Type 1 Diabetes (T1D)Diactive-1v2NCT07290868
Diactive-1: Scaled-up Personalized mHealth Program for Youth With Type 1 Diabetes
A study testing Diactive-1 in people with Type 1 Diabetes (T1D), run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
The Diactive-1 project aims to establish the Diactive-1 mobile application as a clinical tool for managing type 1 diabetes in children and adolescents in several hospitals from Spain. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Diactive-1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jan 2026to Mar 2027
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with Type 1 Diabetes Mellitus (T1DM) for 6 months or longer (requiring >0.5 U/kg/day of insulin and having HbA1c >6%, i.e., not in the "honeymoon phase").
- Receiving multiple daily injection (MDI) therapy or insulin pump therapy (CSII).
- Signed informed consent authorizing legal participation in the research project (child/adolescent and parent(s)/legal guardian).
- Availability to participate in the study using an m-Health application (Diactive-1) designed for the programming of muscle-bone strengthening physical exercise.
- Understanding of Spanish.
Who cannot join
- Comorbidities that limit the ability to engage in physical activity.
- Lack of internet access when using the application, whether due to Wi-Fi, mobile data, or international roaming issues.
- Absence of a mobile phone or tablet with an Android or iOS (Apple) operating system, or no family member willing to lend a device for each session using the application for study-related purposes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scaling up Personalized mHealth-supported Resistance Training and Education for Children and Adolescents With Type 1 Diabetes: The Diactive-1 v2.0 Randomized Controlled Trial
The Diactive-1 project aims to establish the Diactive-1 mobile application as a clinical tool for managing type 1 diabetes in children and adolescents in several hospitals from Spain. The successful implementation of the app in new healthcare centers nationwide represents a key step toward the development of a comprehensive and scalable program. This approach seeks not only to optimize current patient care but also to democratize access to an innovative, evidence-based intervention that supports daily diabetes management.
In this new phase, the project will integrate the application into routine clinical care for patients with type 1 diabetes through the use of a simple handgrip strength measurement. A dedicated web platform (www.diactive.es) is being developed to allow clinicians to enter basic patient data, including handgrip strength, sex, and email address. Based on this information, the system will automatically generate a personalized download link for the Diactive-1 app, accompanied by tailored guidance and an initial fitness level classification (low, medium, or high) according to European reference values.
This process will define each user's baseline fitness level and facilitate the use of Diactive-1 as an integrated and individualized disease management tool. The ultimate goal is to strengthen clinical decision-making, improve patient engagement, and extend the benefits of digital health to a broader pediatric population living with type 1 diabetes.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Diactive-1
- Keywords
- mHealth, Resistance training, Education, Handgrip strength
- 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.
Diactive-1Device
Participants will engage in a 12-week resistance exercise program with the goal of maintaining at least 3 sessions per week, with 3-6 exercises per session (≈13-33 minutes). Participants will be able to choose among three training formats, traditional resistance training, Tabata/high-intensity intervals, or circuit training, and may perform the sessions individually or in pairs, depending on preference and feasibility at the center. The training intervention will comprise 3-4 sets of 6-12 repetitions and will consist of a combination of exercises for the upper body, lower body, and core, using primarily the participants' own body weight. The load and intensity of the exercise will be adjusted according to the number of repetitions and the difficulty/progression of the selected exercises. A mobile application (Diactive-1) will be used to deliver, monitor, and record the sessions.
| Study group | Role | What they receive |
|---|---|---|
| Diactive-1 | Experimental | The intervention in the experimental group will center around the use of a mobile application (i.e., device), namely the Diactive-1 app. Receives: Device: Diactive-1 |
| Waiting-list control group | No intervention | This arm will not complete an intervention. Participants will be instructed to continue to follow their normal daily diabetes care plan (i.e., standard care). This group will be granted access to the app following the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in handgrip strength
Handgrip strength measured in kilograms using the Takei III Smedley Type Digital Dynamometer
Measured: Baseline and 12 weeks
Secondary outcomes (23)
Change in daily insulin dose requirement
The daily insulin dose requirements will be measured in units per kilogram of body weight. Assessment will rely on participant-reported data from insulin pumps or injection logs, gathered for 7 days prior to the intervention and after the intervention.
