RecruitingNot ApplicableNCT06704672

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

Sponsor

Hoffmann-La Roche

Enrollment

270 participants

Start Date

Apr 14, 2025

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new continuous glucose monitoring (CGM) device called Accu-Chek SmartGuide — which tracks blood sugar levels throughout the day with a small sensor worn on the body — to traditional finger-prick blood glucose testing, to see if CGM helps people with diabetes spend more time with their blood sugar in a healthy range. **You may be eligible if...** - You have Type 1 or Type 2 diabetes diagnosed at least 12 months ago - You take insulin through multiple daily injections and have done so for at least 6 months - You currently test your blood sugar with finger-pricks and have not used a CGM or flash glucose monitor in the last 6 months - Your HbA1c (average blood sugar over 3 months) is between 8% and 10% **You may NOT be eligible if...** - You have severe kidney impairment, untreated thyroid or adrenal problems, or serious other health conditions - You are pregnant, planning to become pregnant, or breastfeeding - You have a skin condition or allergy that would prevent wearing a sensor - You have sickle cell disease or a hemoglobin disorder - You are planning elective surgery under general anesthesia during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAccu-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.

DEVICEAccu-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.

DEVICESMBG 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.

Locations(16)

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)

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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