Back to results

Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Pump

CGMS Gold

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

The Second Hospital of Jilin University
Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pump

MDI

Arm Description

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

Multiple daily insulin injections used for treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Glycemic Variability

Glycemic variability (mean amplitude glycemic excursion) using CGM as reference method

Full Information

NCT ID

NCT01921322

First Posted

August 9, 2013

Last Updated

June 6, 2017

Sponsor

Medtronic Diabetes

1. Study Identification

Unique Protocol Identification Number

NCT01921322

Brief Title

Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Diabetes

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

118 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pump

Arm Type

Experimental

Arm Description

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

Arm Title

MDI

Arm Type

Active Comparator

Arm Description

Multiple daily insulin injections used for treatment

Intervention Type

Device

Intervention Name(s)

Pump

Intervention Description

722 Paradigm Real-Time System

Intervention Type

Other

Intervention Name(s)

CGMS Gold

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to Target

Description

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

Time Frame

Up to 14 days in hospital

Secondary Outcome Measure Information:

Title

Glycemic Variability

Description

Glycemic variability (mean amplitude glycemic excursion) using CGM as reference method

Time Frame

Up to 14 days in hospital

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

The Second Hospital of Jilin University

City

Changchun

State/Province

Jilin

Country

China

Facility Name

Chinese PLA General Hospital

City

Beijing

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy

We'll reach out to this number within 24 hrs