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Type 1 DiabetesNCT05431140

Evaluation of CloudCare in the Treatment of Type 1 Diabetes

An observational study of Type 1 Diabetes, run by Diabeter Nederland BV at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
CloudCare
Type of treatment
Medical device
How many people
194 participants
Where
1 siteNetherlands
Study dates
20 Jun 2022to Feb 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Henk-Jan Aanstoot, MD contact

+31 882807277

h.j.aanstoot@diabeter.nl

Netherlands1 site, 1 recruiting

  • Diabeter

    Rotterdam, South Holland, 3011 TA

    Henk-Jan Aanstoot, MD, PhD, +0031 620372667, h.j.aanstoot@diabeter.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Conditions
Type 1 Diabetes
Being tested
CloudCare
Keywords
cohort, prospective, observational
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CloudCareDevice

    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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Diabetes Treatment Satisfaction Questionnaire (DTSQc)

    Change in mean patient treatment satisfaction score at 3 and 6 months (prospective) using change version of the DTSQc

    Measured: after 3 and 6 months

Secondary outcomes (11)

  1. % HbA1c

    Change in mean % HbA1c at 3 and 6 months

    Measured: -3 (postspective) , +3 and +6 months (prospective)

  2. Time in Range (TIR)

    Change in mean TIR at 3 and 6 months

    Measured: -3 (postspective) , +3 and +6 months (prospective)

  3. Time above Range (TAR)

    Change in mean TAR at 3 and 6 months

    Measured: -3 (postspective) , +3 and +6 months (prospective)

  4. Time below Range (TBR)

    Change in mean TBR at 3 and 6 months

    Measured: -3 (postspective) , +3 and +6 months (prospective)

  5. Problem Areas In Diabetes (PAID-5) questionnaire score

    Change in mean PAID-5 questionnaire score

    Measured: after 3 and 6 months

  6. Change in mean treatment satisfaction score of the HCP satisfaction Questionnaire

    Self developed questionnaire. Not validated

    Measured: after 3 and 6 months

  7. Number of reported complications requiring hospitalizations

    Number of Serious Adverse Events (SAEs) that fulfill the definition of hospitalization

    Measured: -3 (postspective) , +3 and +6 months (prospective)

  8. Treatment costs of complications requiring hospitalizations

    Costs for hospitalization

    Measured: -3 (postspective) , +3 and +6 months (prospective)

  9. Number of contacts with HCP

    Number of contacts of patient with HCP during 3 months time period

    Measured: -3 (postspective) , +3 and +6 months (prospective)

  10. Type of contacts with HCP

    Face to face, Email/Telephone

    Measured: -3 (postspective) , +3 and +6 months (prospective)

  11. Time spent by the HCP

    Measured: -3 (postspective) , +3 and +6 months (prospective)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2022
  2. Study start20 Jun 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
194 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05431140
Sponsor's protocol ID
DIA-2022-01
Status last verified
Aug 2023
First submitted
21 Jun 2022
Last updated
1 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • van Beers CAJ, Last S, Dekker P, Birnie E, Riegman N, van der Pluijm F, Fransman C, Veeze HJ, Aanstoot HJ. Evaluating cloudcare, a population health management system, in persons with type 1 diabetes: an observational study. BMC Endocr Disord. 2025 Mar 31;25(1):88. doi: 10.1186/s12902-025-01905-4.

    PubMed 40165180

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes, run by Diabeter Nederland BV at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Henk-Jan Aanstoot, MD (+31 882807277, h.j.aanstoot@diabeter.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diabetes Treatment Satisfaction Questionnaire (DTSQc) (time frame: after 3 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05431140, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.

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