Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy
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|ClinicalTrials.gov Identifier: NCT01921322|
Recruitment Status : Completed
First Posted : August 13, 2013
Results First Posted : July 6, 2017
Last Update Posted : July 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Device: Pump Other: CGMS Gold||Not Applicable|
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
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
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects randomly assigned to undergo treatment using either the Paradigm 722 insulin pump or multiple daily insulin injections.|
|Masking:||None (Open Label)|
|Official Title:||Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy for Hospitalized Patients in China With Type 2 Diabetes; Time to Target|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
722 Paradigm Real-Time System
Active Comparator: MDI
Multiple daily insulin injections used for treatment
Other: CGMS Gold
Device used to collect retrospective sensor data, blinded to the subjects, to compare to the treatment arm
- Time to Target [ Time Frame: Up to 14 days in hospital ]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 Multiple Daily Injection
- Glycemic Variability [ Time Frame: Up to 14 days in hospital ]Glycemic variability (mean amplitude glycemic excursion) using CGM as reference method
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921322
|The Second Hospital of Jilin University|
|Changchun, Jilin, China|
|Chinese PLA General Hospital|