Measured: Baseline and 12 weeks
Change in glycated hemoglobin
Glycated hemoglobin (measured in percent)
Measured: Baseline and 12 weeks
Number of participants with good glycemic control
Number of participants with a glycated hemoglobin level lower than 7%
Measured: Baseline and 12 weeks
Change in time in range
The percentage of time a person spends with their blood glucose levels in the target range (70-180 mg/dL or 3.9-10 mmol/L) (measured in percent)
Measured: Baseline and 12 weeks
Change in time below range
The percentage of time a person spends with their blood glucose levels below the target range (<70 mg/dL or <3.9 mmol/L, i.e., hypoglycemia) (measured in percent)
Measured: Baseline and 12 weeks
Change in time above range
The percentage of time a person spends with their blood glucose levels above the target range (>180 mg/dL or 10 mmol/L, i.e., hyperglycemia) (measured in percent).
Measured: Baseline and 12 weeks
Change in glycemic variability
Glycemic variability measures the fluctuation in blood glucose levels over time, expressed as a percentage. Lower glycemic variability indicates more stable levels, while higher glycemic variability suggests greater fluctuations.
Measured: Baseline and 12 weeks
Change in compliance with 24-hour movement behaviors
Physical activity at different intensities (average min/day), sedentary time (average min/day) and sleep (average min/day) will be measured using self-reported questionnaires.
Measured: Baseline and 12 weeks
Change in self-reported physical activity
Aerobic and muscle-strengthening activities will be assessed using two separate ad hoc questions. Participants will have response options ranging from 0 to 7 days per week, with increments of 1 day.
Measured: Baseline and 12 weeks
Change in self-reported physical fitness
The International Fitness Scale (IFIS) will be used to assess self-reported physical fitness. This scale includes five elements that will employ a 5-point Likert scale to inquire about children's overall perception of their physical fitness, as well as their perception of their cardiorespiratory fitness, muscular fitness, speed-agility, and flexibility compared to their peers. The Likert scale will provide choices ranging from 'very poor' to 'poor,' 'average,' 'good,' and 'very good' physical fitness.
Measured: Baseline and 12 weeks
Change in sleep duration
Sleep duration will be determined by recording the number of hours slept each day
Measured: Baseline and 12 weeks
Change in physical literacy
Physical literacy will be assessed using the Spanish Perceived Physical Literacy Instrument (S-PPLI), a 9-item questionnaire that evaluates three dimensions: knowledge and understanding; self-expression and communication; and sense of self and self-confidence
Measured: Baseline and 12 weeks
Change in physical activity barriers
We will use the Spanish adaptation of the Physical Activity Barriers Scale for pediatric type 1 diabetes (PABS-1), a validated instrument for assessing perceived barriers to physical activity in children and adolescents with type 1 diabetes
Measured: Baseline and 12 weeks
Adherence to the Mediterranean Diet
For assessing adherence to the Mediterranean Diet, the KIDMED index will be employed. This index provides a score on a scale of 0 to 12, with higher scores indicating stronger adherence.
Measured: Baseline and 12 weeks
Change in disordered eating
Disordered eating will be screened using the mSCOFF questionnaire. This questionnaire consists of six straightforward yes/no questions. A positive response to two or more of these questions suggests a potential eating disorder, often requiring further evaluation.
Measured: Baseline and 12 weeks
Change in subjective well-being
Subjective well-being will be assessed using the CUBE questionnaire, which comprises five items that evaluate different aspects of life satisfaction and emotional states.
Measured: Baseline and 12 weeks
Change in Health-Related Quality of Life
Health-Related Quality of Life will be evaluated using the Screening for and Promotion of Health-Related Quality of Life in Children and Adolescents (KIDSCREEN-10).
Measured: Baseline and 12 weeks
Change in Health-Related Quality of Life in the context of a chronic illness
Health-Related Quality of Life in the context of a chronic illness will be evaluated using the Spanish version of the 'Questionnaire for Young People with Diabetes' (DISABKIDS).
Measured: Baseline 12 weeks
Change in microalbuminuria
Microalbuminuria will be evaluated as an indicator of early kidney involvement. A first-morning urine sample will be collected, and the albumin-to-creatinine ratio (ACR) will be determined using standardized laboratory procedures. Values will be expressed in mg/g. Microalbuminuria will be defined as an ACR between 30 and 300 mg/g, according to international diabetes guidelines.
Measured: Baseline and 12 weeks
Change in retinal findings
Retinal imaging will be performed to assess early signs of diabetic retinopathy. Images of both eyes will be captured following standard ophthalmologic protocols and evaluated by trained specialists. Findings will be categorized as no retinopathy, mild, moderate, or severe diabetic retinopathy, based on international classification criteria.
