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

Launched by HOFFMANN-LA ROCHE · Nov 22, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to study how well the Accu-Chek SmartGuide Continuous Glucose Monitoring (CGM) solution helps people with Type 1 or insulin-dependent Type 2 diabetes manage their blood sugar levels compared to traditional self-monitoring methods. The main goal is to see if using this CGM technology can increase the amount of time that participants keep their blood sugar in a healthy range, which is between 70 and 180 mg/dL.

To participate in this study, individuals must be adults diagnosed with either Type 1 or Type 2 diabetes for at least a year and have been using multiple daily insulin injections for at least six months. They should also be checking their blood sugar with finger pricks and not using any continuous glucose monitoring devices in the last six months. Participants can expect to be part of a randomized study where they will either use the CGM or continue with their usual monitoring. This study is still recruiting participants, and it’s important to note that certain health conditions and medications may exclude someone from joining.

Gender

ALL

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