Diabetes MellitusGluCaaringNCT06794658
EFFICACY OF REMOTE MONITORING OF PATIENTS WITH DIABETES UNDER INSULIN TREATMENT, BY USING Caaring SOFTWARE
A study testing software in people with Diabetes Mellitus, run by Persei Vivarium at 2 sites in Spain.
Trial summary
The goal of this clinical trial investigation with device is to determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- 11 Dec 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with diabetes mellitus treated with insulin.
- Patients treated with subcutaneous insulin in multiple daily doses or patients treated with subcutaneous insulin in continuous subcutaneous infusion systems
- Patients using a glucose monitoring system
- Patients who are able to complete the study questionnaires
- Informed consent is obtained from the patient.
- For Control group: Patients must have clinical and glucometry data from the 12 weeks prior to their inclusion date available in the Medical Record, and/or through the monitoring platforms of the continuous glucose monitoring devices - For Caaring group: Patients must have sufficient technological skills to use a smartphone.
Who cannot join
- Patients with cognitive or sensory difficulties or with insufficient command of Spanish who, in the opinion of the investigator, makes it difficult to understand the questions or the scales, as long as they do not have a legally authorized representative capable of participating in the study.
- Transient patients in whom it may be anticipated that follow-up will not be completed due to a change of residence.
- Patients Who are participating at the time of recruitment in any other clinical trial. Participation in observational studies will not be an exclusion criteria.
- Patients whose main diagnosis is a poorly controlled mental disorders or other medical illness.
- Patients with terminal illness and/or in palliative care according to the criteria of the SECPAL (Spanish Society of Palliative Care).
- Institutionalized patients
- Patients who are pregnant or breastfeeding.
- Patients whose inclusion is not considered advisable by the investigator's assessment due to they are under specific follow-up in other hospital units (hemodialysis, transplants, etc.) that require mandatory hospital attendance less frequently than once every two months.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, 28009
Patricia Enes Romero, Dr., +34 91 503 59 15, patricia.enes@salud.madrid.org
- Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, Castille and León, 47003
María del Pilar Bahíllo Curieses, PhD, +34-983420000, pilarbahilloc@yahoo.es
María del Pilar Bahíllo Curieses, PhD
About this study
Official title: DETERMINATION OF THE EFFICACY OF REMOTE MONITORING OF PATIENTS WITH DIABETES UNDER INSULIN TREATMENT, BY USING Caaring(r) SOFTWARE
The goal of this clinical trial investigation with device is to determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®.
The main question it aims to answer is if the development of a self-management platform (Caaring®) that enhances the role of the patient with diabetes in the course of their disease will increase the TIR and/or reduce the number of in-person and telephone visits assisted by specialized medical and nursing personnel.
Read more
This is two arms, randomized study. Online telemonitoring group: The follow-up of these patients will be carried out prospectively remotely through the Caaring® platform. And Retrospective Control group: The data of these patients are collected retrospectively from the last 12 weeks prior to their inclusion.
Researchers will compare the assessments between the two groups to see if the software Caaring® improve the TIR and/or reduce the number of visits to the specialist personnel.
Participants with diabetes will:
Use of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) systems. In addition,
Control group patients must have clinical and glucometry data from the 12 weeks prior to their inclusion date available in the Medical Record, and/or through the monitoring platforms of the continuous glucose monitoring devices Caaring group patients must have sufficient technological skills to use a smartphone.
Read the detailed description
This is a longitudinal, comparative non-inferiority, multicenter, with 2 arms Medical Device Clinical Trial.
The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki
- Conditions
- Diabetes Mellitus
- Being tested
- software
- Keywords
- Diabetes Mellitus (DM), Remote patient monitoring, glycemic control, Caaring, Time in Range (TIR), Online telemonitoring, Digital Health, DTx, PROMs, Patient-reported data, real-world data
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
softwareDevice
Also called Caaring
Caaring is an electronic data collection notebook that allows patients to confidentially fill out data/questionnaires on their mobile phone and report them through an application that will be installed on the patient's mobile phone. Besides, This group (G_CAARING) will receive educational and prevention recommendations relative to diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Online telemonitoring group (G_CAARING) | Active comparator | The monitoring and control of these patients will be carried out remotely through the Caaring® platform. Patients will connect to an APP on a mobile phone. They will have to complete the data and questionnaires related to the study variables. Receives: Device: software |
| Retrospective Control group | No intervention | The data of these patients are collected retrospectively from the medical history, from the last 12 weeks prior to their inclusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®.
% acceptable Time in Range (TIR) of glucose measurements defined as the percentage of how long the patient's glucose value was within the target range (70-180 mg/dL)
Measured: 12 weeks
Secondary outcomes (11)
PROs. Changes in Health-related quality of life (HRQOL): EsDQOL
Change in the patient's quality of life scale the study compared to baseline: EsDQOL questionnaire for adults (Value 0-100). A higher score reflects a higher health-related quality of life (HRQoL).
Measured: Day 0 and week 12
PROs. in Health-related quality of life (HRQOL): KINDL
Change in the patient's quality of life scale the study compared to baseline: KINDL and Diabetes-related quality of life questionnaire for pediatrics for the pediatric population (Value 0-100). A higher score reflects a higher health-related quality of life (HRQoL).
Measured: Day 0 and week 12
PROs. Patient satisfaction with the software Caaring
The patient satisfaction will be measured through a specific satisfaction questionnaire created for this purpose. (Value 3-15). A higher score reflects greater satisfaction with software care.
