Type 1 Diabetes MellitusNCT06704672
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
A study testing Accu-Chek SmartGuide CGM Solution, Accu-Chek SmartGuide Sensor and Blinded Apps and SMBG Device in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Hoffmann-La Roche at 20 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- What is being tested?
- Accu-Chek SmartGuide CGM Solution, Accu-Chek SmartGuide Sensor and Blinded Apps and SMBG Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 14 Apr 2025to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
20 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Study ID Reference: DC000129 Roche Diabetes Care Poland and Turkey contact
20 sites in 2 countries
Poland10 sites, 10 recruiting
- Recruiting
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
- Recruiting
Diabetes Technology Center, Jagiellonian University Medical College
Krakow, 31-501
- Recruiting
NZOZ Neuromed
Kraśnik, 23-204
- Recruiting
NZOZ Neuromed
Lublin, 20-064
- Recruiting
Institute of Rural Health
Lublin, 20-090
- Recruiting
KO-MED Centra Kliniczne Lublin II
Lublin, 30-362
- Recruiting
BioResearch Group Sp. z o. o.
Nadarzyn, 05-830
- Recruiting
Nbr Polska
Warsaw, 00-710
- Recruiting
Clinic of Internal Diseases, Endocrinology and Diabetology State Medical Institute MSWiA
Warsaw, 02-507
- Recruiting
ETG Warszawa
Warsaw, 02-677
Turkey (Türkiye)10 sites, 9 recruiting
- Recruiting
Baskent University Department of Endocrinology and Metabolism
Adana, 01240
- Recruiting
Bakırköy Sadi Konuk Training and Research Hospital
Bakirkoy Istanbul, 34147
- Withdrawn
Başakşehir Çam and Sakura City Hospital
Basaksehir / Istanbul, 24480
- Recruiting
Koç University Hospital
Istanbul, 34010
- Recruiting
Cerrahpasa Medical School Department of Endocrinology
Istanbul, 34303
- Recruiting
Medical Faculty of Istanbul University, Division of Endocrinology and Metabolism
Istanbul, 34303
- Recruiting
Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi
Istanbul, 34369
- Recruiting
Göztepe Prof. Dr. Süleyman Yalçın City Hospital
Istanbul, 34722
- Recruiting
Medeniyet University Hospital - İST (Prof. Dr. Süleyman Yalçın City Hospital, Internal Diseases)
Istanbul, 34722
- Recruiting
Ümraniye Training and Research Hospital
Ümraniye / İstanbul, 34764
About this study
Official title: 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).
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Being tested
- Accu-Chek SmartGuide CGM Solution, Accu-Chek SmartGuide Sensor and Blinded Apps, SMBG Device
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accu-Chek SmartGuide CGM SolutionDevice
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 AppsDevice
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 DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Accu-Chek SmartGuide CGM Solution | Experimental | Not described Receives: Device: Accu-Chek SmartGuide CGM Solution |
| Group B: Self-Monitoring of Blood Glucose (SMBG) | Other | Not described Receives: Device: Accu-Chek SmartGuide Sensor and Blinded Apps; Device: SMBG Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline Period (Weeks 1 and 2) and Assessment Period A (Weeks 5 and 6)
Secondary outcomes (21)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
A level 1 hypoglycemia event is defined as a blood glucose concentration of ≥54 to <70 mg/dL for at least 15 minutes.
Measured: 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
A level 2 hypoglycemia event is defined as a blood glucose concentration of <54 mg/dL for at least 15 minutes.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (Week 1 Day 1), Week 15 Day 1, and Week 27 Day 1
Average Daily Insulin Dose
Measured: Baseline (Week 1), Weeks 5, 13, and 25
Average Number of Daily Insulin Boluses Injected
Measured: Baseline (Week 1), Weeks 5, 13, and 25
Average Daily Amount of Carbohydrates Consumed
Measured: Baseline (Week 1), Weeks 5, 13, and 25
Hypoglycemia Fear Survey-II (HFS-II) Score at Specified Timepoints
Measured: 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
Measured: Baseline (Week 1 Day 1), Week 15 Day 1, and Week 27 Day 1
Ecological Momentary Assessment (EMA) Questionnaire Score at Specified Timepoints
Measured: 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)
Measured: Week 27 Day 1
Number of Healthcare Providers (HCP) by Their Responses to the Roche Diabetes Care HCP Accu-Chek Care Questionnaire
Measured: Week 27 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start14 Apr 2025
- Primary completion15 Nov 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Diabetes Care
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704672
- Sponsor's protocol ID
- DC000129
- Status last verified
- Oct 2026
- First submitted
- 22 Nov 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06704672
- Acronym / sponsor ID
- DC000129
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Roche Diabetes Care
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Accu-Chek SmartGuide CGM Solution | Experimental | Device: Accu-Chek SmartGuide CGM Solution |
| Group B: Self-Monitoring of Blood Glucose (SMBG) | Other | Device: Accu-Chek SmartGuide Sensor and Blinded Apps, Device: SMBG Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accu-Chek SmartGuide CGM SolutionThe 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. | Device | Group A: Accu-Chek SmartGuide CGM Solution |
| Accu-Chek SmartGuide Sensor and Blinded AppsThe 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 | Group B: Self-Monitoring of Blood Glucose (SMBG) |
| SMBG DeviceWith 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. | Device | Group B: Self-Monitoring of Blood Glucose (SMBG) |
Primary outcome
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)
21 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Average HbA1c Values from the Central Laboratory
Time frame: 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
Average Number of Daily Insulin Boluses Injected
Time frame: Baseline (Week 1), Weeks 5, 13, and 25
Average Daily Amount of Carbohydrates Consumed
Time frame: 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
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
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)
Number of Participants by Their Responses to the Roche Diabetes Care SmartGuide Usability Questionnaire (Group A Only)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study ID Reference: DC000129 Roche Diabetes Care Poland and Turkey contact
Clinical Trials study director
Hoffmann-La Roche
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accu-Chek SmartGuide CGM Solution, Accu-Chek SmartGuide Sensor and Blinded Apps and SMBG Device in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Hoffmann-La Roche at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Poland, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study ID Reference: DC000129 Roche Diabetes Care Poland and Turkey (+48 22 481 55 00; 08002113636, polska.diabetologia@roche.com; diyabetevi.turkey@roche.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.