LENNY Study
Research type
Research Study
Full title
EvaLuation of thE MiNiMed 780 System iN Young Paediatric Subjects (2-6 years old) with Type 1 Diabetes in a Home Setting (Lenny Study)
IRAS ID
316323
Contact name
Fiona Campbell
Contact email
Sponsor organisation
Medtronic
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This study is a pre-market, prospective, open-label, multi-center, randomized crossover trial in pediatric patients aged 2-6 years with type 1 diabetes. The purpose is to demonstrate the safety and performance of the MiniMed™ 780G system in a home setting. The study consists of a run-in phase, a study phase and a continuation phase. The purpose of the run-in phase is to train subject’s parent(s)/legal guardian(s) on the MiniMed 780G system and to collect 2 weeks of baseline data. At the end of the Run-in phase the subjects will be randomized in two sequences (A or B) and the Study Phase of 6-month will start. Subjects in Sequence A will firstly use the system in Auto Mode (3-month) and then in Manual Mode (3-month); Subjects in Sequence B will firstly use the system in Manual Mode (3-month) and then in Auto Mode (3-month). For the duration of the 6-month Continuation Phase all the subjects will use the system in Auto Mode. The system is composed by the Medtronic MiniMed™ 780G Insulin Pump, the Guardian™ 4 Sensor and the Guardian™ 4 Transmitter that are CE marked and are approved for use by the public for patients of ages 7 years and older. For this study, the study pump, sensor and transmitter will be used in the same manner in patients, in the age of 2-6 years old. For patients in the age of 2-6 years old, the study pump, sensor and transmitter are not CE marked and therefore will be considered investigational for this study. Approximately 100 subjects with type 1 diabetes age 2-6 years will be enrolled at up to 18 investigational centers across Europe.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
22/WM/0193
Date of REC Opinion
31 Oct 2022
REC opinion
Further Information Favourable Opinion