Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy

NCT01921322 | Completed Results FDA Device

• 1 other identifier: CEP270
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Glycemic Variability

  Up to 14 days in hospital

Study Arms (2)

Pump

EXPERIMENTAL

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

Device: Pump

MDI

ACTIVE COMPARATOR

Multiple daily insulin injections used for treatment

Other: CGMS Gold

Interventions

Pump DEVICE

722 Paradigm Real-Time System

Pump

CGMS Gold OTHER

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

MDI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (2)

The Second Hospital of Jilin University

Changchun, Jilin, China

Location

Chinese PLA General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: John Shin, PhD
• Organization: Medtronic Diabetes

john.shin@medtronic.com

818-576-4019

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects randomly assigned to undergo treatment using either the Paradigm 722 insulin pump or multiple daily insulin injections.

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 13, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 6, 2017
• Results First Posted: July 6, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)