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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

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT06704672

Registry updated: 2026-09-28

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Description

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).

Interventions

Accu-Chek SmartGuide CGM Solution (Device)
The Accu-Chek SmartGuide CGM solution is used for real-time continuous glucose monitoring (CGM) in the interstitial fluid. It consists of the Accu-Chek SmartGuide device and two smartphone applications (apps): the Accu-Chek SmartGuide app and the Accu-Chek SmartGuide Predict app. The Accu-Chek SmartGuide device contains a CGM sensor pre-assembled in a sensor applicator. It has connectivity to the smartphone that is running the Accu-Chek apps. The Accu-Chek SmartGuide app is the primary display of the real-time glucose values. The Accu-Chek SmartGuide Predict app is an information management tool that further visualizes and analyzes diabetes data from the Accu-Chek SmartGuide device.
Accu-Chek SmartGuide Sensor and Blinded Apps (Device)
The participants in the SMBG control group will wear a SmartGuide sensor with blinded SmartGuide apps intermittently, i.e., during the assessment periods. It is not possible to read out the glucose data from the blinded app, hence neither the SmartGuide app nor the SmartGuide Predict functionalities can be accessed by the participants in this group.
SMBG Device (Device)
With the SmartGuide apps in blinded mode, participants in the SMBG control group will continue using their own SMBG device or they may use the Accu-Chek Instant meter that will be provided for calibration of the SmartGuide device.

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

Conditions

Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus

Locations

Centrum Badań Klinicznych PI-House sp. z o.o. — Gdansk, Poland
Diabetes Technology Center, Jagiellonian University Medical College — Krakow, Poland
NZOZ Neuromed — Kraśnik, Poland
NZOZ Neuromed — Lublin, Poland
Institute of Rural Health — Lublin, Poland
KO-MED Centra Kliniczne Lublin II — Lublin, Poland
BioResearch Group Sp. z o. o. — Nadarzyn, Poland
Nbr Polska — Warsaw, Poland
Clinic of Internal Diseases, Endocrinology and Diabetology State Medical Institute MSWiA — Warsaw, Poland
ETG Warszawa — Warsaw, Poland
Baskent University Department of Endocrinology and Metabolism — Adana, Turkey (Türkiye)
Bakırköy Sadi Konuk Training and Research Hospital — Bakirkoy Istanbul, Turkey (Türkiye)
Koç University Hospital — Istanbul, Turkey (Türkiye)
Cerrahpasa Medical School Department of Endocrinology — Istanbul, Turkey (Türkiye)
Medical Faculty of Istanbul University, Division of Endocrinology and Metabolism — Istanbul, Turkey (Türkiye)
Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi — Istanbul, Turkey (Türkiye)
Göztepe Prof. Dr. Süleyman Yalçın City Hospital — Istanbul, Turkey (Türkiye)
Medeniyet University Hospital - İST (Prof. Dr. Süleyman Yalçın City Hospital, Internal Diseases) — Istanbul, Turkey (Türkiye)
Ümraniye Training and Research Hospital — Ümraniye / İstanbul, Turkey (Türkiye)

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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