Measured: Baseline and 12 weeks
Change in body mass index
Weight and height will be combined to report body mass index in kg/m^2
Measured: Baseline and 12 weeks
App usability: user
The usability of the app will be evaluated using the Spanish Version of the User Version of the Mobile Application Rating Scale (uMARS).
Measured: 12 weeks
App usability: expert evaluation
We will employ the Spanish adaptation of the Mobile Application Rating Scale (MARS), a standardized instrument for expert appraisal of mHealth applications.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start28 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes (T1D)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Pública de Navarra, University of Valencia, Fundación Instituto de Investigación Sanitaria de Navarra
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290868
- Sponsor's protocol ID
- AGH_Diactive1_2025
- Acronym
- Diactive-1v2
- Status last verified
- Oct 2026
- First submitted
- 15 Dec 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez-Arlegui A, Munoz-Pardeza J, Hormazabal-Aguayo I, Abio-Abero S, Bertholt-Zuber ML, Alonso-Rubio P, Burillo-Sanchez E, Chueca-Guindulain MJ, Cifuentes-Zamalloa C, Congost-Marin S, Diez-Lopez I, Ferrer-Lozano M, Garcia-Navas P, Gonzalez-Garcia LG, Huidobro-Fernandez B, Lalaguna-Mallada P, Llorente-Cereza MT, Maeso-Mendez S, Riano-Galan I, Ruiz-Del Campo M, Salcedo Fresneda O, Vara-Callau M, Vela-Desojo A, Ezzatvar Y, Garcia-Hermoso A. Scale-up of the Diactive-1 mHealth program integrating tailored resistance training as an educational strategy for self-management in children and adolescents with type 1 diabetes: protocol for an 11-hospital multicenter randomized controlled trial. Front Endocrinol (Lausanne). 2026 Aug 14;17:1913568. doi: 10.3389/fendo.2026.1913568. eCollection 2026.
PubMed 42666156
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling up Personalized mHealth-supported Resistance Training and Education for Children and Adolescents With Type 1 Diabetes: The Diactive-1 v2.0 Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07290868
- Acronym / sponsor ID
- Diactive-1v2 / AGH_Diactive1_2025
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- mHealth, Resistance training, Education, Handgrip strength
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Collaborators
- Universidad Pública de Navarra, University of Valencia, Fundación Instituto de Investigación Sanitaria de Navarra
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 18 Dec 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 Diactive-1 project aims to establish the Diactive-1 mobile application as a clinical tool for managing type 1 diabetes in children and adolescents in several hospitals from Spain. The successful implementation of the app in new healthcare centers nationwide represents a key step toward the development of a comprehensive and scalable program. This approach seeks not only to optimize current patient care but also to democratize access to an innovative, evidence-based intervention that supports daily diabetes management.
In this new phase, the project will integrate the application into routine clinical care for patients with type 1 diabetes through the use of a simple handgrip strength measurement. A dedicated web platform (www.diactive.es) is being developed to allow clinicians to enter basic patient data, including handgrip strength, sex, and email address. Based on this information, the system will automatically generate a personalized download link for the Diactive-1 app, accompanied by tailored guidance and an initial fitness level classification (low, medium, or high) according to European reference values.
This process will define each user's baseline fitness level and facilitate the use of Diactive-1 as an integrated and individualized disease management tool. The ultimate goal is to strengthen clinical decision-making, improve patient engagement, and extend the benefits of digital health to a broader pediatric population living with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diactive-1 | Experimental | Device: Diactive-1The intervention in the experimental group will center around the use of a mobile application (i.e., device), namely the Diactive-1 app. |
| Waiting-list control group | No intervention | –This arm will not complete an intervention. Participants will be instructed to continue to follow their normal daily diabetes care plan (i.e., standard care). This group will be granted access to the app following the intervention. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosed with Type 1 Diabetes Mellitus (T1DM) for 6 months or longer (requiring >0.5 U/kg/day of insulin and having HbA1c >6%, i.e., not in the "honeymoon phase").
- Receiving multiple daily injection (MDI) therapy or insulin pump therapy (CSII).
- Signed informed consent authorizing legal participation in the research project (child/adolescent and parent(s)/legal guardian).
- Availability to participate in the study using an m-Health application (Diactive-1) designed for the programming of muscle-bone strengthening physical exercise.
