McCall Anthony L, Cox Daniel J, Crean John, Gloster Maury, Kovatchev Boris P
Division of Endocrinology and Center for Diabetes and Hormone Excellence, Department of Internal Medicine, University of Virginia, Charlottesville, Virginia 22908, USA.
Diabetes Technol Ther. 2006 Dec;8(6):644-53. doi: 10.1089/dia.2006.8.644.
Marked blood glucose (BG) fluctuations may increase the risk of some complications associated with diabetes. Acute BG excursions are common in patients with diabetes, but are not usually quantified, nor can they be captured by glycosylated hemoglobin level. This study evaluated the sensitivity of novel analytical methods for assessing BG variability using CGMS (Medtronic Minimed, Northridge, CA) data from patients treated with pramlintide, a drug that acutely reduces postprandial hyperglycemia when added to insulin therapy.
Retrospective analyses were done on 24-h CGMS profiles obtained from 22 evaluable subjects with type 1 diabetes using insulin pumps and receiving preprandial three times daily injections of placebo (n = 6) or 30 microg of pramlintide (n = 16) for 4 weeks. CGMS data were recorded at baseline, after 4 weeks of treatment, and after 2 weeks off-treatment. Three parameters were calculated for each time period: variability (BG rate of change), an index for severe hypoglycemia [low BG index (LBGI)], and an index for marked hyperglycemia [high BG index (HBGI)].
The mean postprandial BG rate of change was significantly lower after 4 weeks of pramlintide treatment compared with placebo treatment (0.87 vs. 1.21 mg/dL/min, P < 0.01) without changes in average glycemia, illustrating the sensitivity of this parameter to medication effects. The HBGI and LBGI indicated a decreased risk of hyperglycemia without a significant increase in risk of hypoglycemia after 4 weeks of pramlintide.
These results suggest the potential utility of several novel methods for assessing variability and glycemic extremes to gauge the effects of pharmacological interventions not captured by glycosylated hemoglobin.
显著的血糖（BG）波动可能会增加一些糖尿病相关并发症的风险。急性血糖波动在糖尿病患者中很常见，但通常未被量化，糖化血红蛋白水平也无法反映这种波动。本研究使用连续血糖监测系统（CGMS，美敦力公司，北岭，加利福尼亚州）评估了新型分析方法对血糖变异性的敏感性，这些方法基于接受普兰林肽治疗患者的数据，普兰林肽是一种在胰岛素治疗基础上可急性降低餐后高血糖的药物。
对22例1型糖尿病可评估受试者进行回顾性分析，这些受试者使用胰岛素泵，并接受每日三次餐前注射安慰剂（n = 6）或30微克普兰林肽（n = 16）治疗4周。在基线、治疗4周后以及停药2周后记录CGMS数据。每个时间段计算三个参数：变异性（血糖变化率）、严重低血糖指数[低血糖指数（LBGI）]和显著高血糖指数[高血糖指数（HBGI）]。
与安慰剂治疗相比，普兰林肽治疗4周后餐后平均血糖变化率显著降低（0.87 vs. 未治疗前平均血糖变化率显著降低（0.87 vs. 1.21 mg/dL/分钟，P < 0.01），且平均血糖无变化，这说明该参数对药物作用敏感。普兰林肽治疗4周后，高血糖指数和低血糖指数显示高血糖风险降低，低血糖风险无显著增加。
这些结果表明，几种评估变异性和血糖极值的新方法可能有助于衡量糖化血红蛋白未反映的药物干预效果。
