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Type 1 DiabetesDiactive-1NCT06048757

Mobile Application-delivered Resistance Program for Children and Adolescents With Type 1 Diabetes (Diactive-1)

A study testing Diactive-1 application in people with Type 1 Diabetes, run by Fundacion Miguel Servet at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project involves a two-arm randomized controlled trial (RCT) designed to assess the feasibility, acceptability, and preliminary efficacy of a mobile application aimed at prescribing resistance training for children and adolescents with type 1 diabetes (Diactive-1). Read more about this study

Who is it for?
Ages 8 to 18 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Diactive-1 application
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
2 sitesSpain
Study dates
20 Aug 2023to 1 Oct 2024
Phase
Interventional
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 8 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Aged 8-18 years old
  • At least 6 months post-diagnosis for type 1 diabetes
  • Ability to complete measures and intervention program in Spanish
  • Access to broadband or cellular internet
  • Patients who signed the informed consent form prior to participation; for minors, a legal representative must provide consent and sign the informed consent form.

Who cannot join

  • Any comorbidity limiting the capacity to participate in physical activity or inadequate understanding of the Spanish language.
  • Participants will be excluded if they don't have access to the internet, lack a smartphone or tablet, or are unable to use the application.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Fundación Miguel Servet/ Navarrabiomed

    Pamplona, Navarre, 31008

  • Paediatric Endocrinology Unit at Hospital Universitario de Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

About this study

Official title: Effectiveness of the Mobile Application-delivered Resistance Program for Children and Adolescents With Type 1 Diabetes (Diactive-1) on Insulin Requirements: Protocol for a Randomized Controlled Trial

This project involves a two-arm randomized controlled trial (RCT) designed to assess the feasibility, acceptability, and preliminary efficacy of a mobile application aimed at prescribing resistance training for children and adolescents with type 1 diabetes (Diactive-1). The program will span 24 weeks, with a minimum weekly frequency of 3 sessions. The researchers aim to recruit 52 participants but will enroll additional participants to account for potential withdrawals and ensure compliance with the desired sample size. The primary objective of the study is to evaluate the impact of the Diactive-1 mobile application on insulin requirements in children and adolescents with Type 1 Diabetes. Additionally, the researchers will investigate the effects of the Diactive-1 program on secondary parameters such as glycemic control, cardiometabolic indicators, physical fitness, and daily physical activity, among others. The hypothesis posits that personalized training through a mobile application, primarily focusing on muscular strength, will effectively reduce the daily insulin dosage in children and adolescents with type 1 diabetes.

Read the detailed description

The primary objective of this study is to evaluate the effectiveness of the Diactive-1 mobile application, which offers personalized resistance training, in reducing daily insulin requirements among children and adolescents with type 1 diabetes.

To achieve this objective, researchers will conduct a 24 weeks randomized controlled trial involving at least 52 participants diagnosed with type 1 diabetes. The study will consist of two groups: an experimental group utilizing the Diactive-1 application and a control group receiving standard treatment. Participant allocation to either group will be determined through central randomization.

The Diactive-1 intervention encompasses several key features, including: (i) tailoring exercises based on initial physical fitness levels; (ii) adjusting the previous exercise to the glucose level measured through an interstitial glucose monitor or entered manually before the training session; (iii) monitoring heart rate during exercise; (iv) providing the flexibility to train with or without equipment, individually or with a partner; (v) dispensing diabetes management advice before and after each training session; and (vi) adapting training progressions based on session adherence. A face-to-face session will be conducted before commencing the intervention to ensure that participants are familiar with the fundamental movements, thus reducing the risk of potential muscle injuries.

Conditions
Type 1 Diabetes
Being tested
Diactive-1 application
Keywords
mHealth, Resistance exercise, Insulin sensitivity, Glycemic control
Medical subject headings
Diabetes Mellitus, Type 1, Insulin Resistance

What participants receive

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

  • Diactive-1 applicationDevice

    Participants will engage in 24 weeks resistance exercise program with goal of maintaining at least 3 sessions per week with 4-5 exercises per session (13-33 minutes). The training intervention will comprise 3-4 sets of 6-12 repetitions and will consist of a combination of exercises for the upper and lower body and the core, utilizing the participants' body weight as the primary resistance or auxiliary materials such as elastic bands and a water-fillable kettlebell. The load and intensity of the exercise will be based on the number of repetitions, the resistance of the elastic bands and/or the weight of the aquaball, as well as the difficulty of the exercises. A mobile application known as Diactive-1 will be utilized.

Study groups in NCT06048757
Study groupRoleWhat they receive
Experimental app intervention groupExperimentalThe 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 application
Waiting-list control groupNo interventionThis 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.

  1. 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 9 days prior to the intervention, at 12 weeks, and after the intervention.

