CGM Experience, Preferences & Blood Glucose Parameters

N/ANot Yet RecruitingNCT07607015

Getz Pharma75 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabete Mellitus Type2diabetes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Benefit, device experience and preference of continuous glucose monitoring by patients and HCPs

A user experience questionnaire will be used to assesses how glucose monitoring helps in overall diabetes management, including understanding the effect of food, exercise, and stress on glucose levels, recognizing glucose trends, improving self-management and decision-making, increasing confidence and safety, supporting better communication with healthcare providers improving overall quality of life with diabetes. A 5 point Likert scale will be used to translate subjective experience into structured, comparable feedback

Time frame: 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

The study will use an evaluation Questionnaire focusing on the usability of the sensor and mobile app. To capture functional experience, behavioral and emotional impact a 5 point Likert scale will be used to translate subjective experience into structured, comparable feedback with 1 being strongly disagree and 5 being strongly agree. The questionnaire will include questions regarding, comfort of wearing the sensor, interference with daily life, pain or inconvenience, perceived reliability of glucose readings, system performance throughout use, overall user friendliness and willingness to use sensor again or recommend it to others.

Time frame: From the time of enrollment to end of week 3.

Secondary Outcomes

eHbA1c%

Time frame: At week1, week 3, week 6, week 9 and week 12

Time in range (TIR), time above range (TAR) and time below range (TBR) .

Time frame: Week 1, week 3 , week 6, week 9 and week 12

Mean difference in HbA1c% from laboratory

Time frame: Baseline and at week 12

Mean difference in Quality of Life (DQoL 13)

Time frame: At baseline, week 6 and week 12