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

Официальное название

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

Обзор

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).

Вмешательства

• Устройство 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 o
• Устройство 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.
• Устройство 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.

Первичные конечные точки

• 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 [Срок оценки: Baseline Period (Weeks 1 and 2) and Assessment Period A (Weeks 5 and 6)]

Вторичные конечные точки (12)

• 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Польша · 10 центров

• Centrum Badań Klinicznych PI-House sp. z o.o. — Gdansk
• Diabetes Technology Center, Jagiellonian University Medical College — Krakow
• NZOZ Neuromed — Kraśnik
• NZOZ Neuromed — Lublin
• Institute of Rural Health — Lublin
• KO-MED Centra Kliniczne Lublin II — Lublin
• BioResearch Group Sp. z o. o. — Nadarzyn
• Nbr Polska — Warsaw
• … и ещё 2 центра

Turkey (Türkiye) · 9 центров

• Baskent University Department of Endocrinology and Metabolism — Adana
• Bakırköy Sadi Konuk Training and Research Hospital — Bakirkoy Istanbul
• Koç University Hospital — Istanbul
• Cerrahpasa Medical School Department of Endocrinology — Istanbul
• Medical Faculty of Istanbul University, Division of Endocrinology and Metabolism — Istanbul
• Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi — Istanbul
• Göztepe Prof. Dr. Süleyman Yalçın City Hospital — Istanbul
• Medeniyet University Hospital - İST (Prof. Dr. Süleyman Yalçın City Hospital, Internal Dis — Istanbul
• … и ещё 1 центр

Идентификаторы

NCT: NCT06704672 · DC000129

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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