Safety and Performance Evaluation of the SAVA Continuous Glucose Monitor for Effective Glucose Detection

Обзор

The goal of this clinical trial is to evaluate the safety and performance of the SAVA Continuous Glucose Monitor across glucose ranges over a period of 15-day wear in adults over 18 years of age with Type 1 Diabetes. This is a pilot study, so the main purposes are to collect preliminary data for future studies, assess comfort and safety, and explore the accuracy of the CGM against references and benchmarks.

Вмешательства

• Устройство CGM Devices
  Each participant will wear 3 SAVA CGMs and 1 commercially available CGM

Первичные конечные точки

• Paired Sensor-Venous Blood Glucose Readings [Срок оценки: For the duration of time the participant is wearing the CGM device (Day 0 to Day 14; up to 15 days)]

Вторичные конечные точки (5)

• Assessment of comfort associated with devices at insertion and removal [Срок оценки: At device application (Day 0) and removal (up to Day 14)]
• Assessment of duration of pain associated with devices at insertion and removal [Срок оценки: At device application (Day 0) and removal (up to Day 14)]
• Evaluation of skin response at device wear sites [Срок оценки: At device application (Day 0) and removal (up to Day 14)]
• Characterisation of the safety profile of the SAVA CGMs [Срок оценки: Up to 15 days (Day 14)]
• Description of SAVA CGM clinical safety profile [Срок оценки: Up to 15 days (Day 14)]

Критерии участия

Критерии включения

• The participant is willing and able to give informed consent to participate in the study.
• The participant is at least 18 years of age at the time of enrolment.
• The participant has a clinical diagnosis of Type 1 diabetes, with 7% < HbA1C < 10% within the last 6 months, for a minimum of 6 months duration prior to enrolment, as determined by a medical record by an individual qualified to make a medical diagnosis, and is using insulin (either by an insulin pump, subcutaneous injections, and/or inhaled insulin) for at least 6 months prior to enrolment.
• If participant is using noninsulin glucose-lowering medications (such as SGLT2I Inhibitor, Metformin, or other), dose has been stable for at least 2 weeks prior to screening.
• The participant body weight is at least 110 pounds, in accordance with U.S. Department of Health and Human Services guidance for blood collection.
• The participant has adequate venous access as assessed by an investigator or appropriate centre staff.
• The participant is available to attend all three up to 8-hour, clinically supervised, in-clinic sessions and to have multiple venous and capillary blood samples collected.
• The participant agrees to not consume Vitamin C for the duration of the study.
• The participant is prepared to record details related to their participation (e.g. meals, finger prick times, device incidents, comfort) daily.
• The participant is prepared to wear up to three blinded investigational devices, and one unblinded investigational device for 15 days.
• In the investigators' opinion, are suitable for participation in the study.
• The participant is able to read and understand English.
• The participant is willing to return the research devices at the end of the study.
• The participant is willing to manage diabetes with insulin during study visits as they would do otherwise.
• The participant can commit to not getting the CGMs wet for the first 12 hours after application, such as by showering or swimming.

Критерии исключения

• The participant gave birth within the last 6 months, is pregnant, is trying to conceive or is not willing and able to practice birth control during the study duration.
• The participant has serious concomitant disorders or diseases (e.g. history of hypoglycaemia with unawareness requiring third party assistance, coagulation disorders) that would compromise the safety of the participant or their ability to complete the study, at the discretion of the Investigator.
• The participant has had a recent cardiovascular event or major surgery in the last 6 months that would compromise the safety of the participant or their ability to complete the study, at the discretion of the Investigator.
• The participant has been admitted to the hospital with Diabetic Ketoacidosis in the last 6 months prior to enrolment.
• The participant has donated more than 500mL of blood in the past 4 weeks.
• The participant has a blood haemoglobin (Hb) that is 10% or more below the normal reference range for men and women, at the discretion of the Investigator.
• Current use of sulfonylurea medications.
• Current use of GLP-1 Receptor Agonist medications.
• The participant has an implanted medical device such as a pacemaker or an implantable cardioverter-defibrillator (ICD).
• The participant has multiple tattoos, scars, active skin condition or wound, or significant dermatitis overlying the skin where devices are likely to be placed.
• The participant has a known allergy or sensitivity to skin adhesives or sensor materials.
• The participant is taking part in another interventional clinical study requiring blood sampling, an investigational drug or device during the 15-day wear period of this study.
• The participant is not willing to suspend their hybrid closed loop (Automated Insulin Delivery) system during the clinic sampling session.
• The participant has any X-ray or MRI scheduled at any time during the participation of the study.
• Any other reason which, in the investigator's opinion, would compromise participant safety or data integrity.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07679347 · SPEED-SUB-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