Evaluation of the MiniMed 780 System in Paediatric Subjects

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the safety and performance of the MiniMed™ 780G system in paediatric subjects (2-6 years old) with type 1 diabetes in a home setting.

Detailed Description
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This MiniMed 780G system with Guardian 4 Sensor (G4S) 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). Study Phase: Sequence A: subjects will use the Advanced Hybrid Closed Loop (AHCL) therapy (i.e. 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 (i.e. 780G system in Manual Mode with SBL activated) (Control). Sequence B: subjects will continue to use predictive low-glucose suspend (i.e. 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 (i.e. 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. Continuation Phase: For the duration of the 26 week continuation phase, all enrolled subjects will be using the MiniMed 780G system in Auto Mode.

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

Conditions
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Diabetes type1, Children, Only

Intervention / Treatment
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* Device: MiniMed 780G Automode
* Device: MiniMed 780G Manual Mode + Suspend Before Low


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 IQ Control or CamAPS FX or other advanced hybrid closed loop therapy (e.g. DIY, MiniMed 780G) in the previous 3 months before enrollment. 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study consists of a run-in phase, a study phase and a continuation phase. Run-in Phase: Training on the MiniMed 780G system in Manual Mode with SBL activated and to collect 2 weeks of baseline data. Study Phase: Sequence A: subjects will use the AHCL therapy (i.e. 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 (i.e. 780G system in Manual Mode with SBL activated) (Control). Sequence B: subjects will continue to use predictive low-glucose suspend (i.e. 780G system in Manual Mode with SBL activated) (Control). After a washout phase of 2 weeks, subjects will use the AHCL therapy (i.e. MiniMed 780G system in Auto Mode) for 12 weeks (Treatment). Continuation Phase: For the duration of the 26 week continuation phase, all enrolled subjects will be using the MiniMed 780G system in Auto Mode.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AHCL therapy (i.e. MiniMed 780G system in Auto Mode)<br>Subjects will start using the MiniMed™ 780G system in Auto Mode for 12 weeks. | Device: MiniMed 780G Automode<br>* Subjects will start using the MiniMed™ 780G system in Auto Mode. The 780G system consists of: MiniMed™ 780G Insulin Pump with auto mode enabled Guardian™ 4 Sensor Guardian™ 4 Transmitter<br>|
| Active Comparator: Predictive low-glucose suspend (i.e. 780G system in Manual Mode with SBL activated)<br>Subjects will use the MiniMed™ 780G system in Manual Mode with SBL activated for 12 weeks. | Device: MiniMed 780G Manual Mode + Suspend Before Low<br>* Subjects will start using the MiniMed™ 780G system in Manual Mode. The 780G system consists of: MiniMed™ 780G Insulin Pump with manual mode + Suspend before Low enabled Guardian™ 4 Sensor Guardian™ 4 Transmitter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |