Who is sponsoring NCT05574062?

NCT05574062 is sponsored by Medtronic MiniMed, Inc..

What drugs are being tested in NCT05574062?

Interventions in NCT05574062: MiniMed 780G Auto Mode with G4S sensor, MiniMed 780G Manual Mode with G4S sensor, MiniMed 780G Auto Mode with DS5 sensor.

What condition does NCT05574062 study?

NCT05574062 studies Diabetes type1, Children, Only.

Is NCT05574062 still recruiting?

NCT05574062 is currently completed. Last updated 19 June 2025.

Are results published for NCT05574062?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-06-19 · How we verify

NCT05574062: LENNY

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of the MiniMed 780 System in Paediatric Subjects

Completed NA Results posted Last updated 19 June 2025

What this trial tests

NA trial testing MiniMed 780G Auto Mode with G4S sensor in Diabetes type1 in 101 participants. Completed in 15 November 2024.

Timeline

24 March 2023

Primary endpoint
22 April 2024

15 November 2024

Quick facts

Lead sponsor	Medtronic MiniMed, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	101
Start date	24 March 2023
Primary completion	22 April 2024
Estimated completion	15 November 2024
Sites	12 locations across Italy, Finland, Slovenia, United Kingdom

Drugs / interventions tested

MiniMed 780G Auto Mode with G4S sensor
MiniMed 780G Manual Mode with G4S sensor
MiniMed 780G Auto Mode with DS5 sensor

Conditions studied

Diabetes type1 — all drugs for Diabetes type1 →
Children, Only — all drugs for Children, Only →

Sponsor

Medtronic MiniMed, Inc.

Who can join

Adults 2 to 6, any sex, with Diabetes type1 or Children, Only. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Study Phase Primary Endpoint: Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Non-inferiority Test Primary · 12 weeks for each cross-over period

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.

Group	Value	95% CI
MiniMed 780G (With G4S Sensor) System in Auto Mode	68.34	± 6.922
MiniMed 780G (With G4S Sensor) System in Manual Mode + SBL	58.34	± 12.455

Continuation Phase Primary Endpoint: Mean HbA1c (%) - Non-inferiority Test Primary · The outcome was measured at the end of the 12-week continuation phase period 2

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.

Group	Value	95% CI
MiniMed™ 780G System in Auto Mode With the DS5 Sensor	7.30	± 0.529
MiniMed™ 780G System in Auto Mode With the G4S Sensor	7.24	± 0.643

Study Phase Secondary Endpoint 1- Mean HbA1c (%) - Non-inferiority Test Secondary · The outcome was measured at the end of each 12 week cross-over period

Between-treatment difference in mean HbA1c at the end of each 12-week cross-over period, non-inferiority test.

Group	Value	95% CI
MiniMed 780G (With G4S Sensor) System in Auto Mode	7.00	± 0.533
MiniMed 78G (With G4S Sensor) System in Manual Mode + SBL	7.61	± 0.906

Study Phase Secondary Endpoint 2 - Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Superiority Test Secondary · 12 weeks for each cross-over period

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.

Group	Value	95% CI
MiniMed 780G (With G4S Sensor) System in Auto Mode	68.34	± 6.922
MiniMed 78G (With G4S Sensor) System in Manual Mode + SBL	58.34	± 12.455

Study Phase Secondary Endpoint 3 - Mean HbA1c (%) - Superiority Test. Secondary · The outcome was measured at the end of each 12 week cross-over period

Between-treatment difference in mean HbA1c at the end of each 12-week cross-over period, superiority test.

Group	Value	95% CI
MiniMed 780G (With G4S Sensor) System in Auto Mode	7.00	± 0.533
MiniMed 78G (With G4S Sensor) System in Manual Mode + SBL	7.61	± 0.906

Continuation Phase Secondary Endpoint 1- Mean HbA1c (%) - Superiority Test Secondary · The outcome was measured at the end of the 12-week continuation phase period 2

Between-treatment difference in Mean HbA1c at the end of the 12-week continuation phase period 2, superiority test.

Group	Value	95% CI
MiniMed™ 780G System in Auto Mode With the DS5 Sensor	7.30	± 0.529
MiniMed™ 780G System in Auto Mode With the G4S	7.24	± 0.643

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 Secondary · 12 weeks of continuation phase period 2

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

Group	Value	95% CI
MiniMed™ 780G System in Auto Mode With the DS5 Sensor	69.7	± 7.728
MiniMed™ 780G System in Auto Mode With the G4S	68.8	± 8.615

Continuation Phase Secondary Endpoint 3- Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Superiority Test Secondary · 12 weeks of continuation phase period 2

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.

