An Evaluation of the Tandem IQ Insulin Pump and DEXCOM G6 Continuous Glucose Monitoring Hybrid Closed Loop Insulin Delivery System (Control-IQ) on Patient Wellbeing and Diabetes Control in Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NHS Lothian
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time in range
研究概览
简要总结
Treatment of Type 1 diabetes requires daily insulin therapy given by either multiple daily injections or by continuous infusion via a pump. The insulin dose is calculated taking into consideration blood glucose levels, food intake and activity levels, aiming to avoid high and low readings.
The Tandem t:slim X2™ insulin pump has recently become available in NHS Scotland and can link with the Dexcom G6 continuous glucose monitoring (CGM) system.
The Tandem Control IQ hybrid closed loop system is made up of the Tandem insulin pump communicating wirelessly with the Dexcom G6 CGM. The algorithm within the pump then automatically controls the background (basal) insulin infusion rate. Manually delivered bolus insulin is still required for meals. This system is designed to finely tune insulin delivery and increase the amount of time that glucose is in the target range, reducing hypoglycaemia and hyperglycaemia.
Insulin pumps are funded by NHS Scotland, but the Dexcom G6 continuous glucose monitoring system is not, so this hybrid closed loop system is not currently routinely available in NHS Scotland.
The purpose of this study is to gain experience of this system and investigate how effective and acceptable the hybrid closed loop system is for people in Scotland. Participants will be provided with the Dexcom G6 CGM device to link to their current pump to create the hybrid closed loop system for the duration of the study.
30 people with Type 1 diabetes who have been using the Tandem pump for at least one month will be invited to participate.
The study will include a screening visit, a 30 day run-in period, 52 week treatment period and 12 week follow-up period. Diabetes control will be measured using HbA1c and downloaded information from the hybrid closed loop system. Participants will also complete questionnaires and a reflective diary.
详细描述
In those without diabetes insulin is automatically secreted according to requirement. The background insulin secretion rate will vary depending on need, and is affected by many factors e.g. activity or stress levels. When a person eats the rise of glucose is sensed and insulin automatically secreted to keep the glucose within a narrow range.
People with Type 1 diabetes cannot make insulin to control their blood glucose. Insulin is therefore required as treatment. This is given subcutaneously by injection or using an infusion pump. Both background insulin is required and boluses of insulin given when carbohydrate is eaten.
It is difficult to accurately calculate and deliver the correct amount of insulin. More recently standard treatment involved giving one of two injections of long acting insulin and more frequent injections of fast acting insulin when carbohydrate is ingested. The dose of insulin is determined by measuring the ambient glucose level, knowing the amount of carbohydrate in any meal and predicting activity during the subsequent four or five hours.
Insulin pumps can be used to provide a pre-tuned variable background insulin infusion with manual intervention to deliver boluses of insulin with food.
In Scotland many people have now replaced finger prick glucose testing with flash glucose monitoring. This uses a small subcutaneous needle that senses subcutaneous glucose levels and, when scanned this sensor will provide a measure of subcutaneous glucose and information on the last 8 hours of glucose values (Flash Glucose monitoring). This system does not currently link to an insulin pump.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Type 1 diabetes
- •Established on the Tandem pump for at least 1 month, using novorapid or humalog insulin
- •HbA1c 40-90 mmol/mol inclusive within the previous 30 days or taken at screening
- •Total daily dose of insulin 10-100 units
- •Willing to attend study visits and complete all study assessments
- •Able to give informed consent
排除标准
- •Pregnant or planning pregnancy
- •Any disorder which, in the investigators' opinion might jeopardise the patient's safety or compliance with the protocol
- •Life expectancy less than one year
- •Severe renal impairment (eGFR <30ml/min)
- •Weight <25kg
- •Patients prescribed hydroxycarbamide
结局指标
主要结局
Time in range
时间窗: Change from baseline to 4, 12, 26 and 52 weeks after initiation of the Control-IQ hybrid closed loop system
Percentage of time glucose is in range (download of Dexcom results)
Time Control IQ system not in use
时间窗: From baseline to 4, 12, 26 and 52 weeks after initiation of the system.
Time when the Control-IQ hybrid closed loop system is not in use
HbA1c
时间窗: Change from baseline to 20 days after initiation of the sensor, and at 4, 12, 26, 52 and 64 weeks after initiation of the Control-IQ hybrid closed loop system
Measurement of HbA1c
Severe hypoglycaemia
时间窗: Change from the 12 weeks before baseline measures to 20 days after initiation of the sensor, and at 4, 12, 26, 52 and 64 weeks after initiation of the Control-IQ hybrid closed loop system.
Self reported severe hypoglycaemia
Time in hypoglycaemia
时间窗: Change from baseline to 4, 12, 26 and 52 weeks after initiation of the Control-IQ hybrid closed loop system.
Percentage of time hypoglycaemic
次要结局
- Diabetes distress score(Change from baseline to 4, 12, 26, 52 and 64 weeks after initiation of the Control-IQ hybrid closed loop system.)
- Problem Areas In Diabetes questionnaire(Change from baseline to 4, 12, 26, 52 and 64 weeks after initiation of the Control-IQ hybrid closed loop system.)
- Patient experience diary(Change from baseline to 4, 12, 26, 52 and 64 weeks after initiation of the Control-IQ hybrid closed loop system.)
- Hospital Anxiety and Depression questionnaire(Change from baseline to 4, 12, 26, 52 and 64 weeks after initiation of the Control-IQ hybrid closed loop system.)