Evaluation of CloudCare in the Treatment of Type 1 Diabetes

Recruiting

• Conditions: Type 1 Diabetes

• Registration Number: NCT05431140
• Lead Sponsor: Diabeter Nederland BV

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.

Study Timeline

• Study Start: 2022-06-20
• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-24
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01
• Primary Completion: 2024-12
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 194

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diabetes Treatment Satisfaction Questionnaire (DTSQc)	after 3 and 6 months	Change in mean patient treatment satisfaction score at 3 and 6 months (prospective) using change version of the DTSQc

Secondary Outcome Measures

Name	Time	Method
Time above Range (TAR)	-3 (postspective) , +3 and +6 months (prospective)	Change in mean TAR at 3 and 6 months
Treatment costs of complications requiring hospitalizations	-3 (postspective) , +3 and +6 months (prospective)	Costs for hospitalization
Time below Range (TBR)	-3 (postspective) , +3 and +6 months (prospective)	Change in mean TBR at 3 and 6 months
Problem Areas In Diabetes (PAID-5) questionnaire score	after 3 and 6 months	Change in mean PAID-5 questionnaire score
Change in mean treatment satisfaction score of the HCP satisfaction Questionnaire	after 3 and 6 months	Self developed questionnaire. Not validated
Number of contacts with HCP	-3 (postspective) , +3 and +6 months (prospective)	Number of contacts of patient with HCP during 3 months time period
% HbA1c	-3 (postspective) , +3 and +6 months (prospective)	Change in mean % HbA1c at 3 and 6 months
Number of reported complications requiring hospitalizations	-3 (postspective) , +3 and +6 months (prospective)	Number of Serious Adverse Events (SAEs) that fulfill the definition of hospitalization
Type of contacts with HCP	-3 (postspective) , +3 and +6 months (prospective)	Face to face, Email/Telephone
Time spent by the HCP	-3 (postspective) , +3 and +6 months (prospective)
Time in Range (TIR)	-3 (postspective) , +3 and +6 months (prospective)	Change in mean TIR at 3 and 6 months

Trial Locations

Locations (1)

Diabeter; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands