CGM Experience, Preferences & Blood Glucose Parameters

Getz Pharma

Status: Begins enrollment in 2 months

Conditions: Gestational Diabetes; Type2diabetes; Diabete Mellitus; Pre Diabetes; type1diabetes

Treatments: Device: CGM

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07607015

GTZ-CGM-018-05-26

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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.

Trial design

75 participants in 1 patient group

Instara-1 CGM

Description:

Participants in this arm will use the Instara-1 Continuous Glucose Monitoring . Patients will be followed for device experience, perceived benefits, preference, glucose-related parameters, and diabetes-related quality of life. Healthcare professionals will assess device experience and preference, including comparison with FreeStyle Libre 2 where applicable.

Treatment:

Device: CGM