    Measured: Baseline, 12 and 24 weeks

Secondary outcomes (42)

  1. Change in glycated hemoglobin

    Glycated hemoglobin (measured in percent)

    Measured: Baseline and 24 weeks

  2. Number of participants with good glycemic control

    Number of participants with a glycated hemoglobin level lower than 7%

    Measured: Baseline and 24 weeks

  3. 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 24 weeks

  4. 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 24 weeks

  5. 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 24 weeks

  6. 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 24 weeks

  7. 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 GENEActive accelerometers and self-reported questionnaires

    Measured: Baseline and 24 weeks

  8. Change in physical activity

    Physical activity will be estimated using the GENEActive triaxial accelerometer (ActivInsights) and measured in minutes per day

    Measured: Baseline, 12 and 24 weeks

  9. 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 24 weeks

  10. Change in sedentary behaviors

    Sedentary behaviors will be self-reported using the Youth Leisure-Time Sedentary Behavior Questionnaire. Total daily sedentary screen time will be calculated by summing the durations of daily screen time activities. Furthermore, total screen time for both weekdays and weekends will be calculated in minutes per day

    Measured: Baseline and 24 weeks

  11. Change in sleep duration

    Sleep duration will be determined by recording the number of hours slept each day in a 9-day diary

    Measured: Baseline and 24 weeks

  12. Change in sleep quality

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index questionnaire, which evaluates seven established aspects of sleep quality: subjective sleep quality, time taken to fall asleep, duration of sleep, sleep efficiency, sleep disturbances (such as nightmares, pain, or feeling too hot or cold), use of sleep medication, and daytime dysfunction. Each question is scored on a scale from 0 to 3, with higher scores indicating more pronounced sleep disturbances.

    Measured: Baseline and 24 weeks

  13. Change in blood pressure

    Systolic and diastolic blood pressure will be measured in mmHg using a blood pressure monitor

    Measured: Baseline and 24 weeks

  14. Change in cardio-ankle vascular index (CAVI)

    Measuring Cardio-Ankle Vascular Index (measured in percent) by VaSera VS 2000 (Fukuda Denshi, Japan)

    Measured: Baseline and 24 weeks

  15. Change in pulse wave velocity

    Measuring pulse wave velocity (m/seg) by VaSera VS 2000 (Fukuda Denshi, Japan)

    Measured: Baseline and 24 weeks

  16. Change in heart rate variability

    The heart rate will be recorded by a heart rate monitor in a beat-by-beat basis.

    Measured: Baseline and 24 weeks

  17. 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 24 weeks

  18. 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). This questionnaire consists of 12 questions about how a patient has felt in the last four weeks, with responses rated on a 5-point Likert scale from 1 (Never) to 5 (Always)

    Measured: Baseline and 24 weeks

  19. 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). This is a generic 10-item unidimensional instrument that assesses the functional, mental, and social aspects of well-being in children and adolescents. Each item will offer five response categories, ranging from 'never' to 'always' or from 'not at all' to 'extremely'

    Measured: Baseline and 24 weeks

  20. Change in subjective well-being

    Subjective well-being will be assessed using the 'Cuestionario Unico de Bienestar Escolar' (CUBE), which comprises five items evaluating different aspects of life satisfaction. All variables will be measured on a 10-point Likert scale ranging from 0 to 10 (0 = totally disagree, 10 = totally agree).

    Measured: Baseline and 24 weeks

  21. Change in cardiorespiratory fitness

    Measured with an incremental VO2 protocol on exercise bike by COSMED Quark CPET plus OMNIA (COSMED®, Rome, Italy) (measured in mL/kg/min and Metabolic Equivalents [METs])

    Measured: Baseline and 24 weeks

  22. Change in isometric strength

    Handgrip strength measured in kilograms using the Takei III Smedley Type Digital Dynamometer

    Measured: Baseline, 12 and 24 weeks

  23. Change in lower limb muscle dynamic strength

    Lower limb muscle strength (legs and hips) measured in kg using eGym® machines (GmbH in Munich, Germany)

    Measured: Baseline and 24 weeks

  24. Change in upper limb muscle dynamic strength

    Upper limb muscle strength (chest and arms) measured in kg using eGym® machines (GmbH in Munich, Germany)

    Measured: Baseline and 24 weeks

  25. Change in lower limb muscle power strength

    Lower limb muscle power (legs and hips) measured in watts using eGym® machines (GmbH in Munich, Germany)

    Measured: Baseline and 24 weeks

  26. Change in upper limb muscle power strength

    Upper limb muscle power (chest and arms) measured in watts using eGym® machines (GmbH in Munich, Germany)

    Measured: Baseline and 24 weeks

  27. 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 24 weeks

  28. 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 24 weeks

  29. Change in dietary behavior

    Self-reported food intake will be assessed using a food-frequency questionnaire (FFQ). The daily consumption of food and beverages will be categorized into 12 groups: dairy, meat, fish, eggs, vegetables, fruit, starch, legumes, nuts, sweets, soft drinks, and alcoholic drinks.

