Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: Pump; Other: CGMS Gold

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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Chinese PLA General Hospital
  • Jilin
    • Changchun, Jilin, China
      • The Second Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pump; Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring	Device: Pump; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 14 days in hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Variability	Glycemic variability (mean amplitude glycemic excursion) using CGM as reference method	Up to 14 days in hospital

Collaborators and Investigators

• Sponsor: Medtronic Diabetes

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: August 9, 2013
• First Submitted That Met QC Criteria: August 12, 2013
• First Posted (Estimate): August 13, 2013

Study Record Updates

• Last Update Posted (Actual): July 6, 2017
• Last Update Submitted That Met QC Criteria: June 6, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CEP270

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes