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
Qualifiers
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 design
Treatments tested in this trial
- CGM
Treatment groups
75 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Getz Pharma
Lead sponsor
Peshawar General Hospital
Collaborator
Source ClinicalTrials.gov