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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P160017 S031/ PAS001 |
| Date Original Protocol Accepted |
06/21/2018
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| Date Current Protocol Accepted |
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| Study Name |
Post-Approval Study
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| Device Name |
MiniMed 670G System
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent & Historical 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,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a multi-center, randomized, parallel, adaptive controlled trial in adult and pediatric patients with Type 1 Diabetes using Hybrid Closed Loop System (HCL) and/or control (CSII, MDI, or SAP) in the home setting. Three cohorts, each consisting of a control arm (CSII, MDI, or SAP) and an HCL arm and further divided by A1C group (A1C > 8% or A1C < 8%), will participate in the 6-month study period followed by a 6-month continuation period where all subjects will use HCL. The purpose of this study is to demonstrate the safety and effectiveness of the HCL in the study population. The device is investigational in subjects ages 2-6 years and non-investigational in subjects 7 years and up.
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| Study Population |
Adult and pediatric patients (2-80 years of age) with type 1 diabetes that meet the inclusion/exclusion criteria will be studied.
The device is investigational in ages 2-6 years. The 2-6 year age group is also being studied under an approved IDE.
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| Sample Size |
A minimum of 1120 subjects will be enrolled.
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| Key Study Endpoints |
Primary Safety Endpoint
The primary safety endpoint is the event rate of severe hypoglycemia and DKA from both A1C Groups (baseline A1C > 8% and baseline A1C < 8%) during the first 6 months of study phase and second 6 months of continuation phase. The descriptive summary statistics will be presented by number of event and event rate (100 patient years) for severe hypoglycemia and DKA separately.
The safety of the study will be evaluated and summarized per arm, including but not limited to the following:
• Diabetic ketoacidosis (DKA)
• Severe hypoglycemia
• Severe hyperglycemia
• Serious adverse events (SAEs)
• Unanticipated adverse device effects (UADEs)
Descriptive analyses will be performed to assess the primary safety endpoint. Event rates of severe hypoglycemia and DKA will be compared to: (1) the target event rate (defined by the medical literature and other studies) and (2) the control groups (CSII, MDI, SAP).
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| Follow-up Visits and Length of Follow-up |
Follow-up visits are scheduled throughout the study period up to 6 months and throughout the continuation period up to 6 months.
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