Status:
ENROLLING_BY_INVITATION
To Evaluate the Change in Glucose Parameters in Adult Patients With Type 1 or Type 2 Diabetes From Europe Using the iCan o3 CGM System for 60 Days Period
Lead Sponsor:
Sinocare
Collaborating Sponsors:
Archer Research
Conditions:
Diabetes Mellitus
Continuous Glucose Monitoring System
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study is a post-market, prospective, interventional, multicenter clinical trial designed to evaluate the impact of the iCan O3 Continuous Glucose Monitoring (CGM) System on glycemic control in ad...
Eligibility Criteria
Inclusion
- Patient age is between 18 and 75 years old. Patient age is between 18 and 75 years old.
- Patient is clinically diagnosed with diabetes for at least 6 months (all treatment modalities are allowed).
- Patient has a Hemoglobin A1c (HbA1c) of \> 7,5%.
- Patient is sensor naive.
- Patient is willing to wear the device on the abdomen for the whole study period.
- Patient has a stable (unchanged) treatment regimen for at least 3 months. "Stable treatment regimen" is considered no changes in prescribed number of insulin deliveries a day, and a change in total daily insulin dose of less than 10%. Patients currently taking glucagon-like peptide-1 (GLP1) analogs before the study can be included.
- Patient has a compatible smartphone.
- Patient shows sufficient skills using a smartphone and apps, as judged by the investigator.
- Patient and investigator signed and dated the informed consent form prior to first sensor placement.
Exclusion
- Patient was hospitalized because of hyperglycemia/ketoacidosis within the last 6 months.
- Patient was hospitalized because of hypoglycemia within the last 6 months.
- Patient has a condition which may predispose him/her to hypoglycemia including, but not limited to, thyroid disease which is not well controlled, adrenal insufficiency, high dose steroid use in recent past or planned during study, significant renal or liver disease.
- Patient has a planned magnetic resonance imaging (MRI), Computed Tomography (CT) scan or diathermic procedure during the period of sensor wear.
- Patient with a significant medical or psychiatric disorder, or use of a medication which will affect the application of the protocol judged by the investigator.
- Patient with cognitive difficulties that may impair the ability to follow the protocol judged by the investigator.
- Patient is critically ill.
- Patient has a coagulation disorder or takes heparin-like antiplatelet medication.
- Patient is pregnant or is intending to become pregnant during the study period.
- Patient does not take clinically acceptable contraception or does not practice abstinence.
- Patient has a history of skin adhesive tolerance issues in the area of sensor placement.
- Patient has abnormal skin at the anticipated glucose sensor insertion sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
- Patient has any medical history of malignant melanoma or breast cancer.
- Patient has a medical history of any other cancers within the last five years except adequately treated basal cell or squamous carcinoma of the skin, or cervical carcinoma in-situ.
- Patient has a history of alcohol or drug abuse within the last year.
- Patient has a history of a seizure disorder.
- Patient has a medical history of stroke, transitory cerebral ischemia, myocardial infarction, unstable angina or heart failure with in the past 12 months.
- Patient is on dialysis.
- Patient is implanted with a pacemaker.
- Patient is currently being treated with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator.
- Patient has a concomitant pathology that might cause edema at the insertion sites (such as heart failure, liver failure, kidney failure defined as estimated Glomerular Filtration Rate (eGFR) \<30 mL/min \[stage ≥4\]).
- Patient underwent beta-cell transplantation.
- Patient is unable / unwilling to provide informed consent.
- Patient is unable to comply with the protocol or proposed study visits.
- Patient who is currently enrolled in another clinical study, or has recently participated in a clinical study, that could potentially interfere with the outcomes or introduce bias into the results of the current study (as determined by the investigator). This includes studies involving investigational drugs, medical devices, or other interventions that could impact the safety, efficacy, or scientific integrity of this study.
- Other reasons that require the investigator to exclude the patient from the study.
Key Trial Info
Start Date :
April 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06904846
Start Date
April 23 2025
End Date
November 30 2025
Last Update
May 21 2025
Active Locations (1)
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1
UZA ANTWERP UZA Dienst Endocrinologie
Antwerp, Belgium