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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P120010 / PAS002 |
| Date Original Protocol Accepted |
10/11/2017
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| Date Current Protocol Accepted |
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| Study Name |
PAS of TS Feat w/sensor-aug w/comm data
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| Device Name |
MINIMED 530G SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Other Study Design
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| Data Source |
Sponsor Registry
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Analytical
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| Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of the study is to demonstrate that home use of the Medtronic MiniMed 530G System with utilization of the Threshold Suspend feature is not associated with glycemic deterioration. The objective will be demonstrated using two substudies.
Substudy 1: Multi Center Trial
This prospective, multi center, new enrollment study will compare measured baseline HbA1c to end of study (12 months) HbA1c, and will also summarize adverse events and provide results broken down by patient characteristics of interest.
Substudy 2: Commercial Data Evaluation
This retrospective cohort study of a real world data set will evaluate data from a subcohort of the CareLink commercial database of MiniMed 530G users to verify that use of the MiniMed 530G System is not associated with glycemic deterioration over time.
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| Study Population |
Substudy 1: Subjects aged 16 or older currently diagnosed with diabetes mellitus and having required insulin for over a period of one year.
Substudy 2: Subjects from the CareLink data set who have all of the following: demographic information, been followed through the Outreach program for at least one year, have two self reported HbA1c values at least 30 days apart, have uploaded device data via CareLink, and do not overlap with the new enrollment study cohort.
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| Sample Size |
Substudy 1: A total of 426 subjects have been enrolled. A total of 100 subjects is needed to test the hypothesis for this substudy.
Substudy 2: A total of 1402 subjects fit the inclusion criteria for the CareLink commercial analysis cohort. A sample size of 200 subjects is needed to test each prespecified hypothesis for this substudy.
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| Key Study Endpoints |
Substudy 1:
Primary Endpoint: Overall mean change in HbA1c from baseline to 12 month follow-up.
Secondary Endpoint: Overall mean change in HbA1c from baseline to 12 month follow-up stratified by baseline HbA1c measurement (less than 7 percent, 7 to 9 percent, greater than 9 percent).
Safety Endpoints: Serious Adverse events, Unanticipated Adverse Device Effects, Incidence of Severe Hypoglycemia, Incidence of Severe Hyperglycemia, Incidence of Diabetic Ketoacidosis.
Substudy 2:
Primary Endpoint: The difference between self reported first HbA1c and subsequent HbA1c.
Effectiveness Endpoints:
1. The difference in time spent with sensor glucose level less than 70 mg per dL with the Threshold Suspend Feature ON versus with the Threshold Suspend Feature OFF.
2. The difference in time spent with sensor glucose level greater than 180 mg per dL with the Threshold Suspend Feature ON versus with the Threshold Suspend Feature OFF.
Secondary Endpoints will include: reporting of adverse events collected through Medtronic’s Outreach program, stratifications of the primary and effectiveness endpoints by baseline patient characteristics, and other descriptive endpoints related to subjects’ utilization of the Threshold Suspend Feature and subjects’ adherence to CGM and adjunctive fingerstick glucose readings.
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| Follow-up Visits and Length of Follow-up |
Substudy 1: Follow-up will be 12 months.
Substudy 2: Follow-up was up to one year.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Multi-Center Study (Sub-study 1) – Approximately 82 percent of subjects who enrolled and were eligible to participate in this study completed the study.
Commercial Data Study (Sub-study 2) – 1316 device users were identified in the CareLink database that fit the criteria for analysis.
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| Actual Number of Sites Enrolled |
Multi-Center Study (Sub-study 1) – Approximately 82 percent of subjects who enrolled and were eligible to participate in this study completed the study.
Commercial Data Study (Sub-study 2) – Not Applicable.
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| Patient Follow-up Rate |
Multi-Center Study (Sub-study 1) – Approximately 82 percent of subjects who enrolled and were eligible to participate in this study completed the study.
Commercial Data Study (Sub-study 2) – Not applicable.
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| Final Safety Findings |
Multi-Center Study (Sub-study 1) – Three subjects died during the study, but their deaths were not attributable to the device. There were 79 Adverse Events or Serious Adverse Events reported during this study, four of the 27 Serious Adverse Events were device related. There were no Serious Unanticipated Adverse Events. Seven occurrences of severe hypoglycemia were reported. Fourteen severe hyperglycemia events were reported, and six diabetic ketoacidosis events were reported.
Commercial Data Study (Sub-study 2)—Not applicable.
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| Final Effect Findings |
Multi-Center Study (Sub-study 1) – The use of the MiniMed 530G System with the Threshold Suspend Feature was not associated with glycemic deterioration greater than 0.4 percent over a 12 month period in this study group. When stratified by baseline HbA1c, only the group of subjects who had HbA1c’s less than seven percent had a mean increase in HbA1c at 12 months.
Commercial Data Study (Sub-study 2) – The difference between (self-reported) HbA1c before MiniMed 530G use and follow-up (measured at least 30 days after start of first HbA1c) was reported as a decrease of 1.36 percent. Time spent in hypoglycemia or hyperglycemia (as determined by number of sensor readings) was lower with the Threshold Suspend feature On compared to Off in this cohort.
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| Study Strengths & Weaknesses |
This multi-part study provided evidence from a variety of sources (new enrollment and long-term follow-up, retrospective analysis of a commercial data set, and systematic literature review) that overall the use of the MiniMed 530G system with the Threshold Suspend feature activated is not associated with deterioration in glycemic control.
Multi-Center Study (Sub-study 1) – This study provided the first long-term (one year) safety and effectiveness results for a cohort of subjects utilizing a sensor augmented pump for management of diabetes. The follow-up rate in this analytical study was high enough to allow the hypothesis to be assessed without worry of substantial bias. The hypothesis-driven primary endpoint of the study was met and provided evidence that use of the Threshold Suspend feature does not result in glycemic deterioration. Additionally, the sponsor collected and reported detailed information on adverse events and device issues during the study duration. Lower than expected enrollment numbers forced a reduction in some of the aims of this study. Therefore, not all of the initially intended descriptive subgroup analyses were possible or meaningful.
Commercial Data Study (Sub-study 2) – This real world data set allowed for analyses to be conducted on a relatively large sample (n=1316) of MiniMed 530G users. The basic patient demographics (age and gender) were similar between this data set and the multi-center study. While the initial HbA1c entered by the user into the CareLink database was self-reported, all the users in this analysis had a subsequent HbA1c collected and reported through CareLink through Medtronic’s “StartRight” program.
This data set was not designed to address the safety and effectiveness questions outlined in the conditions of approval for this device. Follow-up of users through CareLink was not mandated by a study protocol prior to the collection of this commercial data, and detailed information on adverse events was not conducted through this database. Therefore, this data was not used to address questions regarding adverse events.
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| Recommendations for Labeling Changes |
Yes, the sponsor should update the labeling to reflect Final Post Approval Study Results.
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