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
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.Summary of Results:
The results confirmed that the use of the MiniMed 780G system in Auto Mode in paediatric subjects (2-6 years old) is safe and effective.
At 6-month (primary endpoint of the study phase) the percentage of time in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L), during the period in the Treatment with MiniMed™ 780G in Auto Mode was higher [68.34 (±6.92) %] compared to Control with MiniMed™ 780G in Manual Mode + SBL [58.34 (± 12.45) %]; with an adjusted between-treatment difference of 9.9% (p <0.0001). An improvement in the HbA1c was also noticed during the period in the Treatment with MiniMed™ 780G in Auto Mode [7.00 ± 0.53% (53.01 ± 5.82 mmol/L) ] compared to Control with MiniMed™ 780G in Manual Mode + SBL [7.61 ± 0.90% (59.72 ± 9.90 mmol/L)] with an adjusted between-treatment difference of -0.61% (p <0.0001). Overall, during the study phase, 9 serious adverse events were reported and assessed as not device related. Among these, one event of diabetic ketoacidosis (DKA ) was reported, event occurred when the subject was using the system in auto mode and was classified as not device related. There were no reports of unanticipated serious adverse device effects ( USADEs) or Severe Hypoglycaemia.
At 12-month (primary endpoint of the continuation phase) no differences in HbA1c value were observed between subjects using the MiniMed™ 780G system in Auto Mode [7.24 ± 0.64 % (55.59 ± 7.03 mmol/L)] and subjects using MiniMed™ 780G BLE 2.0 system with DS5 sensor in Auto Mode [7.30 ± 0.53 (56.32 ± 5.79 mmol/L)] with an adjusted between treatment difference of 0.14 %. Similarly, the percentage of time in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L), for subjects using the MiniMed™ 780G BLE 2.0 system with DS5 sensor in Auto Mode (69.66 ± 7.73 %) was similar to the percentage observed on subject using the MiniMed™ 780G system in Auto Mode (68.86 ± 8.61 %), with an adjusted between treatment difference. Overall, during the continuation phase, 7 serious adverse events were reported and assessed as not device related. Among these events one death was reported, following meningoencephalitis, the event was classified as not device related. Two episodes of Severe Hypoglycaemia were reported in one subject, both the events were classified as not serious and not device related. There were no reports of USADEs or DKA.
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