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CGM Experience, Preferences & Blood Glucose Parameters

19. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

75

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Comparison of 2 devices by HCP

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Benefit, device experience and preference of continuous glucose monitoring by patients and HCPs
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tidsramme
eHbA1c%
Tidsramme: 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) .
Tidsramme: 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
Tidsramme: Baseline and at week 12
Baseline and at week 12
Mean difference in Quality of Life (DQoL 13)
Tidsramme: At baseline, week 6 and week 12
At baseline, week 6 and week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Efterforskere

  • Studieleder: Jahanzeb Kamal Khan, MCPS, CPSP

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

10. september 2026

Primær færdiggørelse (Anslået)

10. august 2027

Studieafslutning (Anslået)

10. august 2027

Datoer for studieregistrering

Først indsendt

19. maj 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kliniske forsøg med CGM

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