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NCT06704672From ClinicalTrials.govRecruiting

Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus

Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range of 70 - 180 mg/dl Compared to SMBG

  • Type 1 Diabetes Mellitus
  • Type 2 Diabetes Mellitus

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Hoffmann-La Roche
Enrolment target
270
Started
14 April 2025
Main results due
15 November 2026
Study sites
19
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

This is an open label, two-arm, randomized multi-center clinical device study in adult subjects with Type 1 diabetes (T1D) or insulin-dependent Type 2 diabetes (T2D) on a multiple daily injection (MDI) regime.

The goal of the study is to investigate the impact of the Accu-Chek SmartGuide CGM solution on the change in overall time in range (TIR) of blood glucose concentrations of 70-180 mg/dl compared with that using self-monitoring of blood glucose (SMBG).

Study sites(19)

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

    Gdansk, Poland

    Recruiting

  • Diabetes Technology Center, Jagiellonian University Medical College

    Krakow, Poland

    Recruiting

  • NZOZ Neuromed

    Kraśnik, Poland

    Recruiting

  • NZOZ Neuromed

    Lublin, Poland

    Recruiting

  • Institute of Rural Health

    Lublin, Poland

    Recruiting

  • KO-MED Centra Kliniczne Lublin II

    Lublin, Poland

    Recruiting

  • BioResearch Group Sp. z o. o.

    Nadarzyn, Poland

    Recruiting

  • Nbr Polska

    Warsaw, Poland

    Recruiting

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

    Warsaw, Poland

    Recruiting

  • ETG Warszawa

    Warsaw, Poland

    Recruiting

  • Baskent University Department of Endocrinology and Metabolism

    Adana, Turkey (Türkiye)

    Recruiting

  • Bakırköy Sadi Konuk Training and Research Hospital

    Bakirkoy Istanbul, Turkey (Türkiye)

    Recruiting

  • Koç University Hospital

    Istanbul, Turkey (Türkiye)

    Recruiting

  • Cerrahpasa Medical School Department of Endocrinology

    Istanbul, Turkey (Türkiye)

    Recruiting

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

    Istanbul, Turkey (Türkiye)

    Recruiting

  • Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi

    Istanbul, Turkey (Türkiye)

    Recruiting

  • Göztepe Prof. Dr. Süleyman Yalçın City Hospital

    Istanbul, Turkey (Türkiye)

    Recruiting

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

    Istanbul, Turkey (Türkiye)

    Recruiting

  • Ümraniye Training and Research Hospital

    Ümraniye / İstanbul, Turkey (Türkiye)

    Recruiting

Showing 19 of 19 sites. 19 of the 19 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06704672. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in R | Trialion