- Understanding of Spanish.
Key exclusion criteria (3 listed)
- Comorbidities that limit the ability to engage in physical activity.
- Lack of internet access when using the application, whether due to Wi-Fi, mobile data, or international roaming issues.
- Absence of a mobile phone or tablet with an Android or iOS (Apple) operating system, or no family member willing to lend a device for each session using the application for study-related purposes.
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 |
|---|---|---|
| Diactive-1Participants will engage in a 12-week resistance exercise program with the goal of maintaining at least 3 sessions per week, with 3-6 exercises per session (≈13-33 minutes). Participants will be able to choose among three training formats, traditional resistance training, Tabata/high-intensity intervals, or circuit training, and may perform the sessions individually or in pairs, depending on preference and feasibility at the center. The training intervention will comprise 3-4 sets of 6-12 repetitions and will consist of a combination of exercises for the upper body, lower body, and core, using primarily the participants' own body weight. The load and intensity of the exercise will be adjusted according to the number of repetitions and the difficulty/progression of the selected exercises. A mobile application (Diactive-1) will be used to deliver, monitor, and record the sessions. | Device | Diactive-1 |
Primary outcome
Change in handgrip strength
Time frame: Baseline and 12 weeks
Handgrip strength measured in kilograms using the Takei III Smedley Type Digital Dynamometer
23 secondary outcomes
Change in daily insulin dose requirement
Time frame: Baseline and 12 weeks
Change in glycated hemoglobin
Time frame: Baseline and 12 weeks
Number of participants with good glycemic control
Time frame: Baseline and 12 weeks
Change in time in range
Time frame: Baseline and 12 weeks
Change in time below range
Time frame: Baseline and 12 weeks
Change in time above range
Time frame: Baseline and 12 weeks
Change in glycemic variability
Time frame: Baseline and 12 weeks
Change in compliance with 24-hour movement behaviors
Time frame: Baseline and 12 weeks
Change in self-reported physical activity
Time frame: Baseline and 12 weeks
Change in self-reported physical fitness
Time frame: Baseline and 12 weeks
Change in sleep duration
Time frame: Baseline and 12 weeks
Change in physical literacy
Time frame: Baseline and 12 weeks
Change in physical activity barriers
Time frame: Baseline and 12 weeks
Adherence to the Mediterranean Diet
Time frame: Baseline and 12 weeks
Change in disordered eating
Time frame: Baseline and 12 weeks
Change in subjective well-being
Time frame: Baseline and 12 weeks
Change in Health-Related Quality of Life
Time frame: Baseline and 12 weeks
Change in Health-Related Quality of Life in the context of a chronic illness
Time frame: Baseline 12 weeks
Change in microalbuminuria
Time frame: Baseline and 12 weeks
Change in retinal findings
Time frame: Baseline and 12 weeks
Change in body mass index
Time frame: Baseline and 12 weeks
App usability: user
Time frame: 12 weeks
App usability: expert evaluation
Time frame: 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 9 Oct 2026.
- Derived from this study: PubMed 42666156Sanchez-Arlegui A, Munoz-Pardeza J, Hormazabal-Aguayo I, Abio-Abero S, Bertholt-Zuber ML, Alonso-Rubio P, Burillo-Sanchez E, Chueca-Guindulain MJ, Cifuentes-Zamalloa C, Congost-Marin S, Diez-Lopez I, Ferrer-Lozano M, Garcia-Navas P, Gonzalez-Garcia LG, Huidobro-Fernandez B, Lalaguna-Mallada P, Llorente-Cereza MT, Maeso-Mendez S, Riano-Galan I, Ruiz-Del Campo M, Salcedo Fresneda O, Vara-Callau M, Vela-Desojo A, Ezzatvar Y, Garcia-Hermoso A. Scale-up of the Diactive-1 mHealth program integrating tailored resistance training as an educational strategy for self-management in children and adolescents with type 1 diabetes: protocol for an 11-hospital multicenter randomized controlled trial. Front Endocrinol (Lausanne). 2026 Aug 14;17:1913568. doi: 10.3389/fendo.2026.1913568. eCollection 2026.
- 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?
A study testing Diactive-1 in people with Type 1 Diabetes (T1D), run by Fundacion Miguel Servet 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. 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?
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?
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?
Change in handgrip strength (time frame: Baseline and 12 weeks). 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 NCT07290868, 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 9 Oct 2026.