Transition of Patients With T1D From Multiple Daily Injection (MDI) and Self-Monitoring of Blood Glucose (SMBG) Directly to MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) System :Impact on Glucose Control and Quality of Life Measures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Between group TIR difference
研究概览
简要总结
The primary objective of this study is to evaluate whether the MiniMed 780G AHCL system improves glycemic control and Quality of Life (QoL) perception in adult individuals with T1D and naïve to CSII and CGM technologies.
The trial is a two-centers, randomized controlled, parallel group study. Patients will be followed up during approximatively 3 months.
详细描述
Recent advances in insulin pumps, continuous glucose monitoring (CGM) devices, and control algorithms have resulted in an acceleration of progress in the development of the automated systems of insulin delivery including hybrid closed loop (HCL) systems.
Initial studies on the MiniMed 670G system, the first HCL system approved, have reported increased glycemic control in both adults and pediatrics, having experience with insulin pump therapy with or without experience of CGM technology. More recently it was shown shown even further improvement in glycemic control with the 670G system, in children and adolescents naïve to both pump and CGM technologies. This may be, at least partially, due to lack of willingness of patients to "let the algorithm work" based on their previous experience with CSII and CGM.
The investigators aim to evaluate the impact of an Advanced Hybrid Closed Loop (AHCL) system in adults naïve to pump and CGM technology. For this purpose the investigators target the population of T1DM individuals who are older than 26 years. The study will be conducted in Poland, where only individuals under the age of 26 are entitled to CSII/CGM reimbursement.
If the study succeeds in terms of improved glycemic patterns, quality of life and patients' acceptance, it may provide evidence for consideration in CSII/CGM reimbursement for this population.
Devices usage in the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 26 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 26 - 60 years at time of screening a clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- •Willing to participate in a study for the specified duration
- •Willing to perform ≥ 4 finger stick blood glucose measurements daily
- •Willing to perform required sensor calibrations
- •Willing to wear the system continuously throughout the study
- •Glycosylated hemoglobin (A1C) value less than 10.0% at time of screening visit
- •Treated with MDI
- •Willing to perform at least 4 BGM/day, when on MDI
- •At least communicative level of English to be able to understand the pump interface.
排除标准
- •Previous treatment with CSII/CGM
- •Usage of ultra-rapid insulins, e.g. FIASP
- •concurrent illness
- •laboratory abnormalities, or medications that might affect study participation,
- •current pregnancy
- •renal impairment
- •hemoglobin A1c value above 10%.
研究组 & 干预措施
MDI group:
The patient continues MDI treatment as per routine procedures
AHCL group
The patient will use MiniMed 780G AHCL system
干预措施: insulin pump Medtronic 780G (Device)
结局指标
主要结局
Between group TIR difference
时间窗: Day 78-90
Between group difference in the percentage of time spent within range with sensor glucose (SG) between 70-180 mg/dL (TIR) (3.9-10.0 mmol/L).
次要结局
- Between group TIR difference >70%(Day 78-90)
- Between group difference in the mean glucose level(Day 78-90)
- Between group difference in the percentage of time spent:(Day 78-90)
- Between group difference in the HbA1c levels(Day 78-90)
- Between group difference in the glycemic variability measure by SD and CV(Day 78-90)
- Between group difference in the Diabetes Quality of Life (QoL) questionnaire score(Day 90)
研究者
Tomasz Klupa
Prof
Jagiellonian University