The purpose of this study is to demonstrate the safety and performance of the MiniMed™ 780G system in pediatric subjects (2-6 years old) with type 1 diabetes in a home setting. The objective of this study is to evaluate the safety and performance of the MiniMed™ 780G system in Auto Mode firstly in comparison to the MiniMed™ 780G system in Manual Mode with Suspend before low activated (currently available standard therapy) and secondly in comparison to the new MiniMed™ 780G BLE 2.0 system with DS5 sensor in Auto Mode among pediatric population (2-6 years old).
CIP342 study is a pre-market, prospective, open-label, multi-center, randomized crossover trial in paediatric subjects (2-6 years old) with type 1 diabetes. The study consists of a run-in phase, a study phase and a continuation phase. Run-in Phase: The purpose of the run-in phase (2 to 4 weeks) is to train subject's parent(s)/legal guardian(s) on the MiniMed 780G system in Manual Mode with Suspend before low (SBL) activated and to collect 2 weeks of baseline data. At the end of Run-in Phase, subjects will be randomized into one of two sequences (A or B). The MiniMed 780G system is composed by the MiniMed 780G pump used with Guardian 4 Sensor (G4S) and Guardian Transmitter 4. Study Phase: * Sequence A: subjects will use the Advanced Hybrid Closed Loop (AHCL) therapy (MiniMed 780G system in Auto Mode) for 12 weeks (Treatment). The washout phase of 2 weeks will be followed by a 12-week phase where subjects will use predictive low-glucose suspend (780G system in Manual Mode with SBL activated) (Control). * Sequence B: subjects will continue to use predictive low-glucose suspend (MiniMed 780G system in Manual Mode with SBL activated) (Control). After a washout phase of 2 weeks, subjects will use Advanced Hybrid Closed Loop (AHCL) therapy (MiniMed 780G system in Auto Mode) for 12 weeks (Treatment). During washout period all the subjects will use MiniMed 780G system in Manual Mode with SBL activated. At the end of Study Phase, subjects will start Continuation Phase that is divided in two periods. Continuation Phase: * Period 1: enrolled subjects will enter the continuation phase period 1 and will use MiniMed 780G system in Auto Mode for 18 weeks +/- 6 weeks. * Period 2: At the end of the continuation phase period 1, subjects will be randomized into 2 arms (A2 and B2). This second randomization is completely independent from the first one in the Study Phase. Arm A2: Subjects will start using the MiniMed 780G BLE 2.0 system (treatment) for 12 weeks. The MiniMed 780G BLE 2.0 system is composed by the MiniMed 780 BLE 2.0 and Disposable Sensor labeled (DS5) Arm B2: Subjects will continue to use MiniMed™ 780G system in Auto Mode for 12 weeks.
Study Type
MiniMed™ 780G system in Auto Mode with G4S sensor.
MiniMed™ 780G system in Manual Mode.
MiniMed 780G Auto Mode with DS5 sensor
HUS
Espoo, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Study Phase Primary Endpoint: Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Non-inferiority Test
The primary endpoint is the between-treatment difference in the percentage of time that the sensor glucose measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L), non-inferiority test.
Time frame: 12 weeks for each cross-over period
Continuation Phase Primary Endpoint: Mean HbA1c (%) - Non-inferiority Test
The primary endpoint for continuation phase is the between-treatment difference in the mean HbA1c (%) at the end of 12-week continuation phase period 2. The endpoint will be assessed for non-inferiority with an absolute margin of 0.4% HbA1c.
Time frame: The outcome was measured at the end of the 12-week continuation phase period 2
Study Phase Secondary Endpoint 1- Mean HbA1c (%) - Non-inferiority Test
Between-treatment difference in mean HbA1c at the end of each 12-week cross-over period, non-inferiority test.
Time frame: The outcome was measured at the end of each 12 week cross-over period
Study Phase Secondary Endpoint 2 - Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Superiority Test
Between-treatment difference in % Time spent in target range (70 to 180 mg/dL \[3.9-10.0 mmol/L\]), during each 12 week cross-over period, superiority test.
Time frame: 12 weeks for each cross-over period
Study Phase Secondary Endpoint 3 - Mean HbA1c (%) - Superiority Test.
Between-treatment difference in mean HbA1c at the end of each 12-week cross-over period, superiority test.
Time frame: The outcome was measured at the end of each 12 week cross-over period
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INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Azienda Ospedaliero-Universitaria Ospedali Riuniti Ancona, "G. Salesi"
Ancona, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, Italy
Ospedale Maggiore della Carità di Novara
Novara, Italy
Ospedale Pediatrico Bambino Gesù
Roma, Italy
University Medical Center Ljubljana (UMCL)
Ljubljana, Slovenia
Noah's Ark Children's Hospital for Wales
Cardiff, United Kingdom
LEEDS TEACHING HOSPITALS NHS TRUST - St James
Leeds, United Kingdom
...and 2 more locations
Continuation Phase Secondary Endpoint 1- Mean HbA1c (%) - Superiority Test
Between-treatment difference in Mean HbA1c at the end of the 12-week continuation phase period 2, superiority test.
Time frame: The outcome was measured at the end of the 12-week continuation phase period 2
Continuation Phase Secondary Endpoint 2- Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Non-inferiority Test
Between-treatment difference in % Time spent in target range (70 to 180 mg/dL \[3.9-10.0 mmol/L\]) during the end 12-week continuation phase period 2, non-inferiority test
Time frame: 12 weeks of continuation phase period 2
Continuation Phase Secondary Endpoint 3- Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Superiority Test
Between-treatment difference in % Time spent in target range (70 to 180 mg/dL \[3.9-10.0 mmol/L\]) during the end 12-week continuation phase period 2, superiority test.
Time frame: 12 weeks of continuation phase period 2