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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P160017 S091/ PAS001 |
| Date Original Protocol Accepted |
06/15/2023
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| Date Current Protocol Accepted |
|
| Study Name |
MiniMed 780G New Enrollment Study
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| Device Name |
MiniMed 780G System
|
| General Study Protocol Parameters |
| Study Design |
Active Surveillance
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of this program is to collect additional confirmatory information regarding the safety of the MiniMed™ 780G system following FDA approval and commercial launch of the system in the United States.
Information collected will include insulin delivery and continuous glucose monitoring (CGM) metrics information based on data uploaded from the pump, as well as adverse events, device deficiencies and HbA1C levels reported by the pump user or their parent or guardian
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| Study Population |
Individuals, ages 7 and older, who reside in the United States and who are using the MiniMed 780G pump.
Final analysis will consist of two populations: one population will include all participants who provide data; the other population will include only participants who completed at least 75% of surveys and who completed at least one of the two surveys for the twelfth month, and only these participants will count towards the 2,000-participant target.
Non-responders are defined as a participant who misses 2 consecutive surveys. Non-responder’s data will not be analyzed.
Automated Insulin Dosing (AID) system naïve users are defined as a user with no prior experience on any AID system.
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| Sample Size |
Total number of subjects: N = 2,000
Ages 7 – 13: N = 300, with N = 150 AID naïve
Ages 14 – 17: N = 300, with N = 150 AID naïve
Ages 18+: N = 500, with N = 125 AID naïve and N = 125 AID and CGM naïve
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| Key Study Endpoints |
Safety Endpoints
• Adverse events collected via biweekly surveys and/or Technical Support
• Evaluation of participants with significant total daily dose of insulin change and its association with Time In Range (TIR), Time Below Range (TBR) and reported Adverse Events (AEs)
• Evaluation of participants exhibiting Time Below Range (< 54 mg/dL) and Time Above Range (> 250 mg/dL) outside of current American Diabetes Association (ADA) guidelines of greater than 1% time below 54 mg/dL and/or greater than 5% time above 250 mg/dL
• Evaluation of Changes in medication associated with adverse events reported
• Number of participants with Auto Mode exits associated with adverse events reported
Effectiveness Endpoints
• Pump system use (insulin delivery & sensor use)
• Time spent in Auto Mode versus time spent in Manual Mode
• Sensor glucose: mean, standard deviation (SD) and coefficient of variation (CV)
• Time in Range (% of sensor glucose (SG)): 70 – 180 mg/dL
• Time in Hypoglycemic ranges (% of SG): SG < 54, <70 mg/dL
• Time in Hyperglycemic ranges (% of SG): SG > 180, >250 mg/dL, >350 mg/dL
• Change of Total Daily Dose (TDD) of insulin
• Summary of reported hemoglobin HbA1c
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