Advanced Hybrid Closed Loop System (780G) for People With Type 1 Diabetes Mellitus Patients Over the Age of 60: Efficacy in Improving Glucose Indices, Quality of Life, Cognitive Functions and Physical Capacity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Improvement of glucose measures in older individuals
研究概览
简要总结
The trial is a randomized controlled, parallel group design study. Patients will be followed up during approximatively 12 months.
Patients will be randomized to either the MDI/CSII group which will continue their treatment as per routine procedures and the advanced Hybrid Closed Loop system (AHCL) group which will be connected to the Minimed 780G system. .
At the end of the 12 month study period, we will evaluate whether the AHCL system improved glucose indices in older individuals with Type 1 diabetes mellitus (T1DM) and assess whether the ACHL treatment improved physical capacity, frailty & sarcopenia indices as well as quality of life and cognitive functions.
详细描述
All participants will go through a screening phase that includes an eligibility assessment, informed consent forms, Cognitive function assessment ( QoL questionnaire, WHO-5 questionnaire, MOCA, DSST, General Heath question), Sarcopenia/functional status/frailty assessment ( Timed up and Go , 6 min walk, 10 meter walk, Berg Balance Scale , Four Square Step Test , Grip Strength, 30 second chair stand, Fried Scale) and Lab tests.
After the screening, the participants will start a two week run in phase while continuing their routine procedures with an added unblinded G4 guardian standalone sensor.
sensor and data will be collected for 14 days and afterwards patients will be randomized to either the MDI/CSII group which will continue their treatment as per routine procedures and the AHCL group which will be connected to the Minimed 780G system. Both groups will have a similar number of visits in order to minimize bias. However, the AHCL group will have 2 additional visits to allow for patients to be trained on the AHCL system. After 6 months, both groups will be connected to the standalone sensor and glucose data will be collected after 2 weeks.
After 12 months of the study period, all participants will undergo primary assessments, blood tests questionnaires and will finish their part 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
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 60 years
- •Willing to participate in a study for the specified duration
- •Willing to perform ≥ 4 finger stick blood glucose measurements daily or connected to a "basket approved" CGM
- •Willing to wear the system continuously throughout the study
- •Treated with MDI/CSII (with exclusion of 780G or other hybrid closed systems)
- •Lack of advanced complications of diabetes
排除标准
- •Severe concurrent illness
- •Laboratory abnormalities, or medications that might affect study participation,
- •Severe renal impairment
- •Any illness that may interfere with study procedures
研究组 & 干预措施
AHCL group
Participants will be connected to the MiniMed 780G AHCL system for the 12 months study period. This group will have two additional visits to allow for patients to be trained on the AHCL system.
干预措施: MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system (Device)
MDI/CSII group
The patient will continue MDI/CSII treatment as per their routine procedures. At the beginning, middle and end of the stage they will be connected to a standalone sensor from which glucose data will be collected.
干预措施: MDI/CSII (Other)
结局指标
主要结局
Improvement of glucose measures in older individuals
时间窗: 12 months
The primary objective of this study is to evaluate whether the AHCL (MiniMed 780G) system improves glucose indices in older (above 60 years of age) individuals with Type 1 diabetes mellitus. Glucose differences between the groups will be monitored and evaluated by difference in the percentage of time spent within range with sensor glucose (SG) between 70-180 mg/dL (Primary outcome), time in hyperglycemic range SG \> 250 mg/dL , SG \> 180 mg/dL, time in hypoglycemic range with SG \< 70 mg/dL , SG \< 54 mg/dL as well as difference in the glycemic variability, mean glucose level and change in HbA1c levels.
次要结局
- 6 minute walk(12 months)
- Grip strength(12 months)
- Time up and go(12 months)
- Four Square Step Test (FSST)(12 months)
研究者
Dr. Tali Cukierman-Yaffe
Professor
Sheba Medical Center