NCT06363916招募中不适用
Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System in Children, Adolescents and Adults With Type 1 Diabetes
Medtrum France17 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年4月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 17
- 主要终点
- Superiority of the algorithm on Time In Range (TIR) between the 2 randomised groups
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults with type 1 diabetes (7-75 years old) in a home setting and to test the function of meal announcement in an extend study.
The main question it aims to answer is :
• Is the Hybrid Closed Loop system superior at increasing the time spent in the target glucose range of 70-180 mg/dL when compared to the Open (manual) Loop system ?
Participants will be :
- Trained into the use of the Insulin pump MEDTRUM A8 TouchCare® Insulin Management system
- Randomized to the Open Loop or Closed Loop group
- Respond to self administered questionnaires : the Hypoglycaemia Fear Survey, the Diabetes Quality of Life Questionnaire, and the Diabetes treatment Satisfaction Questionnaire status
Researchers will compare the time spent in the target glucose range of 70-180 mg/mL during the last 12 weeks of the study between the patients randomised to the Open Loop group and those randomised to the Closed Loop group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients living with Type 1 diabetes:
- •adults aged 18 to 75 years old (included)
- •children/adolescents aged 7 or older
- •Total daily dose of insulin ≥ 10 units per day & weighing >22 Kg
- •Patient and their parent(s)/guardian(s) trained and able to count carb
- •Current or previous insulin pump user or patient treated with multiple insulin injections
- •Patient glycaemic target is not achieved or suboptimal according to international consensus: HbA1c level equal and greater than 7% and less than 12% at the time of enrolment, or TIR < 70%, or TBR >4%
- •Any type of rapid insulin with a total daily insulin in the range of 10-60 IU (unauthorized use of insulin supplements by pen injector): Humalog™, Lyumjev (insulin lispro injection), Novorapid (insulin aspart) or FIASP® (" faster insulin aspart ")
- •Subject and their parent(s)/guardian(s) able to receive and understand study information, give written informed consent, and easily participate to the trial
- •Subject and their parent(s)/guardian(s) affiliated to the French social security system
- •Subject and their parent(s)/guardian(s) have the cognitive ability and can successfully operate all study devices and can adhere to the protocol
排除标准
- •Patient unable to tolerate tape adhesive, catheter or had any unresolved adverse skin condition and intolerance to steel
- •Patient not willing to perform finger stick blood glucose measurements required by the system and/or routine diabetes management
- •Patient with behaviour/lifestyle not compatible with optimal management of insulin therapy or deemed to be at significant risk of severe events (e.g. severe hypoglycaemia, diabetic ketoacidosis)
- •Unstable diabetic retinopathy
- •Pregnant women or planning to become pregnant during the study or breast-feeding
- •Patient abusing alcohol
- •Patient using DPP-4 inhibitor, GLP-1 agonists, metformin, or SGLT2 inhibitors during the last 3 months prior screening
- •Patient already participating in another interventional study
- •Patient currently using a hybrid closed loop system or patient who has stopped usage of Hybrid Closed loop system for less than 3 months
- •Patient under the protection of justice or under guardianship or curatorship, or hospitalised under duress or admitted to a health or social care establishment for purposes other than those of this investigation.
结局指标
主要结局
Superiority of the algorithm on Time In Range (TIR) between the 2 randomised groups
时间窗: V5 (6 months)
Comparison between the 2 groups of the proportion of time spent in the target glucose range of 70-180 mg/dL based on sensor measured glucose concentrations during last 12 weeks of the study
次要结局
- Superiority in Glycated Haemoglobin (HbA1c) improvement(V2 (Randomisation), V5 (6 months))
- Evolution of coefficient of glycemic variation(V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months))
- Percentage of patients with TIR > 70%(V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months))
- Evolution of TIR(V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months))
- Glucose sensor measurement change(V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months))
- Evolution of dosage of insulin(V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months))
- Time of device usage and time in automatic mode of insulin delivery (hybrid closed loop)(V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months))
- Safety Events(V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months))
- Evolution of Time spent Above Range (TAR)(V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months))
- Evolution of Time spent Below Range (TBR)(V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months))
- Evolution of glucose management indicator (GMI)(V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months))
- Evolution of Self-administered Questionnaires scores(V1 (Inclusion), V5 (6 months))
- Evolution of Diabetes Treatment Satisfaction score(V1 (Inclusion), V5 (6 months))
- Body Mass Index change(V1 (Inclusion), V2 (Randomisation), V5 (6 months))
- Percentage of patients with TIR > 70% and TBR < 4%, and with TIR > 70% and TBR < 1%(V1 (Inclusion), V2 (Randomisation), V3 (1 month), V4 (3 months), V5 (6 months))
研究者
研究点 (17)
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