Type 2 Diabetes
Conditions
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.
Interventions
DEVICEPump
722 Paradigm Real-Time System
OTHERCGMS Gold
Device used to collect retrospective sensor data, blinded to the subjects, to compare to the treatment arm
Sponsors
Medtronic Diabetes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects randomly assigned to undergo treatment using either the Paradigm 722 insulin pump or multiple daily insulin injections.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Target | Up to 14 days in hospital | 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
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Variability | Up to 14 days in hospital | Glycemic variability (mean amplitude glycemic excursion) using CGM as reference method |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pump Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring | 40 |
| Multiple Daily Injections Multiple daily insulin injections used for treatment | 41 |
| Total | 81 |
Baseline characteristics
| Characteristic | Total | Multiple Daily Injections | Pump |
|---|---|---|---|
| A1C (%) | 10 % STANDARD_DEVIATION 1.4 | 10 % STANDARD_DEVIATION 1.2 | 10 % STANDARD_DEVIATION 1.6 |
| Age, Continuous | 50 years STANDARD_DEVIATION 9.9 | 49 years STANDARD_DEVIATION 9.6 | 51 years STANDARD_DEVIATION 10.2 |
| BMI (kg/m2) | 25 kg/m2 STANDARD_DEVIATION 3.1 | 25 kg/m2 STANDARD_DEVIATION 3.3 | 25 kg/m2 STANDARD_DEVIATION 3.1 |
| Height (cm) | 167 cm STANDARD_DEVIATION 7.8 | 168 cm STANDARD_DEVIATION 7.6 | 167 cm STANDARD_DEVIATION 8.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 81 Participants | 41 Participants | 40 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 32 Participants | 17 Participants | 15 Participants |
| Sex: Female, Male Male | 49 Participants | 24 Participants | 25 Participants |
| Weight (kg) | 71 kg STANDARD_DEVIATION 11.2 | 72 kg STANDARD_DEVIATION 10.7 | 71 kg STANDARD_DEVIATION 11.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 61 |
| other Total, other adverse events | 1 / 57 | 1 / 61 |
| serious Total, serious adverse events | 0 / 57 | 0 / 61 |
Outcome results
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
Time frame: Up to 14 days in hospital
Population: subjects included in final analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pump | Time to Target | 3.7 days | Standard Deviation 1.1 |
| Multiple Daily Injections | Time to Target | 6.3 days | Standard Deviation 3.1 |
Secondary
Glycemic Variability
Glycemic variability (mean amplitude glycemic excursion) using CGM as reference method
Time frame: Up to 14 days in hospital
Population: subjects incluced in final analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pump | Glycemic Variability | 3.55 mmol/L | Standard Deviation 1.89 |
| Multiple Daily Injections | Glycemic Variability | 3.44 mmol/L | Standard Deviation 1.85 |