determine which data request direct action towards the patient and which data do not. It is expected that this system improves outcome and patient experience. In this study this expectation will be studied by measuring the effect of CloudCare on patients' treatment satisfaction, glucose control, HCP satisfaction and the impact on costs.

Detailed description

Diabeter offers a Conformité Européenne (CE) marked eHealth application called CloudCare. This is a customizable care management and decision support system that uses algorithms and automation to help triage clinically relevant cases from all incoming data transmission (data uploads) and improve clinical workflows. This should complement existing clinical care models, like face-to-face meetings. The CloudCare application offers the Health Care Professional (HCP) a better and accurate oversight of the patient's condition, which enables the HCP to contact the patient in a timely manner. CloudCare enables improved use of clinically relevant data by both patients and care team and is expected to improve outcomes and patient experience. This prospective cohort study aims to estimate the effect of the CloudCare application in daily practice on patients' treatment satisfaction, glycaemic control ('glucometric'), HCP satisfaction and the impact on costs.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	CloudCare	Only eligible subjects to whom CloudCare is introduced as part of their new standard care will be enrolled. Participants will not be subjected to extra procedures on top of their standard of care, except that they will be asked to fill out short questionnaires about their treatment satisfaction and the emotional burden caused by diabetes, which are not standard in the participating study locations.

Timeline

• Start date: 2022-06-20
• Primary completion: 2024-12-01
• Completion: 2025-02-01
• First posted: 2022-06-24
• Last updated: 2023-09-01

Locations

1 site across 1 country: Netherlands