CGM Experience, Preferences & Blood Glucose Parameters
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGetz Pharma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Study participants will be selected from diabetes clinics/healthcare facilities all across Pakistan. The patient population will include adults with diabetes mellitus who are eligible for CGM use as per the study protocol. The HCP population will include healthcare professionals involved in diabetes care, including healthy, pre-diabetic, or diabetic individuals, as applicable to the study arm.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
CGM
DeviceComparison of 2 devices by HCP
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Instara-1 CGM1 intervention
Trial outcomes
Primary outcomes
1
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.2
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
1
eHbA1c%
Time frame
At week1, week 3, week 6, week 9 and week 122
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 123
Mean difference in HbA1c% from laboratory
Time frame
Baseline and at week 124
Mean difference in Quality of Life (DQoL 13)
Time frame
At baseline, week 6 and week 12Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Getz Pharma
Lead sponsor
Peshawar General Hospital
Collaborator
Source ClinicalTrials.gov
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