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New app aims to help diabetes patients take control at home

NCT ID NCT07149610

Disease control Sponsor: Marche Region Regional Health Agency Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study tests whether a mobile health app can help people with type 2 diabetes better manage their condition. About 388 adults in Italy will use the app to track blood sugar, diet, and activity, and communicate with their care team. The goal is to see if app users have better blood sugar control compared to those receiving standard care.

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 388 people

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

Started

Oct 2025

Expected to finish

Dec 2026

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

18 years and older

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: * patients with T2DM (as confirmed by the physician's diagnosis); * belonging to one of the 13 Diabetes Centres (CADs) of the Marche region in Italy (Pesaro, Urbino, Fano, Senigallia, Jesi, Fabriano, IRCCS-INRCA, Azienda Ospedaliera Universitaria delle Marche, Civitanova Marche, Macerata, Fermo, San Benedetto del Tronto e Ascoli Piceno); * age \> = 18; * resident in the Marche region; * HbA1c \> 7 on most recent laboratory report within the last 3 months; * no changes in diabetes medication in the previous 6 months; * no prescription for any hypoglycaemic agent within the previous 4 weeks or taking a consistent dose of one or more oral hypoglycaemic agents for more than 12 weeks; * owning smartphone/mobile phone with an internet connection; * capable to consent; * fulfilling and signing the informed consent; * with self-reported competencies of communicating verbally in local language (corresponding to a level of Italian language knowledge =\>A2 of the CEFR levels). Exclusion Criteria: * acute medical problems: myocardial infarction or stroke within 6 months, difficulty in exercise and physical activity due to spinal disease (intervertebral disc prolapse, spinal stenosis, etc.), joint disease, or major surgery at the time of screening, painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility, advanced Parkinson's disease and/or neuromuscular disorders, advanced dementia, metastatic cancer, in long-term immunosuppressant therapy, significant visual or hearing impairment, uncontrolled hypertension or other serious conditions that restrict their participation in the study, severe/major depression and other relevant psychiatric disorders; * estimated glomerular filtration rate \< 30 mL/min/1.73 m2; * plan to receive surgery that could limit physical activity during the study period; * pregnant or breastfeeding; * participation in another studies; * lack of written informed consent.

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Conditions

The condition(s) this trial relates to.

Chronic Disease type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes type 2

How to take part

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

  1. The places running it

    11 sites. 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

  • Diabetic Center of Azienda Ospedaliero Universitaria delle Marche

    RECRUITING

    Ancona, Ancona, 60126, Italy

  • Diabetic Center of National Institute for the Care and Treatment of the Elderly (Istituto Nazionale di Ricovero e Cura per Anziani-INRCA)

    RECRUITING

    Ancona, Ancona, 60127, Italy

  • Diabetic Center of Territorial Healthcare Authority of Ancona province

    NOT_YET_RECRUITING

    Fabriano, Ancona, 60044, Italy

  • Diabetic Center of Territorial Healthcare Authority of Ancona province

    RECRUITING

    Iesi, Ancona, 60035, Italy

  • Diabetic Center of Territorial Healthcare Authority of Ascoli Piceno province

    NOT_YET_RECRUITING

    Ascoli Piceno, Ascoli Piceno, 63100, Italy

  • Diabetic Center of Territorial Healthcare Authority of Ascoli Piceno province

    RECRUITING

    San Benedetto del Tronto, Ascoli Piceno, 63074, Italy

  • Diabetic Center of Territorial Healthcare Authority of Fermo province

    RECRUITING

    Fermo, Fermo, 63900, Italy

  • Diabetic Center of Territorial Healthcare Authority of Macerata province

    RECRUITING

    Civitanova Marche, Macerata, 62012, Italy

  • Diabetic Center of Territorial Healthcare Authority of Macerata province

    RECRUITING

    Province of Macerata, Macerata, 62100, Italy

  • Diabetic Center of Territorial Healthcare Authority of Pesaro Urbino province

    RECRUITING

    Fano, Pesaro-Urbino, 61032, Italy

  • Diabetic Center of Territorial Healthcare Authority of Pesaro Urbino province

    RECRUITING

    Pesaro, Pesaro-urbino, 61122, Italy

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