Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy

Medtronic

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Device: Pump

Other: CGMS Gold

Study type

Interventional

Funder types

Industry

Identifiers

NCT01921322

CEP270

Details and patient eligibility

About

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:

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.

Enrollment

118 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 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:
- 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.