Evaluation of the MiniMed 780 System in Paediatric Subjects

NCT05574062 | Completed Results DMC FDA Device

• 1 other identifier: CIP342
• Study Type: interventional
• Target: 101
• Locations: 4 countries
• Sites: 12

Brief 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).

Conditions

Diabetes type1; Children, Only

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  The outcome was measured at the end of the 12-week continuation phase period 2

Secondary Outcomes (6)

• Study Phase Secondary Endpoint 1- Mean HbA1c (%) - Non-inferiority Test

  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

  12 weeks for each cross-over period

• Study Phase Secondary Endpoint 3 - Mean HbA1c (%) - Superiority Test.

  The outcome was measured at the end of each 12 week cross-over period

• Continuation Phase Secondary Endpoint 1- Mean HbA1c (%) - Superiority Test

  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

  12 weeks of continuation phase period 2

Study Arms (5)

All subjects

OTHER

All subjects used the MiniMed 780G (with G4S sensor) system in Manual Mode for 2 weeks during the run-in phase and used the MiniMed™ 780G system in Auto Mode for 18 weeks during the continuation phase period 1

Device: MiniMed 780G Auto Mode with G4S sensor; Device: MiniMed 780G Manual Mode with G4S sensor

Study phase - Sequence A

EXPERIMENTAL

Subjects used the MiniMed 780G (with G4S sensor) system in Auto Mode for 12 weeks (Treatment), followed by 2 weeks of washout period where the system was used in Manual Mode with SBL activated (Control). After the washout period the subjects used the MiniMed 780G (with G4S sensor) system in Manual Mode with SBL activated (Control).

Device: MiniMed 780G Auto Mode with G4S sensor; Device: MiniMed 780G Manual Mode with G4S sensor

Study phase - Sequence B

EXPERIMENTAL

Subjects used the MiniMed 780G (with G4S sensor) system in Manual Mode with SBL activated for 12 weeks (Control), followed by 2 weeks of washout period where the system was used in Manual Mode with SBL activated (Control). After the washout period the subjects used the MiniMed 780G (with G4S sensor) system in Auto Mode (Treatment).

Device: MiniMed 780G Auto Mode with G4S sensor; Device: MiniMed 780G Manual Mode with G4S sensor

Continuation Phase - Arm A2

EXPERIMENTAL

Subjects will start using the MiniMed™ 780G BLE 2.0 system in Auto Mode with the DS5 sensor

Device: MiniMed 780G Auto Mode with DS5 sensor

Continuation Phase - Arm B2

ACTIVE COMPARATOR

Subjects will continue to use MiniMed™ 780G system in Auto Mode with G4S sensor for 12 weeks

Device: MiniMed 780G Auto Mode with G4S sensor

Interventions

MiniMed 780G Auto Mode with G4S sensor DEVICE

MiniMed™ 780G system in Auto Mode with G4S sensor.

All subjects; Continuation Phase - Arm B2; Study phase - Sequence A; Study phase - Sequence B

MiniMed 780G Manual Mode with G4S sensor DEVICE

MiniMed™ 780G system in Manual Mode.

All subjects; Study phase - Sequence A; Study phase - Sequence B

MiniMed 780G Auto Mode with DS5 sensor DEVICE

MiniMed 780G Auto Mode with DS5 sensor

Continuation Phase - Arm A2

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 2 - 6 years at time of screening
• Has a clinical diagnosis of type 1 diabetes for ≥ 6 months prior to screening as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
• Is on MDI therapy or CSII with or without CGM prior to screening
• Has a glycosylated hemoglobin (HbA1c) \< 11% (97 mmol/mol) at time of screening visit as processed by a Local Lab
• Is using or willing to switch to one of the following commercialized available insulins: Humalog (insulin lispro injection) and NovoLog (insulin aspart).
• Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units
• Parent(s)/legal guardian(s) willing to upload data from the pump system, must have Internet access, a compatible computer or mobile phone that meets the requirements for uploading the study pump data at home.
• Is living with one or more parent(s)/legal guardian(s) knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.
• Investigator has confidence that the parent(s)/legal guardian(s) can successfully operate all study devices and is capable of adhering to the protocol
• Subject and parent(s)/legal guardian(s) willingness to participate in all training sessions as directed by study staff.
• Subject's parent/legal guardian must be willing and able to provide written informed consent.

