Evaluation of CloudCare in the Treatment of Type 1 Diabetes

Study Overview
=================
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.

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

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Device: CloudCare


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cohort, prospective, observational