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

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: Recruiting
• Conditions: Type 2 Diabetes Mellitus; Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: Accu-Chek SmartGuide CGM Solution; Device: Accu-Chek SmartGuide Sensor and Blinded Apps; Device: SMBG Device

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study ID Reference: DC000129 Roche Diabetes Care Poland and Turkey; Phone Number: +48 22 481 55 00; 08002113636; Email: polska.diabetologia@roche.com; diyabetevi.turkey@roche.com

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
    • Koç 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
    • Ümraniye Training and Research Hospital

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	Baseline Period (Weeks 1 and 2) and Assessment Period A (Weeks 5 and 6)

Secondary Outcome Measures

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		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		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		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		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		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		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		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.	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.	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		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		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		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		Baseline (Week 1 Day 1), Week 15 Day 1, and Week 27 Day 1
Average Daily Insulin Dose		Baseline (Week 1), Weeks 5, 13, and 25
Average Number of Daily Insulin Boluses Injected		Baseline (Week 1), Weeks 5, 13, and 25
Average Daily Amount of Carbohydrates Consumed		Baseline (Week 1), Weeks 5, 13, and 25
Hypoglycemia Fear Survey-II (HFS-II) Score at Specified Timepoints		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		Baseline (Week 1 Day 1), Week 15 Day 1, and Week 27 Day 1
Ecological Momentary Assessment (EMA) Questionnaire Score at Specified Timepoints		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)		Week 27 Day 1
Number of Healthcare Providers (HCP) by Their Responses to the Roche Diabetes Care HCP Accu-Chek Care Questionnaire		Week 27 Day 1

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Roche Diabetes Care
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID 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