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
NCT ID: NCT06704672
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
270 participants
INTERVENTIONAL
2025-04-14
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes
NCT01237301
A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes
NCT00674986
Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG
NCT01820169
CGM Use in Adults With Type 2 Diabetes on Basal Insulin
NCT05944432
Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes
NCT05633628
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A: Accu-Chek SmartGuide CGM Solution
Accu-Chek SmartGuide CGM Solution
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.
Group B: Self-Monitoring of Blood Glucose (SMBG)
Accu-Chek SmartGuide Sensor and Blinded Apps
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Accu-Chek SmartGuide CGM Solution
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
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
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Roche Diabetes Care
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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)
Koç University Hospital
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Study ID Reference: DC000129 Roche Diabetes Care Poland and Turkey
Role: CONTACT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DC000129
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.