Measured: Week 12
PROs. Variation in clinical parameters of glycemic control: HbA1c
Variation in clinical parameters of glycemic control, HbA1c
Measured: Day 0 and Week 12
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR
Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR (time in range)(70-180 mg/dl)
Measured: Day 0 and Biweekly up to 12 weeks
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR
Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR (time below range) Time < 70 mg/dL
Measured: Day 0 and Biweekly up to 12 weeks
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIT
Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIT (Time in target range), (70-140 mg/dL).
Measured: Day 0 and Biweekly up to 12 weeks
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV
Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV (Coefficient of Variation)
Measured: Day 0 and Biweekly up to 12 weeks
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI
Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI (Glycemic Risk Index).
Measured: Day 0 and Biweekly up to 12 weeks
PROs. Number of Medical Visits
Number of medical visits, calls or interactions with specialist healthcare personnel
Measured: Day 0 and Monthly up to 12 weeks
PROs. Adherence of treatment
Adherence to therapy (insulin)
Measured: Day 0 and Weekly up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start11 Dec 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Persei Vivarium
- Sponsor type
- University, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794658
- Sponsor's protocol ID
- GluCaaring
- Acronym
- GluCaaring
- Status last verified
- Jul 2025
- First submitted
- 17 Dec 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DETERMINATION OF THE EFFICACY OF REMOTE MONITORING OF PATIENTS WITH DIABETES UNDER INSULIN TREATMENT, BY USING Caaring(r) SOFTWARE
- ClinicalTrials.gov ID
- NCT06794658
- Acronym / sponsor ID
- GluCaaring / GluCaaring
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus (DM), Remote patient monitoring, glycemic control, Caaring, Time in Range (TIR), Online telemonitoring, Digital Health, DTx
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Persei VivariumUniversity, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 27 Jan 2025 (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.
The goal of this clinical trial investigation with device is to determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®.
The main question it aims to answer is if the development of a self-management platform (Caaring®) that enhances the role of the patient with diabetes in the course of their disease will increase the TIR and/or reduce the number of in-person and telephone visits assisted by specialized medical and nursing personnel.
This is two arms, randomized study. Online telemonitoring group: The follow-up of these patients will be carried out prospectively remotely through the Caaring® platform. And Retrospective Control group: The data of these patients are collected retrospectively from the last 12 weeks prior to their inclusion.
Researchers will compare the assessments between the two groups to see if the software Caaring® improve the TIR and/or reduce the number of visits to the specialist personnel.
Participants with diabetes will:
Use of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) systems. In addition,
Control group patients must have clinical and glucometry data from the 12 weeks prior to their inclusion date available in the Medical Record, and/or through the monitoring platforms of the continuous glucose monitoring devices Caaring group patients must have sufficient technological skills to use a smartphone.
Detailed description
This is a longitudinal, comparative non-inferiority, multicenter, with 2 arms Medical Device Clinical Trial.
The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online telemonitoring group (G_CAARING) | Active comparator | Device: softwareThe monitoring and control of these patients will be carried out remotely through the Caaring® platform. Patients will connect to an APP on a mobile phone. They will have to complete the data and questionnaires related to the study variables. |
| Retrospective Control group | No intervention | –The data of these patients are collected retrospectively from the medical history, from the last 12 weeks prior to their inclusion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with diabetes mellitus treated with insulin.
- Patients treated with subcutaneous insulin in multiple daily doses or patients treated with subcutaneous insulin in continuous subcutaneous infusion systems
- Patients using a glucose monitoring system
- Patients who are able to complete the study questionnaires
- Informed consent is obtained from the patient.
Key exclusion criteria (8 listed)
- Patients with cognitive or sensory difficulties or with insufficient command of Spanish who, in the opinion of the investigator, makes it difficult to understand the questions or the scales, as long as they do not have a legally authorized representative capable of participating in the study.
- Transient patients in whom it may be anticipated that follow-up will not be completed due to a change of residence.
- Patients Who are participating at the time of recruitment in any other clinical trial. Participation in observational studies will not be an exclusion criteria.
- Patients whose main diagnosis is a poorly controlled mental disorders or other medical illness.
- Patients with terminal illness and/or in palliative care according to the criteria of the SECPAL (Spanish Society of Palliative Care).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| softwareAlso: CaaringCaaring is an electronic data collection notebook that allows patients to confidentially fill out data/questionnaires on their mobile phone and report them through an application that will be installed on the patient's mobile phone. Besides, This group (G_CAARING) will receive educational and prevention recommendations relative to diabetes. | Device | Online telemonitoring group (G_CAARING) |
Primary outcome
Determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®.
Time frame: 12 weeks
% acceptable Time in Range (TIR) of glucose measurements defined as the percentage of how long the patient's glucose value was within the target range (70-180 mg/dL)
11 secondary outcomes
PROs. Changes in Health-related quality of life (HRQOL): EsDQOL
Time frame: Day 0 and week 12
PROs. in Health-related quality of life (HRQOL): KINDL
Time frame: Day 0 and week 12
PROs. Patient satisfaction with the software Caaring
Time frame: Week 12
PROs. Variation in clinical parameters of glycemic control: HbA1c
Time frame: Day 0 and Week 12
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR
Time frame: Day 0 and Biweekly up to 12 weeks
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR
Time frame: Day 0 and Biweekly up to 12 weeks
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIT
Time frame: Day 0 and Biweekly up to 12 weeks
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV
Time frame: Day 0 and Biweekly up to 12 weeks
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI
Time frame: Day 0 and Biweekly up to 12 weeks
PROs. Number of Medical Visits
Time frame: Day 0 and Monthly up to 12 weeks
PROs. Adherence of treatment
Time frame: Day 0 and Weekly up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing software in people with Diabetes Mellitus, run by Persei Vivarium at 2 sites in Spain.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Dominguez (+34 915 004 013, patricia.dominguez@perseivivarium.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®. (time frame: 12 weeks). 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 31 Jul 2025.