Evaluation of CloudCare in the Treatment of Type 1 Diabetes

NCT ID: NCT05431140

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 194 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-20
• Study Completion Date: 2025-02-28

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 16 and 75 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diabeter Nederland BV

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henk-Jan Aanstoot, MD

Role: PRINCIPAL_INVESTIGATOR

Diabeter Nederland B.V.

Locations

Diabeter

Rotterdam, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Henk-Jan Aanstoot, MD

Role: CONTACT

h.j.aanstoot@diabeter.nl

+31 882807277

Facility Contacts

Henk-Jan Aanstoot, MD, PhD

Role: primary

h.j.aanstoot@diabeter.nl

+0031 620372667

References

van Beers CAJ, Last S, Dekker P, Birnie E, Riegman N, van der Pluijm F, Fransman C, Veeze HJ, Aanstoot HJ. Evaluating cloudcare, a population health management system, in persons with type 1 diabetes: an observational study. BMC Endocr Disord. 2025 Mar 31;25(1):88. doi: 10.1186/s12902-025-01905-4.

Reference Type: DERIVED

PMID: 40165180 (View on PubMed)

Other Identifiers

DIA-2022-01

Identifier Type: -

Identifier Source: org_study_id