You may not qualify if:

• Has Addison's disease, growth hormone deficiency, coeliac disease, hypopituitarism or definite gastroparesis, untreated thyroid disorder, or poorly controlled asthma, per investigator judgment.
• Is using any anti-diabetic medication other than insulin at the time of screening or plan of using during the study (e.g. pramlintide, DPP-4 inhibitor, GLP-1, agonists/mimetics, metformin, SGLT2 inhibitors).
• Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.
• Has had renal failure defined by creatinine clearance \<30 ml/min, as assessed by local lab test ≤6 months before screening or performed at screening at local lab, as defined by the creatinine-based Cockcroft, CKD-EPI or MDRD equations.
• Has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• Is under Control IQ or CamAPS FX or other advanced hybrid closed loop therapy (e.g. DIY, MiniMed 780G) in the previous 3 months before enrollment. Note: For the continuation phase only, subjects using MiniMed 780G can be enrolled.
• Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study, as per investigator judgment.
• Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
• History of \>1 DKA event not related to illness or initial diagnosis in the last 3 months.
• Parent(s)/legal guardian(s) are part of research staff involved with the study.
• Parent(s)/legal guardian(s) are illiterate

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (12)

HUS

Espoo, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Azienda Ospedaliero-Universitaria Ospedali Riuniti Ancona, "G. Salesi"

Ancona, Italy

Location

Azienda Ospedaliera Universitaria Luigi Vanvitelli

Napoli, Italy

Location

Ospedale Maggiore della Carità di Novara

Novara, Italy

Location

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Location

University Medical Center Ljubljana (UMCL)

Ljubljana, Slovenia

Location

Noah's Ark Children's Hospital for Wales

Cardiff, United Kingdom

Location

LEEDS TEACHING HOSPITALS NHS TRUST - St James

Leeds, United Kingdom

Location

Leicester Royal Infirmary

Leicester, United Kingdom

Location

UCLH (University College London Hospitals)

London, United Kingdom

Location

Related Publications (1)

• Battelino T, Kuusela S, Shetty A, Rabbone I, Cherubini V, Campbell F, Ahomaki R, Tuomaala AK, Peters C, Iafusco D, Sundaram P, Schiaffini R, Cellot J, Gulotta F, Di Piazza F, Cohen O; LENNY study group. Efficacy and safety of automated insulin delivery in children aged 2-6 years (LENNY): an open-label, multicentre, randomised, crossover trial. Lancet Diabetes Endocrinol. 2025 Aug;13(8):662-673. doi: 10.1016/S2213-8587(25)00091-9. Epub 2025 Jun 19.

  PMID: 40544853 DERIVED

Results Point of Contact

• Title: Fabio Di Piazza
• Organization: MedtronicD

fabio.di.piazza@medtronic.com

+393456172157

Study Officials

• Ohad Cohen, MD

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Run-in Phase: training on the MiniMed 780G system in Manual Mode with SBL activated to collect 2 weeks of baseline data. Study Phase: Sequence A: subjects 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 780G system in Manual Mode with SBL activated (Control). Sequence B: subjects 780G system in Manual Mode with SBL activated (Control). After a washout phase of 2 weeks, subjects will use t MiniMed 780G system in Auto Mode for 12 weeks (Treatment). Continuation Phase: Period 1: subjects will use MiniMed 780G system in Auto Mode for 18 weeks +/- 6 weeks. Period 2: Arm A2: subjects will start using the MiniMed 780G BLE 2.0 system (treatment) for 12 weeks (Treatment). Arm B2: subjects will continue to use MiniMed™ 780G system in Auto Mode for 12 weeks (Control).

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 10, 2022
• Study Start: March 24, 2023
• Primary Completion: April 22, 2024
• Study Completion: November 15, 2024
• Last Updated: June 19, 2025
• Results First Posted: June 19, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3); SL (1); GB (4); IT (4)