跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT04414280
NCT04414280进行中（未招募）不适用

The Impact of Hybrid Closed-loop Insulin Delivery (Medtronic MiniMed 670G and 780G System, Tandem t:Slim X2 Control-IQ, and Omnipod 5) on Glycemic Control and Patient-reported Outcomes in People Living With Type 1 Diabetes: a Multicenter Real-world Observational Study and Safety Study in Young Children (2-6 Years Old) in Belgium

Universitaire Ziekenhuizen KU Leuven56 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2020年3月12日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
1,600
试验地点
56
主要终点
Time in range
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Since February 2019 the first hybrid closed-loop insulin pump, the Medtronic MiniMed 670G system, has been offered to people with type 1 diabetes in Belgium. Despite previous studies, the impact of these automated insulin delivery systems on glycemic management and patient-reported outcomes (PROMs) under real-world conditions is still unclear. Therefore, this prospective, multicenter real-world observational study will evaluate the real-world impact of the Medtronic MiniMed 670G, Medtronic MiniMed 780G, Tandem Control-IQ and Omnipod 5 systems, separately, on glycemic management and PROMs in people living with type 1 diabetes and to evaluate the safety of the Medtronic MiniMed 780G in young children with type 1 diabetes (2-6 years old). Participants will be followed in routine clinical practice for a period of 24 months after initiation of the system. The primary endpoint is the evolution of time spent in range (defined as a sensor glucose value between 70 and 180 mg/dL) from before start to 12 months after start of hybrid closed-loop therapy.

Since not much is known about the impact of hybrid closed-loop on partners of adults living with type 1 diabetes, an optional substudy (INRANGE-PARTNER) will be performed investigating the quality of life in partners of adults of type 1 diabetes using hybrid closed-loop therapy. More specifically, the substudy will compare the quality of life of partners of type 1 diabetes patients both before and after implementation of hybrid closed-loop therapy.

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
2 Years 至 —（Child, Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •People with type 1 diabetes, aged 7 years and older who start with the Medtronic MiniMed 670G or 780G system, aged 6 years and older who start with the Tandem t:slim X2 Control-IQ or those aged 2 years and older who start with the Omnipod 5 in the participating centers and who signed informed consent or gave informed assent (pediatrics) are eligible to participate. For the safety study, children with type 1 diabetes aged 2-6 years old who start(ed) with the Medtronic MiniMed 780G system in Manual Mode, whose parents agree to enable Auto Mode (after at least 4 weeks of Manual Mode) and whose parents signed informed consent can be included. Auto Mode enablement is only possible if time since type 1 diabetes diagnosis is at least 6 months.
  • •The decision about which person with type 1 diabetes to start, is left to the clinical judgement of the treating health care professional.

排除标准

  • •patients without type 1 diabetes
  • •patients under 6 years of age
  • •patients not starting with hybrid closed-loop therapy in one of the 17 participating centers
  • •patients who did not sign informed consent

结局指标

主要结局

Time in range

时间窗: 12 months

The evolution of percentage of time spent in range (sensor glucose 70-180 mg/dL) from before start to 12 months after start

