Diabetes
Conditions
Keywords
Diabetes, Insulin pump, Threshold Suspend
Brief summary
The purpose of this study is to evaluate the Threshold Suspend (TS) feature of the Medtronic MiniMed® 530G insulin pump in patients 16 and older with insulin requiring diabetes.
Detailed description
Multi-center trial is initiated to observe the Threshold Suspend (TS) feature with a sensor-augmented insulin pump (Medtronic MiniMed® 530G insulin pump) in patients 16 and older with insulin requiring diabetes over a period of one year.
Interventions
DEVICEMedtronic MiniMed 530G Insulin Pump
Sponsors
Medtronic Diabetes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects are assigned to treatment with the Medtronic 530G Insulin Pump
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is age 16 or older at time of screening 2. Subject has been diagnosed with diabetes mellitus for at least one year prior to screening. 3. Subject is currently on pump therapy. 4. Subject is transitioning to the 530G insulin pump system with the TS feature turned ON. 5. Subject is willing to complete all study related activities 6. Subject is willing to upload data every 21 days from the study pump 7. Subject must have Internet access and access to a computer system that meets the requirements for uploading the pumps. This may include use of family or friend's computer system with Internet access. 8. Subject is able (by insurance or financial means) to cover the initial investment and ongoing cost of the 530G insulin pump and consumables, CGM, Bayer CONTOUR Next Link RF enabled meter and supplies for the length of the study- 1 year.
Exclusion criteria
1. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study devices in the last 2 weeks. 2. Subject is a woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study 3. Subject is being treated for hyperthyroidism at time of screening 4. Subject has an abnormality (\>1.8mg/dL) in creatinine at time of screening visit 5. Subject has an abnormality (out of reference range) in thyroid-stimulating hormone (TSH) at time of screening visit. If TSH is out of range, Free T3 and Free T4 will be tested. Subject may be included with TSH out of range as long as Free T3 and Free T4 are in normal reference range. 6. Subject has taken any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study 7. Subject is currently abusing illicit drugs 8. Subject is currently abusing prescription drugs 9. Subject is currently abusing alcohol 10. Subject has sickle cell disease or hemoglobinopathy 11. Subject has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening or plans to receive red blood cell transfusion or erythropoietin over the course of study participation 12. Subject diagnosed with current eating disorder such as anorexia or bulimia 13. Subject has been diagnosed with chronic kidney disease that results in chronic anemia 14. Subject is on dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in A1C From Baseline to 1 Year | 1 year | Comparison of A1C measurement from baseline to end of study in the CEP266 study population. The overall mean change in A1C from baseline will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided) with the CEP 266 study population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7% | 1 year | Mean Change in A1C From Baseline to 1 Year, for subjects with baseline A1c below 7%. |
| Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9% | 1 year | Mean Change in A1C From Baseline to 1 Year, for subjects with Baseline A1c of 7% to 9% |
| Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9% | 1 year | Mean Change in A1C From Baseline to 1 year, for subjects with Baseline A1c \> 9% |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medtronic MiniMed 530G Insulin Pump All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.
Medtronic MiniMed 530G Insulin Pump | 372 |
| Total | 372 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | Withdrawal by Subject | 52 |
Baseline characteristics
| Characteristic | Medtronic MiniMed 530G Insulin Pump |
|---|---|
| Age, Continuous | 45.5 Years STANDARD_DEVIATION 15.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 351 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Region of Enrollment United States | 372 participants |
| Sex: Female, Male Female | 201 Participants |
| Sex: Female, Male Male | 171 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 372 |
| other Total, other adverse events | 37 / 372 |
| serious Total, serious adverse events | 19 / 372 |
Outcome results
Primary
Mean Change in A1C From Baseline to 1 Year
Comparison of A1C measurement from baseline to end of study in the CEP266 study population. The overall mean change in A1C from baseline will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided) with the CEP 266 study population.
Time frame: 1 year
Population: Among the 372 enrolled subjects, 298 had both baseline and end of study A1c.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Medtronic MiniMed 530G Insulin Pump | Mean Change in A1C From Baseline to 1 Year | 0.034 percentage |
95% CI: [-0.03, 0.098]
Secondary
Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9%
Mean Change in A1C From Baseline to 1 year, for subjects with Baseline A1c \> 9%
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtronic MiniMed 530G Insulin Pump | Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9% | -0.39 percentage | Standard Deviation 0.96 |
Secondary
Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%
Mean Change in A1C From Baseline to 1 Year, for subjects with baseline A1c below 7%.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtronic MiniMed 530G Insulin Pump | Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7% | 0.32 percentage | Standard Deviation 0.53 |
Secondary
Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9%
Mean Change in A1C From Baseline to 1 Year, for subjects with Baseline A1c of 7% to 9%
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtronic MiniMed 530G Insulin Pump | Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9% | -0.04 percentage | Standard Deviation 0.67 |