NCT01921322

Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy

Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy for Hospitalized Patients in China With Type 2 Diabetes; Time to Target

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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: * 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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	Pump	722 Paradigm Real-Time System
OTHER	CGMS Gold	Device used to collect retrospective sensor data, blinded to the subjects, to compare to the treatment arm

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2013-08-13
• Last updated: 2017-07-06
• Results posted: 2017-07-06

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated device study