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Can a smart patch beat fingersticks for blood sugar control?

NCT ID NCT06704672

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 28, 2026 · Updated 5 times

Summary

This study compares a continuous glucose monitor (CGM) to standard fingerstick testing in 270 adults with type 1 or type 2 diabetes who use insulin injections. Participants wear the Accu-Chek SmartGuide sensor to track blood sugar levels continuously. The goal is to see if the CGM helps them spend more time in the target blood sugar range (70–180 mg/dL) than fingerstick testing alone.

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 270 people

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

Started

Apr 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Type 1 Diabetes mellitus (T1D) or Type 2 Diabetes mellitus (T2D) diagnosed at least 12 months prior to screening, using multiple daily injection (MDI) regime for at least six months prior to screening * Performing SMBG, no CGM/flash glucose monitoring (FGM) use during the last six months prior screening * HbA1c ≥8% and ≤10% based on analysis from a local laboratory Exclusion Criteria: * Untreated adrenal or thyroid insufficiency * Severe visual impairment * Significant renal impairment: eGFR \<30 ml/min within last one year * Serious acute or chronic concomitant disease or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject * Hematocrit greater than 10% below the lower limit of normal * Pregnancy (lack of negative pregnancy test - except in case of menopause, sterilization or hysterectomy - self-reported), planned pregnancy, or breast feeding * Allergic to the adhesive (glue or tape) * Skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) at the sensor application sites * Sickle cell disease, or hemoglobinopathy * Elective surgery planned that requires general anesthesia during study participation * Current or anticipated acute uses of glucocorticoids (oral, injectable, or intravenous) * Medical conditions that, per investigator determination, make it inappropriate or unsafe to target an HbA1c of \<7%. Conditions may include but are not limited to: heart failure, unstable cardiovascular disease, recent myocardial infarction, ventricular rhythm disturbances, recent transient ischemic attack or cerebrovascular accident, significant malignancy * Chronic use of opiates, opioids, morphinomimetics more than three times per week, which has not stopped at least 30 days prior to screening and any other medication interfering with the assessment of pain, as per investigator's discretion * Intake of hydroxyurea (hydroxycarbamide), levodopa, methyldopa, ascorbic acid, acetylsalicylic acid (≥300mg), which has not stopped at least 30 days prior to screening * Magnetic resonance tomography (MRT), computed tomography (CT), X-ray, radiofrequency ablation, high-frequency electrical heat or high intensity focused ultrasound planned during the course of the study * Planned flight or high-altitude hike (\>3000 m) during baseline and assessment periods * Shift-worker (night-shifts) * On or planning to start a diet intended for weight change * Currently abusing illicit and/or prescription drugs or alcohol as judged by the investigator * Any other physical or psychological disease or psychiatric disorder that could limit adherence to the required study tasks and interfere with the normal conduct of the study as judged by the investigator * Dependency (e.g., employee, co-worker or family member) on sponsor, investigator or companies active in the field of CGM (e.g. Dexcom, Abbott, Menarini, Medtronic) or their subsidiaries * Participation in another clinical study at the same time

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Conditions

The condition(s) this trial relates to.

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

    19 sites in 2 countries. 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

  • Bakırköy Sadi Konuk Training and Research Hospital

    RECRUITING

    Bakirkoy Istanbul, 34147, Turkey (Türkiye)

  • Baskent University Department of Endocrinology and Metabolism

    RECRUITING

    Adana, 01240, Turkey (Türkiye)

  • BioResearch Group Sp. z o. o.

    RECRUITING

    Nadarzyn, 05-830, Poland

  • Centrum Badań Klinicznych PI-House sp. z o.o.

    RECRUITING

    Gdansk, 80-546, Poland

  • Cerrahpasa Medical School Department of Endocrinology

    RECRUITING

    Istanbul, 34303, Turkey (Türkiye)

  • Clinic of Internal Diseases, Endocrinology and Diabetology State Medical Institute MSWiA

    RECRUITING

    Warsaw, 02-507, Poland

  • Diabetes Technology Center, Jagiellonian University Medical College

    RECRUITING

    Krakow, 31-501, Poland

  • ETG Warszawa

    RECRUITING

    Warsaw, 02-677, Poland

  • Göztepe Prof. Dr. Süleyman Yalçın City Hospital

    RECRUITING

    Istanbul, 34722, Turkey (Türkiye)

  • Institute of Rural Health

    RECRUITING

    Lublin, 20-090, Poland

  • KO-MED Centra Kliniczne Lublin II

    RECRUITING

    Lublin, 30-362, Poland

  • Koç University Hospital

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

  • Medeniyet University Hospital - İST (Prof. Dr. Süleyman Yalçın City Hospital, Internal Diseases)

    RECRUITING

    Istanbul, 34722, Turkey (Türkiye)

  • Medical Faculty of Istanbul University, Division of Endocrinology and Metabolism

    RECRUITING

    Istanbul, 34303, Turkey (Türkiye)

  • NZOZ Neuromed

    RECRUITING

    Kraśnik, 23-204, Poland

  • NZOZ Neuromed

    RECRUITING

    Lublin, 20-064, Poland

  • Nbr Polska

    RECRUITING

    Warsaw, 00-710, Poland

  • Ümraniye Training and Research Hospital

    RECRUITING

    Ümraniye / İstanbul, 34764, Turkey (Türkiye)

  • Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi

    RECRUITING

    Istanbul, 34369, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.