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This is a prospective, randomized (open label), multi-center and post-market study. The study is to compare effectiveness of sensor-augmented pump (SAP) therapy versus multiple daily injection (MDI) therapy in hospitalized patients with insulin treating type 2 diabetes in China
Full description
Primary objective:
To compare the length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus MDI
Secondary Objectives:
To compare glycemic variability (using CGM as reference method) with the 722 Paradigm Real-Time insulin pump versus MDI
This is a prospective, randomized (open label), multi-center study. The clinical study staff will conduct screening tests according to inclusion/exclusion criteria in order to verify the subject's eligibility for the study.
Inpatient Period A patient is admitted into hospital for treatment of diabetes
Randomization
Subjects are randomized (at a 1:1 ratio) to group A or B in the study database. A total of 80 subjects will be randomized into 2 study groups:
It is anticipated that the total duration for the study will be within one year from site initiation to finalization of all data entry and monitoring.
Each subject will participate in the study approximately 2 weeks.
Enrollment
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Inclusion criteria
Exclusion criteria
Subject has known hypersensitivity to insulin or insulin infusion set
Subject has been treated with drugs with a known effect on BG within 8 weeks before enrollment other than diabetes medications such as insulin or oral agents.
random blood glucose is above 33 mmol/L
Subject is currently using real time CGM therapy prior to screening
Subject is currently using insulin pump therapy prior to screening
Female subject who is pregnant, or plans to become pregnant during the course of the study
Patients who are critically ill that must go to intensive critical care unit per Investigator discretion
Subject has any systemic disease or medical condition found on the screening tests that may interfere with the safety of the patient and efficacy of the study treatment, in the opinion of the Investigator, may preclude him/her from participating in the study. The following includes, but not limited to, those conditions:
Any other condition, which may not be suitable for the study at physician's discretion.
Primary purpose
Allocation
Interventional model
Masking
118 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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