Transition of T1DM Patients Aged Over 65 Years Into AHCL (780G) Insulin Pump: the Impact on Glucose Patterns, Quality of Life Physical & Cognitive Measures, as Well as Vascular Status
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
Older people with diabetes have a higher risk for cognitive impairment and for physical disability whether this may be effected by an improvement in glucose indices is unknown. Thus, the aim of this study is to assess the efficacy of AHCL in people with type 1 diabetes in improving glucose indices, quality of life and physical capacity indices
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 advanced hybrid closed loop (HCL) insulin pumps. The results of the AHCL insulin pump based studies published so far are very encouraging, including that Medtronic-sponsored study performed at our center "Transition of CSII/CGM naïve patients directly into AHCL (780G) insulin pump: the impact on glucose patterns and quality of life measures" (1-6). Unfortunately there is little data concerning the usage of AHCL systems in older patients. The management of these individuals is particularly challenging as older adults with type 1 diabetes are especially vulnerable to hypoglycaemia. The recent ADA/EASD consensus underlines that the use of advanced technologies in older individuals is useful and should not be discontinued or a priori excluded because of the older age (7). Since the AHCL systems are very effective in hypoglycemia prevention they could be considered the treatment of choice in older patients with T1DM. The open question is how effectively would older individuals adopt this advanced technology, how would they accept it, and if the simplicity in terms of everyday usage of AHCL versus less advanced technologies would be appreciated by older individuals with T1DM. Older people with diabetes have a higher risk for cognitive impairment and for physical disability whether this may be effected by an improvement in glucose indices is unknown. Thus, the aim of this study is to assess the efficacy of AHCL in people with type 1 diabetes in improving glucose indices, quality of life and physical capacity indices
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 65 years
- •Willing to participate in a study for the specified duration
- •Willing to perform ≥ 4 finger stick blood glucose measurements daily
- •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/CSII (with exclusion of 780G)
- •Willing to perform at least 4 BGM/day, when on MDI/CSII
- •Lack of advanced complications of diabetes, eGFR>30
排除标准
- •Severe concurrent illness
- •Laboratory abnormalities, or medications that might affect study participation,
- •Severe renal impairment (eGFR<30)
研究组 & 干预措施
Actual therapy
The patient continues Multiple Daily Injection/Insulin Pump Therapy with or without CGM use as per routine procedures
Advanced Hybrid Cloosed Loop System
The patients will be switched to MiniMed 780G advanced hybrid cloosed loop system/ AHCL system
干预措施: MiniMed 780G system (Device)
结局指标
主要结局
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).
时间窗: Month 12
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 difference in the percentage of time spent in hyperglycemic range in hypoglycemic range with SG < 70 mg/dL (3.9 mmol/L)(Month 12)
- QoL group difference using: The World Health Organisation- Five Well-Being Index (WHO-5)(Month 12)
- Differences in baseline vs end of the study in vascular status as measured with LDF: Laser Doppler Flowmetry(Month 12)
- Between groups difference in the percentage of participants achieving TIR >70%(Month 12)
- Between group difference in the percentage of time spent in hypoglycemic range with SG < 54 mg/dL (3.0 mmol/L)(Month 12)
- Difference in physical capacity indices listed in screening visit: Fried Scale(Month 12)
- Difference in physical capacity indices listed in screening visit: Berg Balance Scale(Month 12)
- Difference in physical capacity indices listed in screening visit: 6 Minute Walk Test(Month 12)
- Between group difference in the percentage of time spent in hyperglycemic range with SG > 250 mg/dL (13.9 mmol/L)(Month 12)
- Between group difference in the percentage of time spent in hyperglycemic range with SG > 180 mg/dL (10.0 mmol/L)(Month 12)
- Differences in baseline vs end of the study in vascular status as measured with FMD: Flow-Mediated Dilatation(Month 12)
- Differences in baseline vs end of the study in vascular status as measured with IMT-Intima-media thickness(Month 12)
- Difference in physical capacity indices listed in screening visit: Four Square Step(Month 12)
研究者
Tomasz Klupa
Prof. Tomasz Klupa
Jagiellonian University