NCT05574062

Evaluation of the MiniMed 780 System in Paediatric Subjects

Evaluation of the MiniMed 780 System in Young Paediatric Subjects (2-6 Years Old) With Type 1 Diabetes in a Home Setting (LENNY)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Diabetes type1
• Children, Only

Interventions

Type	Name	Description
DEVICE	MiniMed 780G Auto Mode with G4S sensor	MiniMed™ 780G system in Auto Mode with G4S sensor.
DEVICE	MiniMed 780G Manual Mode with G4S sensor	MiniMed™ 780G system in Manual Mode.
DEVICE	MiniMed 780G Auto Mode with DS5 sensor	MiniMed 780G Auto Mode with DS5 sensor

Timeline

• Start date: 2023-03-24
• Primary completion: 2024-04-22
• Completion: 2024-11-15
• First posted: 2022-10-10
• Last updated: 2025-06-19
• Results posted: 2025-06-19

Locations

12 sites across 4 countries: Finland, Italy, Slovenia, United Kingdom

Regulatory

• FDA-regulated device study