Evaluation of CloudCare in the Treatment of Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431140
• Other study ID #: DIA-2022-01
• Status: Recruiting
• Start date: June 20, 2022
• Est. completion date: February 2025

Study information

• Verified date: August 2023
• Source: Diabeter Nederland BV
• Contact: Henk-Jan Aanstoot, MD
• Phone: +31 882807277
• Email: h.j.aanstoot[@]diabeter.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Diabeter	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Diabeter Nederland BV

Country where clinical trial is conducted

Netherlands, 

Outcome

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