Type 1 Diabetes Mellitus (T1DM)NCT06707155
Digital Tracking With Auto Data Reporting
An observational study of Type 1 Diabetes Mellitus (T1DM), run by Persei Vivarium at 1 site in Spain.
Trial summary
Type 1 diabetes mellitus is a chronic pathology and represents a constant challenge for children and adolescents with diabetes and their families. The objective of the treatment of DM1 in pediatric age is to achieve and maintain an optimal glycemic control in order to avoid or delay chronic micro- and macrovascular… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus (T1DM)
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jul 2024to 4 Jan 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients from the Hospital Infantil Universitario Niño Jesús diagnosed with type 1 diabetes mellitus who meet the selection criteria and sign the informed consent will be included.
Who may be able to join
- Patients with type 1 diabetes mellitus
- 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
- Patients who are able to handle the application on a smart mobile phone.
- Informed consent is obtained from the patient.
Who cannot join
- Patients who, in the opinion of the investigator will not be able to commit to carrying out the follow-ups or do not have adequate technological skills
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Use of Digital Platforms for the Control of Insulin Treatment in Patients With Type 1 Diabetes Mellitus
Type 1 diabetes mellitus is a chronic pathology and represents a constant challenge for children and adolescents with diabetes and their families.
The objective of the treatment of DM1 in pediatric age is to achieve and maintain an optimal glycemic control in order to avoid or delay chronic micro- and macrovascular complications related to the disease.
Read more
However, currently, despite technological advances and the development of new insulin formulations, the majority of patients are unable to achieve glycemic goals.
In this context, the use of digital tools/platforms that allow remote monitoring of patients and that facilitate telemedicine have shown potential to improve treatment adherence and facilitate continued therapeutic education, improving clinical results with savings in time and associated costs.
Read the detailed description
Patients are enrolled to a prospective, observational Post-Market clinical Follow-up study. This is a pilot study.
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
- Type 1 Diabetes Mellitus (T1DM)
- Keywords
- T1DM, digital platforms, Remote patient monitoring, glycemic control, Caaring
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential for improvement of type 1 diabetes through the use of a digital platform
Percentage of events related to diabetes reported through the use of a digital platform of the total events related to diabetes that occurred between medical visits.
Measured: 12 weeks
Secondary outcomes (10)
Degree of completion of data related to treatments between medical visits
The Degree of completion of data related to treatments between medical is defined as the ratio between the questionnaires requested and completed.
Measured: Day 0 up to Week 12
Degree of completion of data related to intercurrent processes between visits
The Degree of completion by patients of data related to intercurrent processes between is defined as the ratio between the questionnaires requested and completed
Measured: Day 0 up to Week 12
Degree of completion of therapeutic adherence between visits
The Degree of completion of therapeutic adherence by patients between visits is defined as the ratio between the questionnaires requested and completed.
Measured: Weekly up to 12 weeks
Change in the patient's quality of life scale
Change in the patient's quality of life scale the study compared to baseline. Health-Related Quality of Life in children and adolescents: Values (0-100), a higher score reflects a higher health-related quality of life (HRQoL).
Measured: Day 0 and week 12
Degree of completion of the questionnaires
Degree of completion of the questionnaires depending on age and gender, type of treatment and degree of glycemic control
Measured: Week 12
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)
Measured: Day 0 and Biweekly up to 12 weeks
Percentage of patients who complete the study correctly
Percentage of patients who complete the study correctly by completing all questionnaires
Measured: Week 12
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)
Measured: Day 0 and Biweekly up to 12 weeks
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start22 Jul 2024
- Primary completion4 Jan 2025
- Study completion4 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes Mellitus (T1DM)Studies 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
- Other
- Enrolment
- 25 participants (actual)
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
- NCT06707155
- Sponsor's protocol ID
- SUG_ART
- Status last verified
- Jun 2025
- First submitted
- 19 Nov 2024
- Last updated
- 5 Jun 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Use of Digital Platforms for the Control of Insulin Treatment in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06707155
- Acronym / sponsor ID
- SUG_ART
- Conditions
- Type 1 Diabetes Mellitus (T1DM)
- Keywords
- T1DM, digital platforms, Remote patient monitoring, glycemic control, Caaring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Persei VivariumUniversity, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 4 Jan 2025 (actual)
- Study completion
- 4 Jan 2025 (actual)
- First posted
- 27 Nov 2024 (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.
Type 1 diabetes mellitus is a chronic pathology and represents a constant challenge for children and adolescents with diabetes and their families.
The objective of the treatment of DM1 in pediatric age is to achieve and maintain an optimal glycemic control in order to avoid or delay chronic micro- and macrovascular complications related to the disease.
However, currently, despite technological advances and the development of new insulin formulations, the majority of patients are unable to achieve glycemic goals.
In this context, the use of digital tools/platforms that allow remote monitoring of patients and that facilitate telemedicine have shown potential to improve treatment adherence and facilitate continued therapeutic education, improving clinical results with savings in time and associated costs.
Detailed description
Patients are enrolled to a prospective, observational Post-Market clinical Follow-up study. This is a pilot study.
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
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients from the Hospital Infantil Universitario Niño Jesús diagnosed with type 1 diabetes mellitus who meet the selection criteria and sign the informed consent will be included.
Key inclusion criteria (6 listed)
- Patients with type 1 diabetes mellitus
- 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
- Patients who are able to handle the application on a smart mobile phone.
Key exclusion criteria (1 listed)
- Patients who, in the opinion of the investigator will not be able to commit to carrying out the follow-ups or do not have adequate technological skills
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
Potential for improvement of type 1 diabetes through the use of a digital platform
Time frame: 12 weeks
Percentage of events related to diabetes reported through the use of a digital platform of the total events related to diabetes that occurred between medical visits.
10 secondary outcomes
Degree of completion of data related to treatments between medical visits
Time frame: Day 0 up to Week 12
Degree of completion of data related to intercurrent processes between visits
Time frame: Day 0 up to Week 12
Degree of completion of therapeutic adherence between visits
Time frame: Weekly up to 12 weeks
Change in the patient's quality of life scale
Time frame: Day 0 and week 12
Degree of completion of the questionnaires
Time frame: Week 12
Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR
Time frame: Day 0 and Biweekly up to 12 weeks
Percentage of patients who complete the study correctly
Time frame: Week 12
Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR
Time frame: Day 0 and Biweekly up to 12 weeks
Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV
Time frame: Day 0 and Biweekly up to 12 weeks
Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI
Time frame: Day 0 and Biweekly up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Type 1 Diabetes Mellitus (T1DM), run by Persei Vivarium at 1 site 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 1 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: finished, as of the sponsor's last update on 5 Jun 2025. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential for improvement of type 1 diabetes through the use of a digital platform (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 5 Jun 2025.