CGM Experience, Preferences & Blood Glucose Parameters

May 19, 2026 updated by: Getz Pharma

Instara™-1 Dual Perspectives on Continuous Glucose Monitoring: Understanding Patient Experience and Healthcare Professional Preferences

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Instara-1 CGM
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.
Device: CGM
Comparison of 2 devices by HCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Benefit, device experience and preference of continuous glucose monitoring by patients and HCPs
Time Frame: From enrollment to the end of treatment at 3 weeks.
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
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
Time Frame: From the time of enrollment to end of week 3.
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.
From the time of enrollment to end of week 3.

Secondary Outcome Measures

Outcome Measure
Time Frame
eHbA1c%
Time Frame: At week1, week 3, week 6, week 9 and week 12
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
Week 1, week 3 , week 6, week 9 and week 12
Mean difference in HbA1c% from laboratory
Time Frame: Baseline and at week 12
Baseline and at week 12
Mean difference in Quality of Life (DQoL 13)
Time Frame: At baseline, week 6 and week 12
At baseline, week 6 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Getz Pharma

Collaborators

Peshawar General Hospital

Investigators

  • Study Director: Jahanzeb Kamal Khan, MCPS, CPSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 10, 2026

Primary Completion (Estimated)

August 10, 2027

Study Completion (Estimated)

August 10, 2027

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTZ-CGM-018-05-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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