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

May 13, 2026 updated by: Hoffmann-La Roche

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
      • Gdansk, Poland, 80-546
        • Recruiting
        • Centrum Badan Klinicznych PI-House sp. z o.o.
      • Krakow, Poland, 31-501
        • Recruiting
        • Diabetes Technology Center, Jagiellonian University Medical College
      • Kraśnik, Poland, 23-204
        • Recruiting
        • NZOZ Neuromed
      • Lublin, Poland, 20-064
        • Recruiting
        • NZOZ Neuromed
      • Lublin, Poland, 30-362
        • Recruiting
        • KO-MED Centra Kliniczne Lublin II
      • Lublin, Poland, 20-090
        • Recruiting
        • Institute of Rural Health
      • Nadarzyn, Poland, 05-830
        • Recruiting
        • BioResearch Group Sp. z o. o.
      • Warsaw, Poland, 02-677
        • Recruiting
        • ETG Warszawa
      • Warsaw, Poland, 02-507
        • Recruiting
        • Clinic of Internal Diseases, Endocrinology and Diabetology State Medical Institute MSWiA
      • Warsaw, Poland, 00-710
        • Recruiting
        • NBR Polska
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01240
        • Recruiting
        • Baskent University Department of Endocrinology and Metabolism
      • Bakirkoy Istanbul, Turkey (Türkiye), 34147
        • Recruiting
        • Bakırköy Sadi Konuk Training and Research Hospital
      • Istanbul, Turkey (Türkiye), 34010
        • Recruiting
        • Koc University Hospital
      • Istanbul, Turkey (Türkiye), 34303
        • Recruiting
        • Cerrahpasa Medical School Department of Endocrinology
      • Istanbul, Turkey (Türkiye), 34722
        • Recruiting
        • Medeniyet University Hospital - İST (Prof. Dr. Süleyman Yalçın City Hospital, Internal Diseases)
      • Istanbul, Turkey (Türkiye), 34303
        • Recruiting
        • Medical Faculty of Istanbul University, Division of Endocrinology and Metabolism
      • Istanbul, Turkey (Türkiye), 34722
        • Recruiting
        • Göztepe Prof. Dr. Süleyman Yalçın City Hospital
      • Ümraniye / İstanbul, Turkey (Türkiye), 34764
        • Recruiting
        • Umraniye Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A: Accu-Chek SmartGuide CGM Solution
Device: 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.
Other: Group B: Self-Monitoring of Blood Glucose (SMBG)
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in the Percentage of Time in Range of a Blood Glucose Concentration of 70 to 180 mg/dL from the Baseline Period to Assessment Period A
Time Frame: Baseline Period (Weeks 1 and 2) and Assessment Period A (Weeks 5 and 6)
Baseline Period (Weeks 1 and 2) and Assessment Period A (Weeks 5 and 6)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the Percentage of Time in Range of a Blood Glucose Concentration of 70 to 180 mg/dL from the Baseline Period to Assessment Period B
Time Frame: Baseline Period (Weeks 1 and 2) and Assessment Period B (Weeks 13 and 14)
Baseline Period (Weeks 1 and 2) and Assessment Period B (Weeks 13 and 14)
Change in the Percentage of Time in Range of a Blood Glucose Concentration of 70 to 180 mg/dL from the Baseline Period to Assessment Period C
Time Frame: Baseline Period (Weeks 1 and 2) and Assessment Period C (Weeks 25 and 26)
Baseline Period (Weeks 1 and 2) and Assessment Period C (Weeks 25 and 26)
Percentage of Time in Tight Range of a Blood Glucose Concentration of 70 to 140 mg/dL by Study Period
Time Frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Percentage of Time Above Range (Blood Glucose Concentration of >180 to ≤250 mg/dL) in Level 1 Hyperglycemia by Study Period
Time Frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Percentage of Time Above Range (Blood Glucose Concentration >250 mg/dL) in Level 2 Hyperglycemia by Study Period
Time Frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Percentage of Time Below Range (Blood Glucose Concentration of ≥54 to <70 mg/dL) in Level 1 Hypoglycemia by Study Period
Time Frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Percentage of Time Below Range (Blood Glucose Concentration <54 mg/dL) in Level 2 Hypoglycemia by Study Period
Time Frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Number of Level 1 Hypoglycemia Events by Study Period
Time Frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
A level 1 hypoglycemia event is defined as a blood glucose concentration of ≥54 to <70 mg/dL for at least 15 minutes.
Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Number of Level 2 Hypoglycemia Events by Study Period
Time Frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
A level 2 hypoglycemia event is defined as a blood glucose concentration of <54 mg/dL for at least 15 minutes.
Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Average Glucose Management Indicator, as an Estimate of HbA1c, by Study Period
Time Frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Average Blood Glucose Concentration by Study Period
Time Frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Average Glycemic Variability in Blood Glucose Concentration by Study Period
Time Frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Average HbA1c Values from the Central Laboratory
Time Frame: Baseline (Week 1 Day 1), Week 15 Day 1, and Week 27 Day 1
Baseline (Week 1 Day 1), Week 15 Day 1, and Week 27 Day 1
Average Daily Insulin Dose
Time Frame: Baseline (Week 1), Weeks 5, 13, and 25
Baseline (Week 1), Weeks 5, 13, and 25
Average Number of Daily Insulin Boluses Injected
Time Frame: Baseline (Week 1), Weeks 5, 13, and 25
Baseline (Week 1), Weeks 5, 13, and 25
Average Daily Amount of Carbohydrates Consumed
Time Frame: Baseline (Week 1), Weeks 5, 13, and 25
Baseline (Week 1), Weeks 5, 13, and 25
Hypoglycemia Fear Survey-II (HFS-II) Score at Specified Timepoints
Time Frame: Baseline (Week 1 Day 1), Week 15 Day 1, and Week 27 Day 1
Baseline (Week 1 Day 1), Week 15 Day 1, and Week 27 Day 1
Diabetes Distress Scale 17 (DDS-17) Questionnaire Score at Specified Timepoints
Time Frame: Baseline (Week 1 Day 1), Week 15 Day 1, and Week 27 Day 1
Baseline (Week 1 Day 1), Week 15 Day 1, and Week 27 Day 1
Ecological Momentary Assessment (EMA) Questionnaire Score at Specified Timepoints
Time Frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Number of Participants by Their Responses to the Roche Diabetes Care SmartGuide Usability Questionnaire (Group A Only)
Time Frame: Week 27 Day 1
Week 27 Day 1
Number of Healthcare Providers (HCP) by Their Responses to the Roche Diabetes Care HCP Accu-Chek Care Questionnaire
Time Frame: Week 27 Day 1
Week 27 Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Diabetes Care

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DC000129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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