Clinical trial NCT05574062: Evaluation of the MiniMed 780 System in Paediatric Subjects
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type1
Children, Only
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2022-10-10
Enrollment: 101
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

1. Aged 2 - 6 years at time of screening
2. 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
3. Is on MDI therapy or CSII with or without CGM prior to screening
4. Has a glycosylated hemoglobin (HbA1c) \< 11% (97 mmol/mol) at time of screening visit as processed by a Local Lab
5. Is using or willing to switch to one of the following commercialized available insulins: Humalog (insulin lispro injection) and NovoLog (insulin aspart).
6. Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units
7. 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.
8. 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.
9. Investigator has confidence that the parent(s)/legal guardian(s) can successfully operate all study devices and is capable of adhering to the protocol
10. Subject and parent(s)/legal guardian(s) willingness to participate in all training sessions as directed by study staff.
11. Subject's parent/legal guardian must be willing and able to provide written informed consent.

Exclusion Criteria:

1. Has Addison's disease, growth hormone deficiency, coeliac disease, hypopituitarism or definite gastroparesis, untreated thyroid disorder, or poorly controlled asthma, per investigator judgment.
2. 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).
3. 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.
4. 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.
5. Has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
6. 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.
7. 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.
8. Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
9. History of \>1 DKA event not related to illness or initial diagnosis in the last 3 months.
10. Parent(s)/legal guardian(s) are part of research staff involved with the study.
11. Parent(s)/legal guardian(s) are illiterate

Primary outcomes:
measure: Study Phase Primary Endpoint: Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L])
timeFrame: 26 weeks
measure: Continuation Phase Primary Endpoint: mean in HbA1c
timeFrame: 12 weeks
Secondary outcomes:
measure: Study Phase Secondary Endpoint 1- Between-treatment difference in mean HbA1c
timeFrame: 26 weeks
measure: Study Phase Secondary Endpoint 2-Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L])
timeFrame: 26 weeks
measure: Study Phase Secondary Endpoint 3-Between-treatment difference in mean HbA1c
timeFrame: 26 weeks
measure: Continuation Phase Secondary Endpoint 1- Mean HbA1c
timeFrame: 12 weeks
measure: Continuation Phase Secondary Endpoint 2- Time spent in target range (70 to 180 mg/dL [3.9-10.0 mmol/L])
timeFrame: 12 weeks
measure: Continuation Phase Secondary Endpoint 3- Time spent in target range (70 to 180 mg/dL [3.9-10.0 mmol/L])
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: HUS
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Ancona
country: Italy
facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti Ancona, "G. Salesi"
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Luigi Vanvitelli
city: Novara
country: Italy
facility: Ospedale Maggiore della Carità di Novara
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana (UMCL)
city: Cardiff
country: United Kingdom
facility: Noah's Ark Children's Hospital for Wales
city: Leeds
country: United Kingdom
facility: LEEDS TEACHING HOSPITALS NHS TRUST - St James
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: UCLH (University College London Hospitals)
Study officials:
affiliation: Medtronic
name: Ohad Cohen, MD
role: STUDY_CHAIR
References: