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

• ClinicalTrials.gov Identifier: NCT05574062
• Recruitment Status: Active, not recruiting
• First Posted: October 10, 2022
• Last Update Posted: February 1, 2024
• Sponsor: Medtronic Diabetes
• Information provided by (Responsible Party): Medtronic Diabetes

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Diabetes type1; Children, Only	Device: Study Phase: MiniMed 780G Auto Mode with G4S sensor; Device: Study Phase: MiniMed 780G Manual Mode with G4S sensor; Device: Continuation phase: MiniMed 780G BLE 2.0 with DS5 sensor; Device: Continuation Phase MiniMed 780G Auto Mode with G4S sensor	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment

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).

• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: March 24, 2023
• Estimated Primary Completion Date: May 1, 2024
• Estimated Study Completion Date: November 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Study Phase Secondary Endpoint 1- Between-treatment difference in mean HbA1c [ Time Frame: 26 weeks ]
   Between-treatment difference in mean HbA1c at the end of each 12-week period, non-inferiority test.
2. Study Phase Secondary Endpoint 2-Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) [ Time Frame: 26 weeks ]
   Between-treatment difference in % Time spent in target range (70 to 180 mg/dL [3.9-10.0 mmol/L]), simple superiority test.
3. Study Phase Secondary Endpoint 3-Between-treatment difference in mean HbA1c [ Time Frame: 26 weeks ]
   Between-treatment difference in mean HbA1c at the end of each 12-week period, simple superiority test.
4. Continuation Phase Secondary Endpoint 1- Mean HbA1c [ Time Frame: 12 weeks ]
   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.
5. Continuation Phase Secondary Endpoint 2- Time spent in target range (70 to 180 mg/dL [3.9-10.0 mmol/L]) [ Time Frame: 12 weeks ]
   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%.
6. Continuation Phase Secondary Endpoint 3- Time spent in target range (70 to 180 mg/dL [3.9-10.0 mmol/L]) [ Time Frame: 12 weeks ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

Finland

HUS

Espoo, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland

Italy

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

Ancona, Italy

Azienda Ospedaliera Universitaria Luigi Vanvitelli

Napoli, Italy

Ospedale Maggiore della Carità di Novara

Novara, Italy

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Slovenia

University Medical Center Ljubljana (UMCL)

Ljubljana, Slovenia

United Kingdom

Noah's Ark Children's Hospital for Wales

Cardiff, United Kingdom

LEEDS TEACHING HOSPITALS NHS TRUST - St James

Leeds, United Kingdom

Leicester Royal Infirmary

Leicester, United Kingdom

UCLH (University College London Hospitals)

London, United Kingdom

Sponsors and Collaborators

Medtronic Diabetes

Investigators

• Study Chair: Ohad Cohen, MD; Medtronic

More Information

• Responsible Party: Medtronic Diabetes
• ClinicalTrials.gov Identifier: NCT05574062
• Other Study ID Numbers: CIP342
• First Posted: October 10, 2022
• Last Update Posted: February 1, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases