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Smartwatches and AI could predict diabetes complications in new study

NCT ID NCT07129148

Knowledge-focused Sponsor: Second Xiangya Hospital of Central South University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether wearable devices like continuous glucose monitors and smart bracelets, combined with smartphone apps, can help predict and prevent complications in people with type 2 diabetes. Researchers will enroll 6,000 adults and follow them for 3 months, using AI to analyze data from the wearables. The goal is to see if this technology can improve blood sugar control and reduce the risk of diabetes-related health problems.

What this could mean

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

Active substance
Wearable devices (CGM, smart bracelet) and smartphone mini-programs
What this could lead to
If successful, this could show that AI and wearable tech help predict and reduce diabetes complications, leading to better remote management tools.
What could go wrong
This is an early-stage observational study without a control group, so results may not prove cause and effect. The 3-month follow-up is short for seeing long-term benefits.

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 6,000 people

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

Started

Oct 2025

Expected to finish

Oct 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

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: 1. Confirmed diagnosis of Type 2 Diabetes; 2. Aged ≥ 18 years; 3. Able to accept the diabetes management model with AI-assisted management and wearable device monitoring; 4. Able to provide complete lifestyle records, including medical history, medication status, diet, exercise, etc.; 5. Fully understand the purpose, nature, and methods of the study, voluntarily participate in this study, accept a 3-month follow-up, and sign the informed consent form. Exclusion Criteria: 1. Having severe mental illness or language barriers; 2. Suffering from malignant tumors; 3. Pregnant or lactating women; 4. Suspected active infections (such as active pulmonary tuberculosis, pneumonia, etc.); 5. Severe hepatic and renal insufficiency (alanine transaminase and/or aspartate transaminase \> 3 times the upper limit of normal; estimated glomerular filtration rate \< 15 mL/min/1.73 m²); 6. A history of definite major adverse cardiovascular events and/or revascularization and/or intravenous thrombolysis and/or endovascular thrombectomy; 7. Uncontrolled hyperthyroidism or hypothyroidism, pituitary-adrenal dysfunction, or other endocrine diseases; 8. Alcoholism or drug addiction; 9. Receiving insulin therapy; 10. Unable to accept new comprehensive intervention technologies for various reasons (such as personal beliefs, economic factors, etc.).

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Conditions

The condition(s) this trial relates to.

Diabetes Complications type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus complications Diabetes mellitus 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

    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

  • Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, China

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