次要结局

  • Glycemic variability(from before start to 4, 8, 12 and 24 months after start)
  • Number of low glucose events(from before start to 4, 8, 12 and 24 months after start)
  • Time above range(from before start to 4, 8, 12 and 24 months after start)
  • Time in level 1 hypoglycemia(from before start to 4, 8, 12 and 24 months after start)
  • Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, worry (scale: 0 (not worried) - 60 (very worried))(from before start to 4, 8, 12 and 24 months after start of the Tandem Control-IQ for children)
  • Time in range(from before start to 4, 8, 12 and 24 months after start)
  • Time below range(from before start to 4, 8, 12 and 24 months after start)
  • Impact of diabetes and device satisfaction by the Diabetes Impact and Device Satisfaction Scale (scale: device satisfaction = 7 (not satisfied) - 70 (very satisfied); diabetes impact = 4 (low impact) - 40 (high impact))(from before start to 4, 8, 12 and 24 months after start of the Tandem Control-IQ for adults)
  • The Diabetes Quality of Life for Youth (DQOLY) questionnaire(from before start to 4, 8, 12 and 24 months after start for children)
  • Time in level 2 hypoglycemia(from before start to 4, 8, 12 and 24 months after start)
  • Mean glucose concentration(from before start to 4, 8, 12 and 24 months after start)
  • Correlation between sex (male/female) and change in HbA1c(from before start to 4, 8, 12 and 24 months after start)
  • Correlation between educational attainment (measured by a questionnaire with multiple options) and change in HbA1c(from before start to 4, 8, 12 and 24 months after start)
  • Correlation between cohabitation (yes/no) and change in HbA1c(from before start to 4, 8, 12 and 24 months after start)
  • Correlation between duration of diabetes (years) and change in HbA1c(from before start to 4, 8, 12 and 24 months after start)
  • Correlation between chronic diabetic complications (measured by a questionnaire with multiple options) and change in HbA1c(from before start to 4, 8, 12 and 24 months after start)
  • Correlation between total daily dose of insulin (units per day) and change in HbA1c(from before start to 4, 8, 12 and 24 months after start)
  • Hypoglycemia awareness measured by the Gold-scale (scale: 1 (aware) - 7 (unaware))(from before start to 4, 8, 12 and 24 months after start for adults and children)
  • Questionnaire for parents of children and adolescents with diabetes, a part of the HAPPI-D QOL Protocol (Hvidøre, Adolescent, Parent, Professional, Instrument, Diabetes)(from before start to 4, 8, 12 and 24 months after start for parents)
  • Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))(from before start to 4, 8, 12 and 24 months after start for adults)
  • Hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey (scale: unaware (≥4 times "R" or once "U") or aware (<4 times "R"))(from before start to 4, 8, 12 and 24 months after start for adults and children)
  • Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))(from before start to 4, 8, 12 and 24 months after start for adults)
  • Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))(from before start to 4, 8, 12 and 24 months after start for adults)
  • Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs. Scale: 0 (low satisfaction) - 36 (high satisfaction))(from before start to 4, 8, 12 and 24 months after start for adults)
  • Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))(from before start to 4, 8, 12 and 24 months after start for adults)
  • Treatment satisfaction measured by a self-developed questionnaire about expectations towards the use of the Medtronic MiniMed 670G system (multiple choice)(at 4, 8, 12 and 24 months after start of the Medtronic MiniMed 670G and 780G system for adults and children)
  • Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))(from before start to 4, 8, 12 and 24 months after start for children)
  • The Parent's fear of hypoglycemia scale - modified version of the Hypoglycemia Fear Survey for use with parents(from before start to 4, 8, 12 and 24 months after start for parents)
  • Time in level 1 hyperglycemia(from before start to 4, 8, 12 and 24 months after start)
  • HbA1c(from before start to 4, 8, 12 and 24 months after start)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

prof dr Pieter Gillard

Clinical Professor

Universitaire Ziekenhuizen KU Leuven

研究点 (56)

Loading locations...

相似试验

撤回
不适用
Hybrid Closed-Loop Insulin Delivery System in Type 1 Diabetes Candidates for a Living Donor Kidney TransplantDiabetes, Type 1
NCT03494010Yale University
已完成
不适用
Evaluation of Minimed 670G in T1D Patients on Multiple Daily InjectionDiabetes Mellitus, Type 1
NCT03755479Sidra Medicine30
已完成
不适用
Hybrid Closed Loop in High Risk Youth With Type 1 DiabetesType 1 Diabetes
NCT04807374Children's National Research Institute15
已完成
不适用
Acceptability of Hybrid Closed-loop Systems in Patients Living With Highly Unbalanced Type 1 DiabetesType 1 Diabetes
NCT05282264Centre Hospitalier Sud Francilien66
已完成
不适用
Hybrid Closed-loop Insulin Delivery System in Perioperative Diabetic Patients: an Open-label, Randomized Controlled TrialDiabetes Mellitus
NCT06295289Huazhong University of Science and Technology54
The Impact of Hybrid Closed-loop Insulin Delivery in... | 临床试验