Group	Value	95% CI
MiniMed™ 780G System in Auto Mode With the DS5 Sensor	69.66	± 7.734
MiniMed™ 780G System in Auto Mode With the G4S	68.86	± 8.615

Adverse events — posted to ClinicalTrials.gov

Time frame: AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Run-In Period

Serious: 1/98 (1%)

Deaths: 0/98

MiniMed 780G (With G4S Sensor) System in Auto Mode - Study Phase

Serious: 5/98 (5%)

Deaths: 0/98

Wash-out Period

Serious: 1/97 (1%)

Deaths: 0/97

MiniMed 780G (With G4S Sensor) System in Manual Mode + SBL - Study Phase

Serious: 2/97 (2%)

Deaths: 0/97

Continuation Phase Period 1

Serious: 4/95 (4%)

Deaths: 1/95

MiniMed 780G (With DS5 Sensor) System in Auto Mode - Continuation Phase Period 2

Serious: 1/45 (2%)

Deaths: 0/45

MiniMed 780G (With G4S Sensor) System in Auto Mode - Continuation Phase Period 2

Serious: 2/46 (4%)

Deaths: 0/46

Serious adverse events (13 terms)

Reaction	System	Run-In Period	MiniMed 780G (With G4S Sen…	Wash-out Period	MiniMed 780G (With G4S Sen…	Continuation Phase Period 1	MiniMed 780G (With DS5 Sen…	MiniMed 780G (With G4S Sen…
Left tibia fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
DKA	Metabolism and nutrition disorders	—	—	—	—	—	—	—
ACUTE BRONCHITIS	Infections and infestations	—	—	—	—	—	—	—
Upper respiratory infection	Infections and infestations	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—
Viral Induced Wheeze	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Scarlet Fever	Infections and infestations	—	—	—	—	—	—	—
Lower Respiratory Infection	Infections and infestations	—	—	—	—	—	—	—
Varicella infection with secondary supra-infection	Infections and infestations	—	—	—	—	—	—	—
ALLERGIC REACTION TO AMOXICILLIN SUSP	Immune system disorders	—	—	—	—	—	—	—
Reactive airway disease	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
MENINGOENCEPHALI TIS	Infections and infestations	—	—	—	—	—	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Run-In Period	MiniMed 780G (With G4S Sen…	Wash-out Period	MiniMed 780G (With G4S Sen…	Continuation Phase Period 1	MiniMed 780G (With DS5 Sen…	MiniMed 780G (With G4S Sen…
Infections and infestations	Infections and infestations	—	—	—	—	—	—	—
General disorders and administration site conditions	General disorders	—	—	—	—	—	—	—
Gastrointestinal disorders	Gastrointestinal disorders	—	—	—	—	—	—	—
Respiratory, thoracic and mediastinal disorders	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—

Most-reported serious reactions: Left tibia fracture, DKA, ACUTE BRONCHITIS, Upper respiratory infection, Gastroenteritis, Viral Induced Wheeze, Scarlet Fever, Lower Respiratory Infection.

Data from ClinicalTrials.gov NCT05574062 adverse events section.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and safety of automated insulin delivery in children aged 2-6 years (LENNY): an open-label, multicentre, randomised, crossover trial.
Battelino T, Kuusela S, Shetty A, Rabbone I, et al · · 2025 · cited 6× · PMID 40544853 · DOI 10.1016/s2213-8587(25)00091-9
Consistent efficacy and safety of automated insulin delivery in children aged 2-6 years: results from the LENNY trial continuation phase.
Dovc K, Tuomaala A, Kuusela S, Shetty A, et al · · 2025 · PMID 41075987 · DOI 10.1016/j.diabres.2025.112934

Verify or expand the search:

Other recruiting trials for Diabetes type1

Currently open trials in the same condition.

NCT06405373 — Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART · NA · recruiting
NCT06411210 — Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment · Phase 2 · recruiting
NCT06460558 — T1D Closed-loop and Physical Activity · recruiting
NCT06190756 — Impact of Gravity on Cardiac Hemodynamics · NA · recruiting

Other Medtronic MiniMed, Inc. trials

Trials by the same sponsor.

NCT07401901 — Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) · NA · not yet recruiting
NCT07227805 — Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in · NA · not yet recruiting
NCT06645834 — Smart MDI Study (CIP343) · NA · completed
NCT06604871 — Safety Evaluation of MiniMed™ 780G System With DS5 CGM in Children · NA · completed
NCT05029271 — InPen User Experience · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05574062 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medtronic MiniMed, Inc.
Last refreshed: 19 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05574062.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing