Evaluation of the MiniMed 780 System in Paediatric Subjects (LENNY)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes type1; Children, Only
• Intervention / Treatment: Device: Study Phase: MiniMed 780G Auto Mode with G4S sensor; Device: Continuation phase: MiniMed 780G BLE 2.0 with DS5 sensor; Device: Study Phase: MiniMed 780G Manual Mode with G4S sensor; Device: Continuation Phase MiniMed 780G Auto Mode with G4S sensor

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland
    • HUS
  • Tampere, Finland
    • Tampere University Hospital
  • Turku, Finland
    • Turku University Hospital
• Italy
  • Ancona, Italy
    • Azienda Ospedaliero-Universitaria Ospedali Riuniti Ancona, "G. Salesi"
  • Napoli, Italy
    • Azienda Ospedaliera Universitaria Luigi Vanvitelli
  • Novara, Italy
    • Ospedale Maggiore della Carità di Novara
  • Roma, Italy
    • Ospedale Pediatrico Bambino Gesù
• Slovenia
  • Ljubljana, Slovenia
    • University Medical Center Ljubljana (UMCL)
• United Kingdom
  • Cardiff, United Kingdom
    • Noah's Ark Children's Hospital for Wales
  • Leeds, United Kingdom
    • LEEDS TEACHING HOSPITALS NHS TRUST - St James
  • Leicester, United Kingdom
    • Leicester Royal Infirmary
  • London, United Kingdom
    • UCLH (University College London Hospitals)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; AHCL therapy (780G system in Auto Mode with G4S sensor in the study phase and 780G BLE 2.0 system in Auto Mode with DS5 sensor in the continuation phase)	Device: Study Phase: MiniMed 780G Auto Mode with G4S sensor; Subjects will start using the MiniMed™ 780G system in Auto Mode with G4S sensor.; Device: Continuation phase: MiniMed 780G BLE 2.0 with DS5 sensor; Subjects will start using the MiniMed 780G BLE 2.0 with DS5 sensor
Active Comparator: Control Arm; Predictive low-glucose suspend (780G system in Manual Mode with G4S sensor) in the study phase and AHCL therapy (780G system in Auto Mode with G4S sensor) in the continuation phase	Device: Study Phase: MiniMed 780G Manual Mode with G4S sensor; Subjects will start using the MiniMed™ 780G system in Manual Mode.; Device: Continuation Phase MiniMed 780G Auto Mode with G4S sensor; Subjects will start using the MiniMed™ 780G system in Auto Mode with G4S sensor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Phase Primary Endpoint: Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L])	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.	26 weeks
Continuation Phase Primary Endpoint: mean in HbA1c	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Phase Secondary Endpoint 1- Between-treatment difference in mean HbA1c	Between-treatment difference in mean HbA1c at the end of each 12-week period, non-inferiority test.	26 weeks
Study Phase Secondary Endpoint 2-Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L])	Between-treatment difference in % Time spent in target range (70 to 180 mg/dL [3.9-10.0 mmol/L]), simple superiority test.	26 weeks
Study Phase Secondary Endpoint 3-Between-treatment difference in mean HbA1c	Between-treatment difference in mean HbA1c at the end of each 12-week period, simple superiority test.	26 weeks
Continuation Phase Secondary Endpoint 1- Mean HbA1c	The secondary endpoints will be the between-treatment difference in Mean HbA1c at the end of the 12-week continuation phase period 2, simple superiority test.	12 weeks
Continuation Phase Secondary Endpoint 2- Time spent in target range (70 to 180 mg/dL [3.9-10.0 mmol/L])	The secondary endpoints will be the 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 with a margin of 7.5%.	12 weeks
Continuation Phase Secondary Endpoint 3- Time spent in target range (70 to 180 mg/dL [3.9-10.0 mmol/L])	The secondary endpoints will be the 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, simple superiority test.	12 weeks

Collaborators and Investigators

• Sponsor: Medtronic Diabetes
• Investigators: Study Chair: Ohad Cohen, MD, Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CIP342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes