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Diabetes type1LENNYNCT05574062

Evaluation of the MiniMed 780 System in Paediatric Subjects

A study testing MiniMed 780G Auto Mode with G4S sensor, MiniMed 780G Manual Mode with G4S sensor and MiniMed 780G Auto Mode with DS5 sensor in people with Diabetes type1 and Children, Only, run by Medtronic MiniMed, Inc. at 12 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 2 to 6 years
Conditions the study is for
Diabetes type1, Children, Only
What is being tested?
MiniMed 780G Auto Mode with G4S sensor, MiniMed 780G Manual Mode with G4S sensor and MiniMed 780G Auto Mode with DS5 sensor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
12 sitesin 4 countries
Study dates
24 Mar 2023to 15 Nov 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

12 sites in 4 countries.

12 sites in 4 countries

Italy4 sites

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

    Ancona

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli

    Naples

  • Ospedale Maggiore della Carità di Novara

    Novara

  • Ospedale Pediatrico Bambino Gesù

    Roma

Other trials in Italy

United Kingdom4 sites

  • Noah's Ark Children's Hospital for Wales

    Cardiff

  • LEEDS TEACHING HOSPITALS NHS TRUST - St James

    Leeds

  • Leicester Royal Infirmary

    Leicester

  • UCLH (University College London Hospitals)

    London

Other trials in United Kingdom

Finland3 sites

  • HUS

    Espoo

  • Tampere University Hospital

    Tampere

  • Turku University Hospital

    Turku

Other trials in Finland

Slovenia1 site

  • University Medical Center Ljubljana (UMCL)

    Ljubljana

Other trials in Slovenia

About this study

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

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).

Read the 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.

Being tested
MiniMed 780G Auto Mode with G4S sensor, MiniMed 780G Manual Mode with G4S sensor, MiniMed 780G Auto Mode with DS5 sensor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MiniMed 780G Auto Mode with G4S sensorDevice

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

  • MiniMed 780G Manual Mode with G4S sensorDevice

    MiniMed™ 780G system in Manual Mode.

  • MiniMed 780G Auto Mode with DS5 sensorDevice

    MiniMed 780G Auto Mode with DS5 sensor

Study groups in NCT05574062
Study groupRoleWhat they receive
All subjectsOtherAll 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
Receives: Device: MiniMed 780G Auto Mode with G4S sensor; Device: MiniMed 780G Manual Mode with G4S sensor
Study phase - Sequence AExperimentalSubjects 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).
Receives: Device: MiniMed 780G Auto Mode with G4S sensor; Device: MiniMed 780G Manual Mode with G4S sensor
Study phase - Sequence BExperimentalSubjects 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).
Receives: Device: MiniMed 780G Auto Mode with G4S sensor; Device: MiniMed 780G Manual Mode with G4S sensor
Continuation Phase - Arm A2ExperimentalSubjects will start using the MiniMed™ 780G BLE 2.0 system in Auto Mode with the DS5 sensor
Receives: Device: MiniMed 780G Auto Mode with DS5 sensor
Continuation Phase - Arm B2Active comparatorSubjects will continue to use MiniMed™ 780G system in Auto Mode with G4S sensor for 12 weeks
Receives: Device: MiniMed 780G Auto Mode with G4S sensor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks for each cross-over period

  2. 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.

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

Secondary outcomes (6)

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

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

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

  2. Study Phase Secondary Endpoint 2 - Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Superiority Test

    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.

    Measured: 12 weeks for each cross-over period

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

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

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

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

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

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

  5. 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

    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

    Measured: 12 weeks of continuation phase period 2

  6. Continuation Phase Secondary Endpoint 3- Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Superiority Test

    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.

    Measured: 12 weeks of continuation phase period 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2022
  2. Study start24 Mar 2023
  3. Primary completion22 Apr 2024
  4. Study completion15 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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).
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05574062
Sponsor's protocol ID
CIP342
Acronym
LENNY
Status last verified
Apr 2025
First submitted
22 Sep 2022
Last updated
19 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 40544853

Questions about this trial

What is this clinical trial studying?

A study testing MiniMed 780G Auto Mode with G4S sensor, MiniMed 780G Manual Mode with G4S sensor and MiniMed 780G Auto Mode with DS5 sensor in people with Diabetes type1 and Children, Only, run by Medtronic MiniMed, Inc. at 12 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Italy, United Kingdom, Finland, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Phase Primary Endpoint: Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Non-inferiority Test (time frame: 12 weeks for each cross-over period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05574062, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.

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