Status:
COMPLETED
Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy
Lead Sponsor:
Medtronic Diabetes
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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) t...
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 M...
Eligibility Criteria
Inclusion
- Subject is 18 to 65 years old at time of screening
- A clinical diagnosis of type 2 diabetes \> 6 months prior to the screening as determined by the Investigator,
- Treating with insulin at least one injection per day prior to participate in the study
- Glycosylated hemoglobin (A1C) \> 8% at screening
- Subject needs to be hospitalized to receive treatment for glucose management according to Endocrinologists' discretion
- Subject is willing to follow protocol and underdo all study procedures
- Subject is willing and able to provide informed written consent personally or by legal proxy
Exclusion
- 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:
- Female subject has a positive serum pregnancy screening test
- Subject has visually impaired or disability limits the use of RT-CGM.
- Subject has any unresolved adverse skin condition in the area of sensor placement or device replacement (e.g., psoriasis, rash, Staphylococcus infection)
- Subject has disease with a known effect on BG such as Active Graves' disease
- Subject has a history of alcohol abuse
- Any other condition, which may not be suitable for the study at physician's discretion.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01921322
Start Date
April 1 2013
End Date
May 1 2015
Last Update
July 6 2017
Active Locations (2)
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1
The Second Hospital of Jilin University
Changchun, Jilin, China
2
Chinese PLA General Hospital
Beijing, China