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Can a smartphone app replace the gym for diabetes control?

NCT ID NCT07685080

Disease control Sponsor: Escuela Universitaria de Osuna Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study compares two 20-week exercise programs for adults aged 30-65 with both type 2 diabetes and obesity. One group attends supervised, in-person sessions twice a week, while another follows the same plan through a mobile app. A third group receives standard medical care only. All participants wear a Fitbit to track activity. The goal is to see if app-guided exercise can improve blood sugar, body composition, and quality of life as effectively as supervised training, potentially offering a more accessible option for long-term disease management.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
supervised and unsupervised mHealth-based exercise interventions
What this could lead to
If successful, this could show that app-guided exercise is as effective as in-person training for managing type 2 diabetes and obesity, offering a scalable, low-cost option for primary care.
What could go wrong
This is a relatively small, single-center trial. The 20-week program may not be long enough to see lasting changes, and adherence to unsupervised exercise could be low, limiting the results.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 126 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosed with both type 2 diabetes mellitus and obesity * Aged between 30 and 65 years * Body Mass Index (BMI) between 30 and 40 kg/m² * Glycated hemoglobin (HbA1c) greater than 6.5% (48 mmol/mol) * Fasting plasma or capillary blood glucose equal to or greater than 126 mg/dL (7.0 mmol/L) * Willing and able to provide informed consent to participate in the study * Available and willing to commit to a 20-week intervention period * Able and willing to use a smartphone and receive text messages * Able and willing to use a wearable device (smartwatch) and its associated mobile application Exclusion Criteria: * Presence of any obesity-related comorbidity requiring clinical referral, including eating disorders, pseudotumor cerebri, sleep apnea, hypoventilation syndrome, or orthopedic problems that limit physical activity * Presence of psychiatric or medical conditions that would prevent compliance with the study protocol * History of a cardiovascular event (myocardial infarction, stroke, heart failure episode, or revascularization procedure) in the past 6 months * Presence of any medical condition that contraindicates participation in the proposed physical activity program * Current use of insulin therapy * Presence of orthopedic or other physical limitations that may interfere with the ability to exercise safely * Currently undergoing treatment for a malignant tumor (other than non-melanoma skin cancer) * Currently receiving treatment for, or diagnosed with, an eating disorder * Planned bariatric or weight-loss surgery (e.g., liposuction, gastric band, gastric bypass) within the next 5 months * Currently pregnant, given birth in the last 6 months, breastfeeding in the last 3 months, or actively planning a pregnancy in the next 5 months * Currently enrolled in, or planning to enroll in, a weight loss program during the study period * Lost more than 5 kilograms of body weight in the past 3 months

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Conditions

The condition(s) this trial relates to.

Insulin Resistance Motor Activity Obesity obesity disorder Sedentary Behavior type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 2 Insulin resistance Mhealth Obesity Physical exercise Primary care Sedentary behaviors Wearable devices

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • José Manuel Jurado Castro

    Osuna, Sevilla, 41640, Spain

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