Type 2 Diabetes Clinical Trial
Official title:
Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy for Hospitalized Patients in China With Type 2 Diabetes; Time to Target
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
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:
- Group A will wear 722 Paradigm Real-Time System (treated with 24h per day insulin
infusion)
- Group B will be on MDI and wear the CGMS-Gold (treated with 4 insulin injections).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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