Glucose Control With Medtronic 780G System in Adults With Diabetes and Advanced Renal Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Percent time in sensor glucose target range (3.9-10.0 mmol/L)
研究概览
简要总结
Diabetes is the leading cause of kidney failure in the UK. Many people with diabetes and advanced kidney failure inject themselves with insulin and do finger-prick blood glucose tests. Managing diabetes in people with advanced kidney disease is hard, with fluctuating glucose levels and an increased risk of unsafe low glucose levels.
There are currently continuous glucose monitors (CGM), which allow people to monitor glucose without painful fingerprick tests. CGM can be combined with insulin pumps to create automated insulin delivery systems (AID) that deliver insulin automatically to control glucose. AID systems are currently used in people with type 1 diabetes, but they are not used in people with type 2 diabetes. There is little information on how these systems might help people with diabetes and advanced kidney failure and on dialysis.
This study will investigate whether automated insulin delivery can improve glucose levels and quality of life in people with diabetes treated with more than one insulin injection with advanced kidney failure and/or undergoing regular dialysis treatment. This study will be a feasibility study conducted in a single centre (Imperial College, London) and be of a cross-over design. The study will aim to complete 12 people. Participants will wear a glucose sensor at the start. In random order, half will start AID followed by the usual treatment, while the other half will start the usual treatment followed by AID treatment. The duration of each treatment stage is eight weeks. The study will last about 22 weeks for each participant. Investigators will compare the glucose levels in the AID group with the usual care group to see if there is a difference. Questionnaires and interviews will help us understand participants' experiences. Investigators will carefully monitor the safety of participants.
详细描述
This will be a single-centre, prospective, open-label, two-stage, randomized crossover study comparing automated subcutaneous insulin delivery (AID), also known as Hybrid Closed Loop (HCL) therapy using the 780G system with usual insulin therapy plus continuous glucose monitoring (CGM) in people with type 1 and type 2 diabetes complicated by advanced renal disease and managed with insulin. The study will be conducted at Imperial College Healthcare NHS Trust.
Duration of each treatment arm is 8 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age 18-70 years inclusive
- •2. Type 1 diabetes of at least 1-year duration or insulin-requiring type 2 diabetes managed with multiple daily injections (MDI [ie separate rapid-acting and basal insulin injections]) or insulin pump therapy (CSII)
- •3. The HbA1c <10.5% (<91 mmol/mol)
- •4. The total daily dose of insulin <200Units
- •5. The participant is willing and able to implement the study requirements.
- •6. Participant has advanced renal disease (Group A: Stage 3b or greater renal failure (eGFR <45millilitres/minute/1.73m2); Group B: ESKD requiring peritoneal dialysis; Group C: ESKD requiring haemodialysis
- •7. Participants (and carer where applicable) should be able to speak and understand English sufficiently for safe study conduct
- •8. The participant has internet or smartphone access, enabling upload of the 780G system data to cloud-based software
排除标准
- •1. The participant is already using an AID system
- •2. The participant is treated with sulphonylureas (SGLT2 inhibitors, metformin, and GLP1 analogues may be used within regulatory guidelines) in pre-dialysis participants (Group A). In Groups B & C, noninsulin glucose-lowering therapies are not permitted, with the exception of GLP1 agonists used in preparation for transplantation
- •3. The participant has a recent history of diabetic ketoacidosis (<6 months)
- •4. The use of systemic steroid therapy within the past four weeks (stable doses of steroids for >8 weeks permitted)
- •5. The participant has significant cognitive impairment or major psychiatric history affecting safe study conduct
- •6. Known significant allergy to tape/ adhesives
- •7. Women who are pregnant or planning pregnancy
- •8. The participant has an active major life-threatening illness limiting the participants life expectancy to <6 months
- •9. The participant is on hydroxyurea treatment or taking regular / daily paracetamol treatment (sensor interference)
结局指标
主要结局
Percent time in sensor glucose target range (3.9-10.0 mmol/L)
时间窗: 3 weeks
Percent time in sensor glucose target range (3.9-10.0 mmol/L) with Automated Insulin Delivery (AID) versus Usual Care measured during the final 3 weeks of each study stage.
次要结局
- Percent time in sensor glucose target range (<3.3 mmol/L)(3 weeks)
- Percent time in sensor glucose target range (>16.7 mmol/L)(3 weeks)
- Number of hospitalised and non-hospitalised patients with severe hypoglycaemia(8 weeks)
- Percent time in sensor glucose target range (>13.9 mmol/L)(3 weeks)
- Percent time in sensor glucose target range (3.9-7.8 mmol/L)(3 weeks)
- Mean sensor glucose(3 weeks)
- Standard deviation and coefficient of variation of sensor glucose(3 weeks)
- Percent time in sensor glucose target range (<3.0 mmol/L)(3 weeks)
- Percent time in sensor glucose target range (>10 mmol/L)(3 weeks)
- Percent time in sensor glucose target range (<2.8 mmol/L)(3 weeks)
- The Diabetes Treatment Satisfaction Questionnaire status(8 weeks)
- Hypoglycaemia Fear Survey(8 weeks)
- EQ-5D-5L(8 weeks)
- Percent time in sensor glucose target range (<3.9 mmol/L)(3 weeks)
- Episodes of CGM time in <3.0mmol/L range lasting >15minutes(3 weeks)
- Number of hospital admissions with diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycaemia(8 weeks)