CGM Experience, Preferences & Blood Glucose Parameters

Официальное название

Instara™-1 Dual Perspectives on Continuous Glucose Monitoring: Understanding Patient Experience and Healthcare Professional Preferences

Обзор

This is an open-label, prospective, multicenter observational study designed to evaluate the perceived benefits, device experience, preference, and glucose-related parameters associated with the Instara-1 Continuous Glucose Monitoring device. The study will include patients with diabetes and healthcare professionals. Patients will use Instara- 1 and will be followed up to assess device experience, glucose parameters, and diabetes-related quality of life. Healthcare professionals will evaluate device experience and preference, including comparison with FreeStyle Libre 2.

Подробное описание

This study aims to assess the real-world experience and perceived benefits of the Instara-1 Continuous Glucose Monitoring system among patients and healthcare professionals.

Patients diagnosed with diabetes will be enrolled after providing written informed consent. Instara-1 sensor placement will be performed at baseline, screening, and patients will be followed at Week 3, Week 6, Week 9, and Week 12 after CGM initiation. Patient assessments will include user experience, perceived benefits, preference, CGM-derived glucose parameters including estimated HbA1c and Time in Range, laboratory parameters including HbA1c, and diabetes-related quality of life using DQoL-13.

Healthcare professionals will participate to assess device-related experience, usability, preference, and comparison of Instara -1 with FreeStyle Libre 2. HCPs will complete the relevant user experience assessment at baseline before sensor insertion and at Week 3 after device use.

The primary outcomes will focus on perceived benefits, device experience, and preference related to CGM use among patients and HCPs. Secondary outcomes will assess changes in glucose-related parameters and diabetes-related quality of life among patients from baseline to the end of the study.

Вмешательства

• Устройство CGM
  Comparison of 2 devices by HCP

Первичные конечные точки

• Benefit, device experience and preference of continuous glucose monitoring by patients and HCPs [Срок оценки: From enrollment to the end of treatment at 3 weeks.]
• Sensor and mobile application experience of continuous glucose monitoring by patient and comparison with Free Style®Libre 2 [Срок оценки: From the time of enrollment to end of week 3.]

Вторичные конечные точки (4)

• eHbA1c% [Срок оценки: At week1, week 3, week 6, week 9 and week 12]
• Time in range (TIR), time above range (TAR) and time below range (TBR) . [Срок оценки: Week 1, week 3 , week 6, week 9 and week 12]
• Mean difference in HbA1c% from laboratory [Срок оценки: Baseline and at week 12]
• Mean difference in Quality of Life (DQoL 13) [Срок оценки: At baseline, week 6 and week 12]

Критерии участия

Критерии включения

• Subjects to provide written informed consent prior to any study procedures being performed
• Subjects with age 18 and above both male and female
• Diagnosed with Diabetes Miletus Type I, Type II and/or GDM
• Comfortable using smart phone, access to internet along with Bluetooth connectivity throughout the study duration.
• Subjects (Patients) on oral or injectable anti-diabetic medications, (in case of insulin, patient must be on insulin from last 3 months )
• Subjects (HCPs) healthy, Pre-diabetes or Diabetes Miletus (any type)

Критерии исключения

• History of hypersensitivity to any of the active or inactive ingredients of the CGM device used in the trial, and/or history of significant allergic skin reactions.
• Presence of severe diabetes complications e.g. retinopathy, acute metabolic crisis, etc.
• History of active/ acute renal and/or hepatic failure.
• Patients who have been admitted to the hospital in the past 3 months for diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
• History of critical illness or incapacitated patients
• History of acute psychiatric disorder or exacerbation of chronic psychiatric disorder.
• History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study.
• Medical conditions that require patients to undergo frequent radiation/ imaging procedures for example CT, MRI and X rays
• History of known hematological disorders such as Sickle Cell Disease \& Trait, Thalassemia, Hemolytic Anemias (e.g., G6PD deficiency, autoimmune), Iron Deficiency Anemia
• Patients on high doses of acetaminophen (>1 gram every 6 hours), ascorbic acid supplements (e.g., > 500-1000 mg/day), IV sorbitol, steroids and aspirin which can alter the readings on the CGM device.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07607015 · GTZ-CGM-018-05-26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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