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

NCT06704672 | Recruiting

• 1 other identifier: DC000129
• Study Type: interventional
• Target: 270
• Locations: 2 countries
• Sites: 16

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 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

  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)

Study Arms (2)

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

Interventions

Accu-Chek SmartGuide CGM Solution DEVICE

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.

Group A: Accu-Chek SmartGuide CGM Solution

Accu-Chek SmartGuide Sensor and Blinded Apps DEVICE

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.

Group B: Self-Monitoring of Blood Glucose (SMBG)

SMBG Device 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.

Group B: Self-Monitoring of Blood Glucose (SMBG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roche Diabetes Care: collaborator
• Hoffmann-La Roche: lead

Study Sites (16)

Centrum Badań Klinicznych PI-House sp. z o.o.

Gdansk, 80-546, Poland

RECRUITING

Diabetes Technology Center, Jagiellonian University Medical College

Krakow, 31-501, Poland

RECRUITING

NZOZ Neuromed

Kraśnik, 23-204, Poland

RECRUITING

NZOZ Neuromed

Lublin, 20-064, Poland

RECRUITING

Institute of Rural Health

Lublin, 20-090, Poland

RECRUITING

KO-MED Centra Kliniczne Lublin II

Lublin, 30-362, Poland

RECRUITING

BioResearch Group Sp. z o. o.

Nadarzyn, 05-830, Poland

RECRUITING

Nbr Polska

Warsaw, 00-710, Poland

RECRUITING

Clinic of Internal Diseases, Endocrinology and Diabetology State Medical Institute MSWiA

Warsaw, 02-507, Poland

RECRUITING

ETG Warszawa

Warsaw, 02-677, Poland

RECRUITING

Baskent University Department of Endocrinology and Metabolism

Adana, 01240, Turkey (Türkiye)

RECRUITING

Bakırköy Sadi Konuk Training and Research Hospital

Bakirkoy Istanbul, 34147, Turkey (Türkiye)

RECRUITING

Koç University Hospital

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Cerrahpasa Medical School Department of Endocrinology

Istanbul, 34303, Turkey (Türkiye)

RECRUITING

Medeniyet University Hospital - İST (Prof. Dr. Süleyman Yalçın City Hospital, Internal Diseases)

Istanbul, 34722, Turkey (Türkiye)

RECRUITING

Ümraniye Training and Research Hospital

Ümraniye / İstanbul, 34764, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Study ID Reference: DC000129 Roche Diabetes Care Poland and Turkey

CONTACT

+48 22 481 55 00; 08002113636; polska.diabetologia@roche.com; diyabetevi.turkey@roche.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: April 14, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

PL (10); TU (6)