Feasibility of Automated Insulin Delivery With an Interoperable Algorithm Using an Alternative Insulin Pump
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- % time spent in target glucose range measured by continuous glucose monitoring (3.9-10mmol/L, 70-180mg/dL)
研究概览
简要总结
This clinical study assesses the feasibility of implementing the inControl automated insulin delivery algorithm with Dexcom continuous glucose monitoring and a compatible insulin pump in adults with type 1 diabetes. It additionally provides pilot efficacy outcomes for interoperable automated insulin delivery.
详细描述
Self-management of type 1 diabetes is challenging, efforts to optimise time spent in the target range can result in hypo- and hyperglycaemia. Structured education, glucose monitoring and advances in insulin delivery can increase time in range and reduce exposure to extremes of glucose and recent data confirm that automated insulin delivery can enable further increases in time spent in the target range of 3.9 to 10mmol/L (70 - 180mg/dL).
The inControl algorithm, developed by TypeZero technologies is embedded in the Tandem X2 insulin pump and operates with the Dexcom G6 continuous glucose sensor and transmitter in a CE-marked and commercially available system (known as Control-IQ). This system optimises time in range compared with sensor-augmented pump therapy, and the improvement was maintained when participants were further randomised to predictive low glucose suspend or automated insulin delivery. The United States Food and Drug Administration has defined interoperable standards for automated insulin delivery systems, including the iCGM designation for continuous glucose sensors, the interoperable automated glycaemic controller designation, and alternate controller enabled insulin pumps. However, while standards have been defined, to date, interoperability of automated insulin delivery components has not been demonstrated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Aged 18 years of age or older
- •Type 1 diabetes confirmed on the basis of clinical features
- •Type 1 diabetes for greater than 1 year
- •On an intensified insulin regimen with multiple dose injection or insulin pump for > 3 months
- •HbA1c >7.5% (58mmol/mol) (or %TIR 3.9-10mmol/L <52% for participants already using a continuous glucose sensor)
排除标准
- •Total daily insulin dose greater than 100 units
- •Weight greater than 140kg
- •Pregnant or planning pregnancy
- •Have active malignancy or under investigation for malignancy
- •Severe visual impairment
- •Reduced manual dexterity
- •Use of any automated insulin delivery system
- •Unable to participate due to other factors, as assessed by the Chief Investigator
结局指标
主要结局
% time spent in target glucose range measured by continuous glucose monitoring (3.9-10mmol/L, 70-180mg/dL)
时间窗: Extracted from the final 28 days of the intervention period
Consensus measure of time in range
次要结局
- Gold score(At end of 12 week intervention period)
- % time spent in hypoglycaemia (<3.0mmol/L, 54mg/dL)(Extracted from the final 28 days of the intervention period)
- Treatment satisfaction (DTSQ, AP acceptability)(At end of 12 week intervention period)
- Nocturnal Severe hypoglycaemia (defined as requiring third party assistance)(Over 12 week intervention period)
- Glucose variability assessed by %Coefficient of Variation (%CV)(Extracted from the final 28 days of the intervention period)
- HbA1c(At end of 12 week intervention period)
- Change in total daily insulin dose (units)(At end of 12 week intervention period)
- % time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)(Extracted from the final 28 days of the intervention period)
- Number hypoglycaemic excursions (sensor glucose <3.0mmol/l for >= 20min)(Over 12 week intervention period)
- Glucose variability assessed by Low Blood Glucose Index (LBGI)(Extracted from the final 28 days of the intervention period)
- Time spent in automated insulin delivery mode(Over 12 week intervention period)
- % time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL)(Extracted from the final 28 days of the intervention period)
- % time spent in hyperglycaemia (>10mmol/L, 180mg/dL)(Extracted from the final 28 days of the intervention period)
- Severe hypoglycaemia (defined as requiring third party assistance)(Over 12 week intervention period)
- Glucose variability assessed by Mean Absolute Glucose (MAG)(Extracted from the final 28 days of the intervention period)
- Diabetes distress (PAID)(At end of 12 week intervention period)
- Change in weight (kg)(At end of 12 week intervention period)
- Diabetes distress (DDS-17)(At end of 12 week intervention period)