CGM Experience, Preferences & Blood Glucose Parameters
19 maj 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
75
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jahanzeb Kamal Khan, MCPS
- Telefonnummer: +923201212945
- E-post: jahanzeb.kamal@getzpharma.com
Studera Kontakt Backup
- Namn: Nauman Muhammad Sheikh, MBBS
- Telefonnummer: +923201212981
- E-post: nauman.shaikh@getzpharma.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Benefit, device experience and preference of continuous glucose monitoring by patients and HCPs
Tidsram: 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
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
eHbA1c%
Tidsram: 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) .
Tidsram: 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
Tidsram: Baseline and at week 12
|
Baseline and at week 12
|
|
Mean difference in Quality of Life (DQoL 13)
Tidsram: At baseline, week 6 and week 12
|
At baseline, week 6 and week 12
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Jahanzeb Kamal Khan, MCPS, CPSP
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
10 september 2026
Primärt slutförande (Beräknad)
10 augusti 2027
Avslutad studie (Beräknad)
10 augusti 2027
Studieregistreringsdatum
Först inskickad
19 maj 2026
Först inskickad som uppfyllde QC-kriterierna
19 maj 2026
Första postat (Faktisk)
26 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GTZ-CGM-018-05-26
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .