Type 1 Diabetes
Conditions
Keywords
Type 1 diabetes, Pediatric, Threshold Suspend, Sensor augmented pump
Brief summary
The study objective is to demonstrate that home use of Threshold Suspend (TS) is not associated with glycemic deterioration in pediatric patients with type 1 diabetes, as measured by change in A1C.
Detailed description
This study is a longitudinal, multi-center trial that aims to observe the Threshold Suspend (TS) feature with a sensor-augmented insulin pump in patients 7-15 years with Type 1 diabetes. The study will measure the change in A1C from baseline over a period of one year while subjects are wearing the study pump.
Interventions
DEVICE530G Insulin pump
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
Sponsors
Medtronic Diabetes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single group
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is age 2 to 15 at time of screening 2. Subject has been diagnosed with type 1 diabetes mellitus and must have been diagnosed for at least one year prior to screening 3. Subject is currently transitioning from pump therapy, with or without continued glucose monitoring (CGM), to the 530G insulin pump system. 4. Subject is willing to perform greater than or equal to 4 finger stick blood glucose measurements daily 5. Subject is willing to perform required sensor calibrations 6. Subject is willing to wear the system (Pump, glucose sensors, meter) continuously throughout the study 7. Subject is willing to upload data every 21 days from the study pump 8. 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. 9. Subject is using either Humalog or Novolog at time of Screening and plans to use either of those insulins throughout the study
Exclusion criteria
1. Subject is actively participating in an investigational study (drug or device) wherein he/she is receiving treatment from an investigational study drug or investigational study device. 2. Women of child-bearing potential who have a positive pregnancy test at screening or plan 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 is using pramlintide (Symlin) at time of screening 11. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening 12. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation 13. Subject diagnosed with current eating disorder such as anorexia or bulimia 14. Subject has been diagnosed with chronic kidney disease that results in chronic anemia 15. Subject is on dialysis 16. Subject is already on a 530G system with CGM for 8 days or more.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Mean Change in A1C | Baseline and 1 year after screening | The overall mean change in A1C from baseline to 1 year 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). Among the 136 subjects who completed the study, 132 had both baseline and end of study A1c. Therefore, primary endpoint was based on 132 subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups | Baseline and 1 year after screening | Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c below 7%. Among the 132 subjects with both baseline and end of study A1c, 3 had A1c below 7% |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 530G Insulin Pump Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
530G Insulin pump: Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year. | 194 |
| Total | 194 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Due to insurance coverage | 1 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Withdrawal by Subject | 43 |
Baseline characteristics
| Characteristic | 530G Insulin Pump |
|---|---|
| Age, Continuous | 11.7 years STANDARD_DEVIATION 2.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 164 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Region of Enrollment United States | 194 particpants |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 194 |
| other Total, other adverse events | 121 / 194 |
| serious Total, serious adverse events | 4 / 194 |
Outcome results
Primary
Overall Mean Change in A1C
The overall mean change in A1C from baseline to 1 year 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). Among the 136 subjects who completed the study, 132 had both baseline and end of study A1c. Therefore, primary endpoint was based on 132 subjects.
Time frame: Baseline and 1 year after screening
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 530G Insulin Pump | Overall Mean Change in A1C | 0.26 percentage |
95% CI: [0.125, 0.395]
Secondary
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c below 7%. Among the 132 subjects with both baseline and end of study A1c, 3 had A1c below 7%
Time frame: Baseline and 1 year after screening
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 530G Insulin Pump | Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups | 0.37 percentage | Standard Deviation 0.47 |
Secondary
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c 7% to 9%. Among the 132 subjects with both baseline and end of study A1c, 97 had A1c 7% to 9%
Time frame: Baseline and 1 year after screening
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 530G Insulin Pump | Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups | 0.34 percentage | Standard Deviation 0.73 |
Secondary
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c \> 9%. Among the 132 subjects with both baseline and end of study A1c, 32 had A1c \> 9%
Time frame: Baseline and 1 year after screening
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 530G Insulin Pump | Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups | -0.02 percentage | Standard Deviation 1.27 |