Evaluation of the MiniMed 780 System in Paediatric Subjects

Children, Only Clinical Trial

— LENNY  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05574062
• Other study ID #: CIP342
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 24, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: January 2024
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 101
• Est. completion date: November 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Children, Only
• Diabetes Mellitus, Type 1
• Diabetes type1

Intervention

Device:
• Study Phase: MiniMed 780G Auto Mode with G4S sensor
Subjects will start using the MiniMed™ 780G system in Auto Mode with G4S sensor.
• Study Phase: MiniMed 780G Manual Mode with G4S sensor
Subjects will start using the MiniMed™ 780G system in Manual Mode.
• Continuation phase: MiniMed 780G BLE 2.0 with DS5 sensor
Subjects will start using the MiniMed 780G BLE 2.0 with DS5 sensor
• Continuation Phase MiniMed 780G Auto Mode with G4S sensor
Subjects will start using the MiniMed™ 780G system in Auto Mode with G4S sensor.

Locations

Country	Name	City	State
Finland	HUS	Espoo
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku
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
Slovenia	University Medical Center Ljubljana (UMCL)	Ljubljana
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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Countries where clinical trial is conducted

Finland,  Italy,  Slovenia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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