CEP270 China SAP Study

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921322
• Other study ID #: CEP270
• Status: Completed
• Phase: Phase 2
• First received: August 9, 2013
• Last updated: October 26, 2015
• Start date: April 2013
• Est. completion date: May 2015

Study information

• Verified date: October 2015
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• Pump

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing
China	The Second Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to target	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	14 days in hospital	No
Secondary	Glycemic variability	Glycemic variability (using CGM as reference method) with the 722 Paradigm Real-Time insulin pump versus MDI	14 days in hospital	No