应用胰岛素大剂量向导是否可以改善用每日多次注射不能达标患者的血糖控制？

Does Use Of An Insulin Bolus Advisor Improve Glycemic Control In People Not Achieving Optimal Control Using Multiple Daily Injections?

 应用胰岛素大剂量向导是否可以改善用每日多次注射不能达标患者的血糖控制？海南医学院附属医院内分泌科王新军

D.A. Cavan¹, R. Ziegler², I. Cranston³, K. Barnard⁴, J. Ryder¹, C. Vogel⁵, C.G. Parkin⁶, B. Petersen⁷, R.S. Wagner⁸

¹Royal Bournemouth Hospital, Bournemouth, UK, ²Diabetes Clinic for Children and Adolescents, Muenster, Germany, ³Queen Alexandra Hospital, Portsmouth, ⁴University of Southampton, Southampton, UK, ⁵Internistisches Fachaerztezentrum, Langen, Germany, ⁶CGParkin Communications, Boulder City, NV, USA, ⁷Roche Diagnostics GmbH, Mannheim, Germany, ⁸Roche Diagnostics, Indianapolis, IN, USA

 

Background: Manual bolus calculation requires the ability to use relatively complex math calculations. An insulin bolus advisor (BA) can help reduce this burden and recommend the appropriate insulin dose according to the amount of carbohydrates ingested and current blood glucose level while avoiding use of difficult calculations.

背景：人工大剂量计算需要使用相对复杂的数学计算能力。胰岛素大剂量向导（BA）可以帮助减轻这一负担，并可根据碳水化合物的摄入量和当前的血糖水平建议合适的胰岛素剂量，同时可以避免使用困难的计算方法。

Aim: Determine if use of a BA improves glycemic control in patients treated with multiple daily insulin injections (MDI) with elevated HbA1c levels, defined as HbA1c >7.5%.

目的：确定使用BA是否可以使每日多次注射胰岛素（MDI）而糖化血红蛋白仍高的患者（糖化血红蛋白>7.5％）改善血糖控制。

Methods: Prospective, randomized, multi-centre study. Study duration will be approximately 26 weeks from November 2011. A sample size of 114 (57 per study group) will have 90% power to detect a mean difference of 0.5%, with SD of 0.9% presuming a one-sided 5% significance level. Overall sample size: 285, assuming a drop-out rate of 20%.

方法：前瞻性、随机、多中心研究。该研究从2011年11月开始，为期大约26周。样本大小114例（每组57例）对于检测0.5％的平均差异，平均差0.9%，假设单尾5%显著性水平具有90％的效力。整体样本大小：285，假设20％的脱落率。

Results: The primary objective is to determine if using the BA improves glycemic control as measured by a change in HbA1c in MDI patients with elevated HbA1c levels. Secondary objectives:
? Change in time spent within blood glucose (bG) target range
? Frequency and severity of hypoglycaemia
? Change in glycemic variability parameters
? Change in magnitude of postprandial glucose excursions
? Frequency of bolus advisor use
? Frequency of participant adjustments to proposed bolus amounts
? SMBG test frequency
? Change in participants" therapy adherence and use of rule sets

结果：主要目的是观察使用BA是否可改善糖化血红蛋白升高的MDI患者的血糖控制（以糖化血红蛋白的变化为依据）。次要目标：
•血糖（BG）达标花费时间的变化
•低血糖的频率和严重性
•血糖变异性参数的变化
•餐后血糖波动幅度的变化
•大剂量向导使用的频率
•受试者调整建议追加量的频率
•SMBG的检测频率
•受试者的治疗依从性和应用原则设定的变化

Discussion: The bolus advisor may potentially benefit people using MDI to manage their diabetes more effectively and minimize the risk of long-term diabetes-related complications.

讨论：大剂量向导可能会使用MDI的患者获得潜在的益处，使糖尿病的治疗更有效，减少长期糖尿病相关并发症的风险。