Could a wearable sensor transform early diabetes care?

NCT ID NCT07690163

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This trial compares two ways of monitoring blood sugar in adults recently diagnosed with type 2 diabetes (within the last 3 months). Half of the 80 participants use a real-time continuous glucose monitor (CGM) that provides constant feedback, while the other half use standard fingerstick testing. The study measures changes in HbA1c and other markers to see if the CGM leads to better blood sugar control and healthier habits.

What this could mean

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

Active substance
Continuous glucose monitoring (CGM) device
What this could lead to
If it works, this could show that using a continuous glucose monitor from the start helps people with new type 2 diabetes manage their blood sugar more effectively and stick to healthy habits.
What could go wrong
This is a small, early-stage trial with only 80 participants, so results may not apply to everyone. The device is already approved, but the study is testing whether it is better than standard care, which may not be proven.

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 80 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Mar 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: * Age of 18 years and older. * Newly diagnosed Type 2 Diabetes Mellitus according to ADA (American Diabetes Association) criteria (Fasting Plasma Glucose ≥ 7.0 mmol/L, or 2-hour Post-Prandial Glucose ≥ 11.1 mmol/L during OGTT, or HbA1c ≥6.5%). * Time since the initial diagnosis of T2D must not exceed 3 months ( less 90 days) at the time of screening. * HbA1c level between 6.5% and 9.5% (inclusive) at screening. * Patients may be lifestyle-controlled or receiving any stable non-insulin anti-diabetic therapy (including Metformin, SGLT2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, or Sulfonylureas) as monotherapy or combination therapy. * Ability to provide written informed consent and willingness to adhere to the study protocol and follow-up schedule. Exclusion Criteria: * Diagnosis or suspicion of Type 1 Diabetes, Latent Autoimmune Diabetes in Adults (LADA) (e.g., positive anti-GAD antibodies if tested), or secondary types of diabetes (e.g., pancreatic or drug-induced). * Any prior or current use of insulin therapy. * Severe microvascular or macrovascular complications (proliferative retinopathy, severe diabetic nephropathy with eGFR \< 45 mL/min/1.73m², diabetic foot ulcers, severe peripheral neuropathy). * Endocrine disorders (e.g., Itsenko-Cushing syndrome, acromegaly) that affect glycemia. * History of myocardial infarction, stroke, unstable angina, coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) within the past 6 months. * Active malignancy, decompensated heart failure (NYHA Class III or IV), or chronic infectious diseases. * Pregnant or breastfeeding women, or women of childbearing potential not using highly effective contraception. * Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant. * Participation in another clinical study within the last 3 months.

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Conditions

The condition(s) this trial relates to.

Insulin Resistance Obesity obesity disorder Overweight type 2 diabetes mellitus

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    3 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

  • Bogomolets National Medical University

    RECRUITING

    Kyiv, 01601, Ukraine

  • Bogomoletz Institute of Physiology

    ENROLLING_BY_INVITATION

    Kyiv, 01601, Ukraine

  • University Hospital of Bogomolets National Medical University

    RECRUITING

    Kyiv, 01601, Ukraine

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