Clinical trial NCT05431140: Evaluation of CloudCare in the Treatment of Type 1 Diabetes
Official title: Evaluation of CloudCare in the Treatment of Type 1 Diabetes. A Prospective Cohort Study in the Netherlands
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Keywords: cohort
prospective
observational
Lead sponsor: Diabeter Nederland BV
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 194
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQc)
timeFrame: after 3 and 6 months
Secondary outcomes:
measure: % HbA1c
timeFrame: -3 (postspective) , +3 and +6 months (prospective)
measure: Time in Range (TIR)
timeFrame: -3 (postspective) , +3 and +6 months (prospective)
measure: Time above Range (TAR)
timeFrame: -3 (postspective) , +3 and +6 months (prospective)
measure: Time below Range (TBR)
timeFrame: -3 (postspective) , +3 and +6 months (prospective)
measure: Problem Areas In Diabetes (PAID-5) questionnaire score
timeFrame: after 3 and 6 months
measure: Change in mean treatment satisfaction score of the HCP satisfaction Questionnaire
timeFrame: after 3 and 6 months
measure: Number of reported complications requiring hospitalizations
timeFrame: -3 (postspective) , +3 and +6 months (prospective)
measure: Treatment costs of complications requiring hospitalizations
timeFrame: -3 (postspective) , +3 and +6 months (prospective)
measure: Number of contacts with HCP
timeFrame: -3 (postspective) , +3 and +6 months (prospective)
measure: Type of contacts with HCP
timeFrame: -3 (postspective) , +3 and +6 months (prospective)
measure: Time spent by the HCP
timeFrame: -3 (postspective) , +3 and +6 months (prospective)
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Diabeter
state: Zuid-Holland
Study officials:
affiliation: Diabeter Nederland B.V.
name: Henk-Jan Aanstoot, MD
role: PRINCIPAL_INVESTIGATOR
References: