Department of Medical Psychology, VU University Medical Center, Amsterdam, the Netherlands.
EMGO+ Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands.
Diabetes Care. 2016 Dec;39(12):2190-2196. doi: 10.2337/dc16-1614. Epub 2016 Oct 20.
To establish the effectiveness of a brief, partly web-based group intervention, HypoAware, in patients with problematic hypoglycemia, in terms of the reduction of severe hypoglycemic episodes, impaired hypoglycemia awareness, and worries.
A two-arm, cluster randomized controlled trial was conducted in insulin-treated patients with problematic hypoglycemia in eight Dutch clinics comparing HypoAware with care as usual. Primary outcomes included self-reported severe hypoglycemia, impaired hypoglycemia awareness (Gold score), and worries and distress about hypoglycemia (Hypoglycemia Fear Survey-II/Problem Areas In Diabetes scale hypo-item), assessed at baseline, and at 2, 4, and 6 months of follow-up. We used t tests, nonparametric tests, and intention-to-treat generalized estimation equation (GEE) analyses with linear, logistic, and Poisson or negative binomial models.
We enrolled 137 participants. Adjusted GEE analyses over four time points showed a nonsignificant 33% fewer episodes of severe hypoglycemia in the HypoAware group compared with the control group (relative risk [RR] 0.67 [95% CI 0.39-1.16], P = 0.150); a significant reduced odds of impaired awareness (odds ratio 0.38 [95% CI 0.15-0.95], P = 0.038), a trend toward 20% fewer worries about hypoglycemia (RR 0.80 [95% CI 0.64-1.01], P = 0.059), and a significant 30% less hypo-distress (RR 0.70 [95% CI 0.56-0.88], P = 0.002). Over the 6-month study duration, participants experienced a median of 2.5 events of severe hypoglycemia (interquartile range [IQR] 1-10) in the control condition versus 1 event (IQR 0-6.5) in the HypoAware group (P = 0.030). There was no significant change in HbA level within and between both groups.
HypoAware resulted in fewer severe hypoglycemic episodes, significantly improved hypoglycemia awareness, and less hypo-distress in comparison with usual care, and deserves further dissemination.
评估 HypoAware 这一简短的、部分基于网络的团体干预措施在有问题的低血糖患者中的有效性，从减少严重低血糖发作、改善低血糖意识和减轻相关担忧这三个方面进行评估。
本研究为一项在荷兰 8 家诊所开展的、针对胰岛素治疗的有问题低血糖患者的、双臂、集群随机对照试验，将 HypoAware 与常规护理进行比较。主要结局包括在基线时以及在 2、4 和 6 个月的随访中，自我报告的严重低血糖、低血糖意识受损（Gold 评分）以及对低血糖的担忧和困扰（低血糖恐惧调查 II/糖尿病问题区域量表中的低血糖条目）。我们使用 t 检验、非参数检验和意向治疗广义估计方程（GEE）分析，采用线性、逻辑和泊松或负二项模型。
我们共纳入了 137 名参与者。在四个时间点进行调整后的 GEE 分析显示，与对照组相比，HypoAware 组严重低血糖发作的次数减少了 33%（相对风险 [RR] 0.67 [95% CI 0.39-1.16]，P = 0.150）；低血糖意识受损的几率显著降低（比值比 [OR] 0.38 [95% CI 0.15-0.95]，P = 0.038），对低血糖的担忧减少了 20%（RR 0.80 [95% CI 0.64-1.01]，P = 0.059），低血糖困扰减少了 30%（RR 0.70 [95% CI 0.56-0.88]，P = 0.002），均具有统计学意义。在 6 个月的研究期间，对照组参与者经历的严重低血糖发作中位数为 2.5 次（四分位距 [IQR] 1-10），而 HypoAware 组为 1 次（IQR 0-6.5）（P = 0.030）。两组患者的 HbA1c 水平在治疗期间和治疗后均无显著变化。
与常规护理相比，HypoAware 可减少严重低血糖发作，显著改善低血糖意识，并减轻低血糖困扰，值得进一步推广。
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