Golden Sherita Hill, Sapir Tamar
Division of Endocrinology and Metabolism, Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University School of Medicine and Bloomberg School of Public Health, Johns Hopkins Evidence-Based Practice Center, Baltimore, MD, USA.
J Manag Care Pharm. 2012 Aug;18(6 Suppl):S1-17. doi: 10.18553/jmcp.2012.18.s6-A.1.
Diabetes mellitus is defined as a group of metabolic diseases characterized by hyperglycemia, which when untreated can lead to long-term complications, including micro- and macrovascular complications. Tight glycemic control with intensive insulin therapy has been suggested to reduce the risk of such complications in several diabetes populations; however, such an approach can also be associated with risks and challenges. There are currently several modalities available to deliver insulin and monitor glucose levels to achieve glycemic goals in diabetic patients. In July 2012, the Agency for Healthcare Research and Quality (AHRQ) published a systematic review on the comparative effectiveness of insulin delivery systems and glucose-monitoring modalities in diabetic patients receiving intensive insulin therapy. Studies from 44 publications included in the review compared the effects of continuous subcutaneous insulin infusion (CSII) with multiple daily injections (MDI) and/or real time-continuous glucose monitoring (rt-CGM) with self-monitoring of blood glucose (SMBG) among children, adolescents, or adults with either type 1 (T1DM) or type 2 diabetes (T2DM), or pregnant women with pre-existing diabetes (either T1DM or T2DM). This comparative effectiveness review evaluated which modality results in improved glycemic control, less hypoglycemia, better quality of life, and/or improved clinical outcomes. The numerous technologies and the challenges that clinicians face when determining which patient population may benefit from different insulin delivery systems and glucose-monitoring approaches motivated AHRQ to synthesize the available information to assist health professionals in making evidence-based practice decisions for their patients. The review also delineates advances in insulin delivery and glucose-monitoring systems, practical methods to achieve tight glycemic control and strategies to minimize associated risks, as well as highlights gaps in research and areas that need to be addressed in the future.
To (a) educate health care professionals on the findings from AHRQ's 2012 comparative effectiveness review on insulin delivery and glucose-monitoring modalities in patients with diabetes; (b) apply review findings to make treatment decisions in clinical practice; and (c) identify shortcomings in the current research and future directions relating to the comparative effectiveness of insulin delivery and glucose-monitoring modalities for patients with diabetes.
The AHRQ systematic review of randomized clinical trials reveals that both insulin delivery modalities (CSII and MDI) demonstrate similar effectiveness on glycemic control and severe hypoglycemia in children and adolescents with T1DM and in adults with T2DM. In adults with T1DM, hemoglobin A1c decreased more with CSII than with MDI with low strength of evidence, but one study heavily influenced these results. In children and adults with T1DM, the use of CSII was associated with improved quality of life compared with MDI, with low strength of evidence, while there was insufficient strength of evidence to make conclusions regarding the quality of life for adults with T2DM. The study investigators suggest that the modality to deliver intensive insulin therapy can be individualized to patient preference in order to maximize quality of life. On all measured outcomes, there was insufficient or low strength of evidence regarding pregnant women with pre-existing diabetes.The AHRQ investigators found studies comparing the effectiveness of glucose-monitoring modalities in individuals with T1DM only. The systematic review demonstrates that rt-CGM is associated with greater lowering of A1c compared with SMBG (high strength of evidence) without affecting the risk of severe hypoglycemia (low strength of evidence) or quality of life (low strength of evidence) in nonpregnant individuals with T1DM, particularly when compliance with device use is high. Additional findings suggest that the use of sensor-augmented insulin pumps (rt-CGM + CSII) is superior to the use of MDI/SMBG use in lowering A1c in nonpregnant individuals with T1DM (moderate strength of evidence). Comparison of other outcome measures did not yield firm conclusions due to low or insufficient evidence.
糖尿病被定义为一组以高血糖为特征的代谢性疾病，若不治疗可导致长期并发症，包括微血管和大血管并发症。在多个糖尿病群体中，建议采用强化胰岛素治疗进行严格的血糖控制，以降低此类并发症的风险；然而，这种方法也可能伴随着风险和挑战。目前有多种方式可用于注射胰岛素和监测血糖水平，以实现糖尿病患者的血糖目标。2012年7月，医疗保健研究与质量局（AHRQ）发表了一项关于胰岛素给药系统和血糖监测方式在接受强化胰岛素治疗的糖尿病患者中的比较效果的系统评价。该评价纳入的44篇出版物中的研究比较了持续皮下胰岛素输注（CSII）与多次皮下注射（MDI）和/或实时连续血糖监测（rt-CGM）与自我血糖监测（SMBG）在1型糖尿病（T1DM）或2型糖尿病（T2DM）儿童、青少年或成人，或患有糖尿病（T1DM或T2DM）的孕妇中的效果。这项比较效果评价评估了哪种方式能改善血糖控制、减少低血糖、提高生活质量和/或改善临床结局。临床医生在确定哪些患者群体可能从不同的胰岛素给药系统和血糖监测方法中获益时面临众多技术和挑战，这促使AHRQ综合现有信息，以协助卫生专业人员为其患者做出基于证据的实践决策。该评价还阐述了胰岛素给药和血糖监测系统的进展、实现严格血糖控制的实用方法以及将相关风险降至最低的策略，并突出了研究中的差距和未来需要解决的领域。
（a）让医疗保健专业人员了解AHRQ 2012年关于糖尿病患者胰岛素给药和血糖监测方式的比较效果评价结果；（b）应用评价结果在临床实践中做出治疗决策；（c）确定当前研究中关于糖尿病患者胰岛素给药和血糖监测方式比较效果的不足之处及未来方向。
AHRQ对随机临床试验的系统评价表明，在T1DM儿童和青少年以及T2DM成人中，两种胰岛素给药方式（CSII和MDI）在血糖控制和严重低血糖方面显示出相似的效果。在T1DM成人中，CSII组血红蛋白A1c的下降幅度大于MDI组，但证据强度较低，且有一项研究对这些结果有很大影响。在T1DM儿童和成人中，与MDI相比，使用CSII与生活质量改善相关，但证据强度较低，而对于T2DM成人的生活质量，证据强度不足以得出结论。研究调查人员建议，强化胰岛素治疗方式可根据患者偏好个体化，以最大限度提高生活质量。对于患有糖尿病的孕妇，在所有测量结局方面，证据不足或强度较低。AHRQ研究人员发现的研究仅比较了T1DM个体中血糖监测方式的效果。系统评价表明，与SMBG相比，rt-CGM与A1c的更大幅度降低相关（证据强度高），且不影响非妊娠T1DM个体的严重低血糖风险（证据强度低）或生活质量（证据强度低），特别是在设备使用依从性高的情况下。其他研究结果表明，在非妊娠T1DM个体中，使用传感器增强胰岛素泵（rt-CGM + CSII）在降低A1c方面优于使用MDI/SMBG（证据强度中等）。由于证据不足或强度较低，其他结局指标的比较未得出明确结论。
