Evaluation of the MiniMed 780 System in Paediatric Subjects

NCT ID: NCT05574062

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-24
• Study Completion Date: 2024-11-15

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.

Conditions

Diabetes type1; Children, Only

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All subjects

All subjects used the MiniMed 780G (with G4S sensor) system in Manual Mode for 2 weeks during the run-in phase and used the MiniMed™ 780G system in Auto Mode for 18 weeks during the continuation phase period 1

Group Type: OTHER

MiniMed 780G Auto Mode with G4S sensor

Intervention Type: DEVICE

MiniMed™ 780G system in Auto Mode with G4S sensor.

MiniMed 780G Manual Mode with G4S sensor

Intervention Type: DEVICE

MiniMed™ 780G system in Manual Mode.

Study phase - Sequence A

Subjects used the MiniMed 780G (with G4S sensor) system in Auto Mode for 12 weeks (Treatment), followed by 2 weeks of washout period where the system was used in Manual Mode with SBL activated (Control).

After the washout period the subjects used the MiniMed 780G (with G4S sensor) system in Manual Mode with SBL activated (Control).

Group Type: EXPERIMENTAL

MiniMed 780G Auto Mode with G4S sensor

Intervention Type: DEVICE

MiniMed™ 780G system in Auto Mode with G4S sensor.

MiniMed 780G Manual Mode with G4S sensor

Intervention Type: DEVICE

MiniMed™ 780G system in Manual Mode.

Study phase - Sequence B

Subjects used the MiniMed 780G (with G4S sensor) system in Manual Mode with SBL activated for 12 weeks (Control), followed by 2 weeks of washout period where the system was used in Manual Mode with SBL activated (Control).

After the washout period the subjects used the MiniMed 780G (with G4S sensor) system in Auto Mode (Treatment).

Group Type: EXPERIMENTAL

MiniMed 780G Auto Mode with G4S sensor

Intervention Type: DEVICE

MiniMed™ 780G system in Auto Mode with G4S sensor.

MiniMed 780G Manual Mode with G4S sensor

Intervention Type: DEVICE

MiniMed™ 780G system in Manual Mode.

Continuation Phase - Arm A2

Subjects will start using the MiniMed™ 780G BLE 2.0 system in Auto Mode with the DS5 sensor

Group Type: EXPERIMENTAL

MiniMed 780G Auto Mode with DS5 sensor

Intervention Type: DEVICE

MiniMed 780G Auto Mode with DS5 sensor

Continuation Phase - Arm B2

Subjects will continue to use MiniMed™ 780G system in Auto Mode with G4S sensor for 12 weeks

Group Type: ACTIVE_COMPARATOR

MiniMed 780G Auto Mode with G4S sensor

Intervention Type: DEVICE

MiniMed™ 780G system in Auto Mode with G4S sensor.

Interventions

MiniMed 780G Auto Mode with G4S sensor

MiniMed™ 780G system in Auto Mode with G4S sensor.

Intervention Type: DEVICE

MiniMed 780G Manual Mode with G4S sensor

MiniMed™ 780G system in Manual Mode.

Intervention Type: DEVICE

MiniMed 780G Auto Mode with DS5 sensor

MiniMed 780G Auto Mode with DS5 sensor

Intervention Type: DEVICE

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ohad Cohen, MD

Role: STUDY_CHAIR

Medtronic

Locations

HUS

Espoo, , Finland

Tampere University Hospital

Tampere, , Finland

Turku University Hospital

Turku, , Finland

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

University Medical Center Ljubljana (UMCL)

Ljubljana, , Slovenia

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

Countries

Finland; Italy; Slovenia; United Kingdom

References

Battelino T, Kuusela S, Shetty A, Rabbone I, Cherubini V, Campbell F, Ahomaki R, Tuomaala AK, Peters C, Iafusco D, Sundaram P, Schiaffini R, Cellot J, Gulotta F, Di Piazza F, Cohen O; LENNY study group. Efficacy and safety of automated insulin delivery in children aged 2-6 years (LENNY): an open-label, multicentre, randomised, crossover trial. Lancet Diabetes Endocrinol. 2025 Aug;13(8):662-673. doi: 10.1016/S2213-8587(25)00091-9. Epub 2025 Jun 19.

Reference Type: DERIVED

PMID: 40544853 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CIP342

Identifier Type: -

Identifier Source: org_study_id