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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Benefit, device experience and preference of continuous glucose monitoring by patients and HCPs
Timeframe: 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
Timeframe: From the time of enrollment to end of week 3.