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1型糖尿病血糖连续监测:一项卫生技术评估

Continuous Monitoring of Glucose for Type 1 Diabetes: A Health Technology Assessment.

出版信息

Ont Health Technol Assess Ser. 2018 Feb 21;18(2):1-160. eCollection 2018.

Abstract

BACKGROUND

Type 1 diabetes is a condition in which the pancreas produces little or no insulin. People with type 1 diabetes must manage their blood glucose levels by monitoring the amount of glucose in their blood and administering appropriate amounts of insulin via injection or an insulin pump. Continuous glucose monitoring may be beneficial compared to self-monitoring of blood glucose using a blood glucose meter. It provides insight into a person's blood glucose levels on a continuous basis, and can identify whether blood glucose levels are trending up or down.

METHODS

We conducted a health technology assessment, which included an evaluation of clinical benefit, value for money, and patient preferences related to continuous glucose monitoring. We compared continuous glucose monitoring with self-monitoring of blood glucose using a finger-prick and a blood glucose meter. We performed a systematic literature search for studies published since January 1, 2010. We created a Markov model projecting the lifetime horizon of adults with type 1 diabetes, and performed a budget impact analysis from the perspective of the health care payer. We also conducted interviews and focus group discussions with people who self-manage their type 1 diabetes or support the management of a child with type 1 diabetes.

RESULTS

Twenty studies were included in the clinical evidence review. Compared with self-monitoring of blood glucose, continuous glucose monitoring improved the percentage of time patients spent in the target glycemic range by 9.6% (95% confidence interval 8.0-11.2) to 10.0% (95% confidence interval 6.75-13.25) and decreased the number of severe hypoglycemic events.Continuous glucose monitoring was associated with higher costs and small increases in health benefits (quality-adjusted life-years). Incremental cost-effectiveness ratios (ICERs) ranged from $592,206 to $1,108,812 per quality-adjusted life-year gained in analyses comparing four continuous glucose monitoring interventions to usual care. However, the uncertainty around the ICERs was large. The net budget impact of publicly funding continuous glucose monitoring assuming a 20% annual increase in adoption of continuous glucose monitoring would range from $8.5 million in year 1 to $16.2 million in year 5.Patient engagement surrounding the topic of continuous glucose monitoring was robust. Patients perceived that these devices provided important social, emotional, and medical and safety benefits in managing type 1 diabetes, especially in children.

CONCLUSIONS

Continuous glucose monitoring was more effective than self-monitoring of blood glucose in managing type 1 diabetes for some outcomes, such as time spent in the target glucose range and time spent outside the target glucose range (moderate certainty in this evidence). We were less certain that continuous glucose monitoring would reduce the number of severe hypoglycemic events. Compared with self-monitoring of blood glucose, the costs of continuous glucose monitoring were higher, with only small increases in health benefits. Publicly funding continuous glucose monitoring for the type 1 diabetes population in Ontario would result in additional costs to the health system over the next 5 years. Adult patients and parents of children with type 1 diabetes reported very positive experiences with continuous glucose monitoring. The high ongoing cost of continuous glucose monitoring devices was seen as the greatest barrier to their widespread use.

摘要

背景

1型糖尿病是一种胰腺分泌很少或不分泌胰岛素的疾病。1型糖尿病患者必须通过监测血液中的葡萄糖含量并通过注射或胰岛素泵给予适量胰岛素来管理血糖水平。与使用血糖仪进行自我血糖监测相比,持续葡萄糖监测可能有益。它能持续洞察一个人的血糖水平,并能识别血糖水平是呈上升还是下降趋势。

方法

我们进行了一项卫生技术评估,其中包括对与持续葡萄糖监测相关的临床益处、性价比和患者偏好的评估。我们将持续葡萄糖监测与使用指尖采血和血糖仪进行自我血糖监测进行了比较。我们对2010年1月1日以来发表的研究进行了系统的文献检索。我们创建了一个马尔可夫模型,预测1型糖尿病成年患者的终生情况,并从医疗保健支付者的角度进行了预算影响分析。我们还对自我管理1型糖尿病或支持1型糖尿病儿童管理的人群进行了访谈和焦点小组讨论。

结果

临床证据综述纳入了20项研究。与自我血糖监测相比,持续葡萄糖监测使患者处于目标血糖范围内的时间百分比提高了9.6%(95%置信区间8.0 - 11.2)至10.0%(95%置信区间6.75 - 13.25),并减少了严重低血糖事件的数量。持续葡萄糖监测与更高的成本和健康效益(质量调整生命年)的小幅增加相关。在将四种持续葡萄糖监测干预措施与常规护理进行比较的分析中,每获得一个质量调整生命年的增量成本效益比(ICER)范围为592,206美元至1,108,812美元。然而,ICER周围的不确定性很大。假设持续葡萄糖监测的采用率每年增加20%,为其提供公共资金的净预算影响在第1年为850万美元,在第5年为

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