Implementation of a Health Plan Program for Switching From Analogue to Human Insulin and Glycemic Control Among Medicare Beneficiaries With Type 2 Diabetes
Implementation of a Health Plan Program for Switching From Analogue to Human Insulin and Glycemic Control Among Medicare Beneficiaries With Type 2 Diabetes
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DOI：
10.1001/jama.2018.21364
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发表时间：
2019-01-29
影响因子：
120.7
通讯作者：
Kesselheim, Aaron S.
中科院分区：
文献类型：
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作者：
Luo, Jing;Khan, Nazleen F.;Kesselheim, Aaron S.
较新的类似胰岛素产品的重要性价格已经上涨。目的评价一项基于健康计划的干预措施的实施与血糖控制之间的关系。设计、设置和参与者一项采用人群水平中断时间序列分析的回溯性队列研究，研究对象是参与美国4个州的联邦医疗保险优势计划和处方药计划的成员。参与者在2014年1月1日至2016年12月31日期间服用胰岛素(平均随访729天)。干预从2015年2月开始，到2015年6月扩展到整个健康计划系统。实施健康计划计划，将患者从模拟胰岛素切换到人类胰岛素。主要结果和衡量主要结果是在三个12个月期间估计的平均血红蛋白A(1c)(HBA(1c))水平的变化：2014年干预前(基线)、2015年干预和2016年干预后。次要结果包括使用ICD-9-CM和ICD-10-CM诊断代码的严重低血糖或高血糖发生率。结果3年来，14635名成员(平均[SD]年龄：72.5[9.8]岁；51%女性；93%2型糖尿病)开出221866张胰岛素处方。治疗前HbA(1c)平均为8.46%(95%CI，8.40%~8.52%)，干预前每月下降-0.02%(95%CI，-0.03%~-0.01%；P<0.01)。干预开始与HbA(1c)水平上升0.14%(95%CI，0.05%-0.23%；P=0.003)和斜率变化0.02%(95%CI，0.01%-0.03%；P<；.001)相关。干预结束后，平均HbA(1c)水平(0.08%[95%CI，-0.01%~0.17%])或斜率(<；0.001%[95%CI，-0.008%~0.010%])与干预期间相比差异无统计学意义(P=0.09和P=0.81)。对于严重的低血糖事件，开始干预与水平(2.66/1000人年[95%CI，-3.82至9.13]；P=0.41)或斜率变化(-0.66/1000人年[95%CI，-1.59至0.27]；P=0.16)之间没有显著关联。干预后水平(1.64/1000人年[95%CI，-4.83~8.11]；P=.61)和斜率(-0.23/1000人年[95%CI，-1.17~0.70]；P=.61)变化与干预期无显著差异。重度高血糖基线患病率为22.33/1000人年(95%CI，12.70~31.97)。对于严重高血糖事件的发生率，干预开始与水平(4.23/1000人年[95%CI，-8.62至17.08]；P=.51)或斜率(-0.51/1000人年[95%CI，-2.37至1.34]；P=.58)变化没有显著关联。结论与2型糖尿病医疗保险受益人之间的相关性，实施涉及将患者从类似物转换为人胰岛素的健康计划计划的实施与人口水平HBA(1c)的小幅增加有关。
IMPORTANCE Prices for newer analogue insulin products have increased. Lower-cost human insulin may be effective for many patients with type 2 diabetes.OBJECTIVE To evaluate the association between implementation of a health plan-based intervention of switching patients from analogue to human insulin and glycemic control.DESIGN, SETTING, AND PARTICIPANTS A retrospective cohort study using population-level interrupted times series analysis of members participating in a Medicare Advantage and prescription drug plan operating in 4 US states. Participants were prescribed insulin between January 1, 2014, and December 31, 2016 (median follow-up, 729 days). The intervention began in February 2015 and was expanded to the entire health plan system by June 2015.EXPOSURES Implementation of a health plan program to switch patients from analogue to human insulin.MAIN OUTCOMES AND MEASURES The primary outcome was the change in mean hemoglobin A(1c) (HbA(1c)) levels estimated over three 12-month periods: preintervention (baseline) in 2014, intervention in 2015, and postintervention in 2016. Secondary outcomes included rates of serious hypoglycemia or hyperglycemia using ICD-9-CM and ICD-10-CM diagnostic codes.RESULTS Over 3 years, 14 635 members (mean [SD] age: 72.5 [9.8] years; 51% women; 93% with type 2 diabetes) filled 221 866 insulin prescriptions. The mean HbA(1c) was 8.46%(95% CI, 8.40%-8.52%) at baseline and decreased at a rate of -0.02%(95% CI, -0.03% to -0.01%; P < .001) per month before the intervention. There was an association between the start of the intervention and an overall HbA(1c) level increase of 0.14%(95% CI, 0.05%-0.23%; P = .003) and slope change of 0.02% (95% CI, 0.01%-0.03%; P < .001). After the completion of the intervention, there were no significant differences in changes in the level (0.08% [95% CI, -0.01% to 0.17%]) or slope (< 0.001%[95% CI, -0.008% to 0.010%]) of mean HbA(1c) compared with the intervention period (P = .09 and P = 0.81, respectively). For serious hypoglycemic events, there was no significant association between the start of the intervention and a level (2.66/1000 person-years [95% CI, -3.82 to 9.13]; P = .41) or slope change (-0.66/1000 person-years [95% CI, -1.59 to 0.27]; P = .16). The level (1.64/1000 person-years [95% CI, -4.83 to 8.11]; P = .61) and slope (-0.23/1000 person-years [95% CI, -1.17 to0.70]; P = .61) changes in the postintervention period were not significantly different compared with the intervention period. The baseline rate of serious hyperglycemia was 22.33 per 1000 person-years (95% CI, 12.70-31.97). For the rate of serious hyperglycemic events, there was no significant association between the start of the intervention and a level (4.23/1000 person-years [95% CI, -8.62 to 17.08]; P = .51) or slope (-0.51/1000 person-years [95% CI, -2.37 to 1.34]; P = .58) change.CONCLUSIONS AND RELEVANCE Among Medicare beneficiaries with type 2 diabetes, implementation of a health plan program that involved switching patients from analogue to human insulin was associated with a small increase in population-level HbA(1c).