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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: CloudCare

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 Type: Observational
• Enrollment (Estimated): 194

Contacts and Locations

• Study Contact: Name: Henk-Jan Aanstoot, MD; Phone Number: +31 882807277; Email: h.j.aanstoot@diabeter.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3011 TA
      • Recruiting
      • Diabeter
      • Contact: Henk-Jan Aanstoot, MD, PhD; Phone Number: +0031 620372667; Email: h.j.aanstoot@diabeter.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A total of 194 adult patients with type 1 diabetes (16-75 years) will be enrolled into the study. 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Diabeter Nederland BV
• Investigators: Principal Investigator: Henk-Jan Aanstoot, MD, Diabeter Nederland B.V.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: cohort; prospective; observational
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: DIA-2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No