Evaluation of the MiniMed 780 System in Young Paediatric Subjects (2-6 Years Old) With Type 1 Diabetes in a Home Setting (LENNY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 12
- 主要终点
- Study Phase Primary Endpoint: Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Non-inferiority Test
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 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.
- •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
研究组 & 干预措施
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
干预措施: MiniMed 780G Auto Mode with G4S sensor (Device)
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
干预措施: MiniMed 780G Manual Mode with G4S sensor (Device)
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).
干预措施: MiniMed 780G Auto Mode with G4S sensor (Device)
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).
干预措施: MiniMed 780G Manual Mode with G4S sensor (Device)
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).
干预措施: MiniMed 780G Auto Mode with G4S sensor (Device)
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).
干预措施: MiniMed 780G Manual Mode with G4S sensor (Device)
Continuation Phase - Arm A2
Subjects will start using the MiniMed™ 780G BLE 2.0 system in Auto Mode with the DS5 sensor
干预措施: MiniMed 780G Auto Mode with DS5 sensor (Device)
Continuation Phase - Arm B2
Subjects will continue to use MiniMed™ 780G system in Auto Mode with G4S sensor for 12 weeks
干预措施: MiniMed 780G Auto Mode with G4S sensor (Device)
结局指标
主要结局
Study Phase Primary Endpoint: Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Non-inferiority Test
时间窗: 12 weeks for each cross-over period
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.
Continuation Phase Primary Endpoint: Mean HbA1c (%) - Non-inferiority Test
时间窗: The outcome was measured at the end of the 12-week continuation phase period 2
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.
次要结局
- Study Phase Secondary Endpoint 1- Mean HbA1c (%) - Non-inferiority Test(The outcome was measured at the end of each 12 week cross-over period)
- Study Phase Secondary Endpoint 2 - Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Superiority Test(12 weeks for each cross-over period)
- Study Phase Secondary Endpoint 3 - Mean HbA1c (%) - Superiority Test.(The outcome was measured at the end of each 12 week cross-over period)
- Continuation Phase Secondary Endpoint 1- Mean HbA1c (%) - Superiority Test(The outcome was measured at the end of the 12-week continuation phase period 2)
- Continuation Phase Secondary Endpoint 2- Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Non-inferiority Test(12 weeks of continuation phase period 2)
- Continuation Phase Secondary Endpoint 3- Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Superiority Test(12 weeks of continuation phase period 2)