Type1diabetesNCT06018324
CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
An observational study of Type1diabetes and Pediatric ALL, run by Diabeter Nederland BV at 1 site in Netherlands.
Trial summary
This prospective cohort study aims to estimate the effect of the CloudCare application in daily practice on treatment satisfaction and emotional burden for pediatric patients and their parents/caregivers, patients' glycemic control (glucometrics), healthcare professional satisfaction, and the impact on costs. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Type1diabetes, Pediatric ALL
- How many people
- 600 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2023to Apr 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 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients with type 1 diabetes (1-15 years). 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
- Parents/caregivers and, depending on local laws and regulations, also the patient are 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 1 and 15 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.
About this study
Official title: CloudCare Patient Reported Outcomes in the Treatment of Type 1 Diabetes in Pediatrics A Prospective Cohort Study in Europe
This prospective cohort study aims to estimate the effect of the CloudCare application in daily practice on treatment satisfaction and emotional burden for pediatric patients and their parents/caregivers, patients' glycemic control (glucometrics), healthcare professional satisfaction, and the impact on costs.
A total of 600 pediatric patients (1-15 years) with type 1 diabetes will be enrolled into the study.
Read the detailed description
This is a multi center prospective cohort study in Europe with pre- and post-measurements in type 1 diabetes with 12 months follow-up. This study will only include pediatric patients for which CloudCare is part of their (new) standard care of type 1 diabetes. Participants will be enrolled in several hospitals/healthcare organisations in Europe. Participant's data will be retrieved from their medical records and from uploaded data of their medical devices used for their type 1 diabetes treatment.
The study will consist of two periods. A 3 months' retrospective period in which data will be retrieved from patients' dossier followed by a 12 months' prospective period after introduction of CloudCare as part of patients' standard care by the treating physician.
The 3 months' retrospective period is the control period for the prospective period.
- Conditions
- Type1diabetes, Pediatric ALL
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
DTSQc
Change in mean treatment satisfaction score at 6 months using change version of the Diabetes Treatment Satisfaction Questionnaire (DTSQc) for Teens and Parents
Measured: 6 months
Secondary outcomes (9)
DTSQs
Change in mean treatment satisfaction score at 0- 6- and 12-months using status version of the Diabetes Treatment Satisfaction Questionnaire (DTSQs) for Teens and Parents
Measured: 0, 6, 12 months
Change in mean % HbA1c
Measured: -3 months to 3, 6 and 12 months
Change in mean TIR
Time in Range
Measured: -3 months to 3, 6 and 12 months
Change in mean TAR
Time Above Range
Measured: -3 months to 3, 6 and 12 months
Change in mean TBR
Time Below Range
Measured: -3 months to 3, 6 and 12 months
Change in mean PAID-teens and PAID-parent
Measured: 0, 3, 6 and 12 months
Change in mean QoL score and mean QoL diabetes related score
Quality of Life; 2 questions
Measured: 0, 3, 6 and 12 months
Change in mean treatment satisfaction score of the HCP satisfaction Questionnaire
Non-validated satisfaction questionnaire
Measured: 0, 3, 6 and 12 months
Treatment costs
- Treatment costs of complications requiring hospitalizations
- Number of contacts with HCP
- Type of contacts with HCP (Face to face, Email/Telephone)
- Time spent by the HCP
Measured: 0, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabeter Nederland BV
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018324
- Sponsor's protocol ID
- DIA-2023-01
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CloudCare Patient Reported Outcomes in the Treatment of Type 1 Diabetes in Pediatrics A Prospective Cohort Study in Europe
- ClinicalTrials.gov ID
- NCT06018324
- Acronym / sponsor ID
- DIA-2023-01
- Conditions
- Type1diabetes, Pediatric ALL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Diabeter Nederland BVUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective cohort study aims to estimate the effect of the CloudCare application in daily practice on treatment satisfaction and emotional burden for pediatric patients and their parents/caregivers, patients' glycemic control (glucometrics), healthcare professional satisfaction, and the impact on costs.
A total of 600 pediatric patients (1-15 years) with type 1 diabetes will be enrolled into the study.
Detailed description
This is a multi center prospective cohort study in Europe with pre- and post-measurements in type 1 diabetes with 12 months follow-up. This study will only include pediatric patients for which CloudCare is part of their (new) standard care of type 1 diabetes. Participants will be enrolled in several hospitals/healthcare organisations in Europe. Participant's data will be retrieved from their medical records and from uploaded data of their medical devices used for their type 1 diabetes treatment.
The study will consist of two periods. A 3 months' retrospective period in which data will be retrieved from patients' dossier followed by a 12 months' prospective period after introduction of CloudCare as part of patients' standard care by the treating physician.
The 3 months' retrospective period is the control period for the prospective period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients with type 1 diabetes (1-15 years). 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.
Key inclusion criteria (5 listed)
- Parents/caregivers and, depending on local laws and regulations, also the patient are 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 1 and 15 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DTSQc
Time frame: 6 months
Change in mean treatment satisfaction score at 6 months using change version of the Diabetes Treatment Satisfaction Questionnaire (DTSQc) for Teens and Parents
9 secondary outcomes
DTSQs
Time frame: 0, 6, 12 months
Change in mean % HbA1c
Time frame: -3 months to 3, 6 and 12 months
Change in mean TIR
Time frame: -3 months to 3, 6 and 12 months
Change in mean TAR
Time frame: -3 months to 3, 6 and 12 months
Change in mean TBR
Time frame: -3 months to 3, 6 and 12 months
Change in mean PAID-teens and PAID-parent
Time frame: 0, 3, 6 and 12 months
Change in mean QoL score and mean QoL diabetes related score
Time frame: 0, 3, 6 and 12 months
Change in mean treatment satisfaction score of the HCP satisfaction Questionnaire
Time frame: 0, 3, 6 and 12 months
Treatment costs
Time frame: 0, 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes and Pediatric ALL, 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 30 Aug 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, PhD (+0031 620372667, 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?
DTSQc (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2023.