Home › Trials › NCT06704672

Evaluating the Accu-Chek SmartGuide CGM for Diabetes Management

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

NA · Hoffmann-La Roche · NCT06704672

This study is testing if the Accu-Chek SmartGuide continuous glucose monitor can help adults with Type 1 or insulin-dependent Type 2 diabetes manage their blood sugar levels better than traditional self-monitoring methods.

Quick facts

PhaseNA
Study typeInterventional
Enrollment270 (estimated)
Ages18 Years and up
SexAll
SponsorHoffmann-La Roche (industry)
Locations16 sites (Gdansk and 15 other locations)
Trial IDNCT06704672 on ClinicalTrials.gov

What this trial studies

This clinical study is designed to assess the effectiveness of the Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution in improving time in range (TIR) for blood glucose levels in adults with Type 1 or insulin-dependent Type 2 diabetes. Participants will be randomly assigned to either use the CGM solution or continue with self-monitoring of blood glucose (SMBG). The study aims to determine if the CGM can provide better control of blood glucose levels compared to traditional monitoring methods. It involves multiple centers and focuses on individuals who have been managing their diabetes with multiple daily injections for at least six months.

Who should consider this trial

Good fit: Ideal candidates include adults with Type 1 or insulin-dependent Type 2 diabetes who have been on a multiple daily injection regimen for at least six months and are currently performing self-monitoring of blood glucose.

Not a fit: Patients with untreated adrenal or thyroid insufficiency, severe visual impairment, or significant renal impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved blood glucose management for patients with diabetes, enhancing their overall health and quality of life.

How similar studies have performed: Other studies have shown positive outcomes with continuous glucose monitoring systems, suggesting that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Gdansk and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.