Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy

NCT ID: NCT01921322

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-05-31

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) 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pump

Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring

Group Type: EXPERIMENTAL

Pump

Intervention Type: DEVICE

722 Paradigm Real-Time System

MDI

Multiple daily insulin injections used for treatment

Group Type: ACTIVE_COMPARATOR

CGMS Gold

Intervention Type: OTHER

Device used to collect retrospective sensor data, blinded to the subjects, to compare to the treatment arm

Interventions

Pump

722 Paradigm Real-Time System

Intervention Type: DEVICE

CGMS Gold

Device used to collect retrospective sensor data, blinded to the subjects, to compare to the treatment arm

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Subject is 18 to 65 years old at time of screening

2. A clinical diagnosis of type 2 diabetes > 6 months prior to the screening as determined by the Investigator,

3. Treating with insulin at least one injection per day prior to participate in the study

4. Glycosylated hemoglobin (A1C) > 8% at screening

5. Subject needs to be hospitalized to receive treatment for glucose management according to Endocrinologists' discretion

6. Subject is willing to follow protocol and underdo all study procedures

7. Subject is willing and able to provide informed written consent personally or by legal proxy

Exclusion Criteria

1. Subject has known hypersensitivity to insulin or insulin infusion set

2. 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.

3. random blood glucose is above 33 mmol/L

4. Subject is currently using real time CGM therapy prior to screening

5. Subject is currently using insulin pump therapy prior to screening

6. Female subject who is pregnant, or plans to become pregnant during the course of the study

7. Patients who are critically ill that must go to intensive critical care unit per Investigator discretion

8. 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

9. Any other condition, which may not be suitable for the study at physician's discretion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Hospital of Jilin University

Changchun, Jilin, China

Chinese PLA General Hospital

Beijing, , China

Countries

China

Other Identifiers

CEP270

Identifier Type: -

Identifier Source: org_study_id