NCT07607015

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Sep 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 10, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2027

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

May 19, 2026

Last Update Submit

May 19, 2026

Conditions

Diabete MellitusType2diabetestype1diabetesGestational DiabetesPre Diabetes

Keywords

CGMGlucose monitoringTime in rangeestimated HbA1cTime above rangeTime below rangeDiabetes Quality of life

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    From the time of enrollment to end of week 3.

Secondary Outcomes (4)

  • eHbA1c%

    At week1, week 3, week 6, week 9 and week 12

  • Time in range (TIR), time above range (TAR) and time below range (TBR) .

    Week 1, week 3 , week 6, week 9 and week 12

  • Mean difference in HbA1c% from laboratory

    Baseline and at week 12

  • Mean difference in Quality of Life (DQoL 13)

    At baseline, week 6 and week 12

Study Arms (1)

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

Interventions

CGMDEVICE

Comparison of 2 devices by HCP

Instara-1 CGM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes, GestationalGlucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHyperglycemia

Study Officials

  • Jahanzeb Kamal Khan, MCPS

    CPSP

    STUDY DIRECTOR

Central Study Contacts

Jahanzeb Kamal Khan, MCPS

CONTACT

+923201212945jahanzeb.kamal@getzpharma.com

Nauman Muhammad Sheikh, MBBS

CONTACT

+923201212981nauman.shaikh@getzpharma.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 26, 2026

Study Start (Estimated)

September 10, 2026

Primary Completion (Estimated)

August 10, 2027

Study Completion (Estimated)

August 10, 2027

Last Updated

May 26, 2026

Record last verified: 2026-05