Diabete MellitusNCT07607015
CGM Experience, Preferences & Blood Glucose Parameters
An observational study of Diabete Mellitus and Type2diabetes, run by Getz Pharma.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Mellitus, Type2diabetes, type1diabetes
- What is being tested?
- CGM
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 10 Aug 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- CGM
- Keywords
- CGM, Glucose monitoring, Time in range, estimated HbA1c, Time above range, Time below range, Diabetes Quality of life
- Medical subject headings
- Diabetes Mellitus, Diabetes, Gestational, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMDevice
Comparison of 2 devices by HCP
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: From the time of enrollment to end of week 3.
Secondary outcomes (4)
eHbA1c%
Measured: At week1, week 3, week 6, week 9 and week 12
Time in range (TIR), time above range (TAR) and time below range (TBR) .
Measured: Week 1, week 3 , week 6, week 9 and week 12
Mean difference in HbA1c% from laboratory
Measured: Baseline and at week 12
Mean difference in Quality of Life (DQoL 13)
Measured: At baseline, week 6 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start10 Sep 2026 (estimated)
- Primary completion10 Aug 2027 (estimated)
- Study completion10 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Getz Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peshawar General Hospital
- Responsible party
- Sponsor
- Investigators
- Jahanzeb Kamal Khan, MCPS, Study director, CPSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607015
- Sponsor's protocol ID
- GTZ-CGM-018-05-26
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided