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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pump | Experimental | Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring |
|
| MDI | Active Comparator | Multiple daily insulin injections used for treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pump | Device | 722 Paradigm Real-Time System |
| |
| CGMS Gold |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Variability | Glycemic variability (mean amplitude glycemic excursion) using CGM as reference method | Up to 14 days in hospital |
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Inclusion Criteria:
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:
Any other condition, which may not be suitable for the study at physician's discretion.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Jilin University | Changchun | Jilin | China | |||
| Chinese PLA General Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pump | Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring |
| FG001 | Multiple Daily Injections | Multiple daily insulin injections used for treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Amoung the study completers, four met the target range on or before the first day and one subjects blinded CGM data was lost due to removal of the devices battery. The five subjects were excluded from the final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pump | Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring |
| BG001 | Multiple Daily Injections | Multiple daily insulin injections used for treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | subjects included in final analysis | Posted | Mean | Standard Deviation | days | Up to 14 days in hospital |
|
up to 14 days in hospital
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pump | Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bleeding | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Shin, PhD | Medtronic Diabetes | 818-576-4019 | john.shin@medtronic.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Subjects randomly assigned to undergo treatment using either the Paradigm 722 insulin pump or multiple daily insulin injections.
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| Other |
Device used to collect retrospective sensor data, blinded to the subjects, to compare to the treatment arm |
|
| Beijing |
| China |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| BMI (kg/m2) | Mean | Standard Deviation | kg/m2 |
|
| A1C (%) | Mean | Standard Deviation | % |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Glycemic Variability | Glycemic variability (mean amplitude glycemic excursion) using CGM as reference method | subjects incluced in final analysis | Posted | Mean | Standard Deviation | mmol/L | Up to 14 days in hospital |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 1 |
| 57 |
| EG001 | Multiple Daily Injections | Multiple daily insulin injections used for treatment | 0 | 61 | 0 | 61 | 1 | 61 |
| allergic reaction | Immune system disorders | Non-systematic Assessment |
|
| infection | Infections and infestations | Non-systematic Assessment |
|
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| D004700 | Endocrine System Diseases |