    Measured: Baseline and 24 weeks

  30. Change in body mass index

    Weight and height will be combined to report body mass index in kg/m^2

    Measured: Baseline, 12 and 24 weeks

  31. Change in fat mass (percentage)

    Fat mass will be measured using a dual-energy X-ray absorptiometer (DXA) and expressed as a percentage.

    Measured: Baseline, 12 and 24 weeks

  32. Change in fat mass (in kilograms)

    Fat mass will be measured using a dual-energy X-ray absorptiometer (DXA) and expressed in kilograms.

    Measured: Baseline, 12 and 24 weeks

  33. Change in lean mass

    Fat mass in kilograms will be measured using a dual-energy X-ray absorptiometer (DXA)

    Measured: Baseline, 12 and 24 weeks

  34. Change in subcutaneos adiposity

    Subcutaneos adiposity in cm^3 will be measured using a dual-energy X-ray absorptiometer (DXA)

    Measured: Baseline, 12 and 24 weeks

  35. Change in visceral adiposity

    Visceral adiposity in cm^3 will be measured using a dual-energy X-ray absorptiometer (DXA)

    Measured: Baseline, 12 and 24 weeks

  36. Change in bone mineral content

    Bone mineral content in grams will be measured using a dual-energy X-ray absorptiometer (DXA)

    Measured: Baseline, 12 and 24 weeks

  37. Change in bone mineral density

    Bone mineral density will be measured in grams/cm^2 using a dual-energy X-ray absorptiometer (DXA)

    Measured: Baseline, 12 and 24 weeks

  38. Change in blood lipids levels

    The following parameters will be evaluated: fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), and apolipoproteins A-I and B levels, measured in mg/dL.

    Measured: Baseline and 24 weeks

  39. Change in fasting glucose

    Fasting glucose will be measured in mg/dL.

    Measured: Baseline and 24 weeks

  40. Changes in liver enzymes

    The following parameters will be evaluated: alanine transaminase and aspartate aminotransferase.

    Measured: Baseline and 24 weeks

  41. Change in inadvertent hypoglycemia

    The perception of hypoglycemia will be assessed using the Clarke test, which comprises eight questions with various potential answers. A score greater than 3 indicates impaired awareness of hypoglycemia.

    Measured: Baseline and 24 weeks

  42. App usability

    The usability of the app will be evaluated using the Spanish Version of the User Version of the Mobile Application Rating Scale (uMARS). This scale provides a comprehensive and objective measure of app usability and consists of 20 items. Each item is rated on a 5-point scale, ranging from 1 (inadequate) to 5 (excellent).

    Measured: 24 weeks

Timeline

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

  1. First posted21 Sep 2023
  2. Study start20 Aug 2023
  3. Primary completion1 Mar 2024
  4. Study completion1 Oct 2024

Resources

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
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06048757
Sponsor's protocol ID
AGH_Diactive1_2023
Acronym
Diactive-1
Status last verified
Dec 2025
First submitted
28 Aug 2023
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Munoz-Pardeza J, Lopez-Gil JF, Hormazabal-Aguayo I, Izquierdo M, Agostinis-Sobrinho C, Ezzatvar Y, Garcia-Hermoso A. Effects of Diactive-1-Supported Progressive Resistance Training on Body Composition in Youth With Type 1 Diabetes. J Cachexia Sarcopenia Muscle. 2026 Apr;17(2):e70257. doi: 10.1002/jcsm.70257.

    PubMed 41854192

  • Hormazabal-Aguayo I, Munoz-Pardeza J, Lopez-Gil JF, Huerta-Uribe N, Chueca-Guindulain MJ, Berrade-Zubiri S, Burillo Sanchez E, Izquierdo M, Ezzatvar Y, Garcia-Hermoso A. Comprehensive management of children and adolescents with type 1 diabetes mellitus through personalized physical exercise and education using an mHealth system: The Diactive-1 study protocol. Front Endocrinol (Lausanne). 2024 Feb 6;15:1354734. doi: 10.3389/fendo.2024.1354734. eCollection 2024.

    PubMed 38379866

Questions about this trial

What is this clinical trial studying?

A study testing Diactive-1 application in people with Type 1 Diabetes, run by Fundacion Miguel Servet 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 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: finished, as of the sponsor's last update on 17 Dec 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?

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?

Change in daily insulin dose requirement (time frame: Baseline, 12 and 24 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 NCT06048757, which also lists 2 linked publications.

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 17 Dec 2025.

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