The purpose of the study is to evaluate the safety and the effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery system, named MiniMed NMX8 system (referred also to as NMX8 system), in comparison with other commercially available AID systems (Automated insulin delivery) in adult patients with Type 1 diabetes not achieving target clinical outcomes.
ELEVATE is a pre-market, interventional, prospective, open-label, multi-center, randomized controlled study that consists of three phases: run-in, study and continuation phase. Run-in: the purpose of this phase is to collect 3 weeks of blinded Continuous Glucose Monitoring (CGM) data while subjects are on their current therapy (baseline assessment). All subjects will use an additional blinded Simplera Sensor to collect blinded CGM data. Study Phase: during the 6-month of study phase subjects will either start using the NMX8 system (Treatment arm) or will continue to use their current AID therapy (Control arm). Subjects in the Control arm will undergo 3 weeks of blinded CGM data collection via Simplera Sensor at 3 and 6 months. Continuation Phase: during the 3-month of continuation phase all subjects will use the NMX8 system. Approximately 230 subjects will be enrolled in the study up to approximately 22 investigational centers in EMEA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
Subjects start using the NMX8 system after the run-in phase and continue through both study (6-month) and continuation phases (3-month).
Subjects will continue to use their current AID therapy during the study phase (6-month).
Subjects start using the NMX8 system during the continuation phases (3-month).
Centre Hospitalier Universitaire de Caen
Caen, France
Hôpital Michallon - CHU Grenoble
Primary Endpoint
The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in the percentage of time that the sensor glucose (SG) measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L) at the end of the study phase . The endpoint will be assessed for non-inferiority.
Time frame: End of 6-month study phase
Secondary Endpoint 1
The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in HbA1c (%) at the end of the study phase. The endpoint will be assessed for non-inferiority.
Time frame: End of 6-month study phase.
Secondary Endpoint 2
The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in HbA1c (%) at the end of the study phase. The endpoint will be assessed for superiority.
Time frame: End of 6-month study phase.
Secondary Endpoints 3
The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in the percentage of time spent in target range 70 to 180 mg/dL (3.9-10.0 mmol/L) at the end of the study phase. The Endpoint will be assessed for superiority.
Time frame: End of 6-month study phase.
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Grenoble, France
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...and 11 more locations