1 型糖尿病成人低血糖高风险者中从瞬感血糖仪切换至连续血糖监测：I HART CGM 研究扩展阶段。
Switching from Flash Glucose Monitoring to Continuous Glucose Monitoring on Hypoglycemia in Adults with Type 1 Diabetes at High Hypoglycemia Risk: The Extension Phase of the I HART CGM Study.
机构信息
Division of Diabetes, Endocrinology and Metabolism, Imperial College , London, United Kingdom .
出版信息
Diabetes Technol Ther. 2018 Nov;20(11):751-757. doi: 10.1089/dia.2018.0252. Epub 2018 Sep 28.
BACKGROUND
The I HART CGM study showed that real-time continuous glucose monitoring (RT-CGM) has greater beneficial impact on hypoglycemia than intermittent flash glucose monitoring (flash) in adults with type 1 diabetes (T1D) at high risk. The impact of continuing RT-CGM or switching from flash to RT-CGM for another 8 weeks was then evaluated.
METHODS
Prospective randomized parallel group study with an extension phase. After a 2-week run-in with blinded CGM, participants were randomized to either RT-CGM or flash for 8 weeks. All participants were then given the option to continue with RT-CGM for another 8 weeks. Glycemic outcomes at 8 weeks are compared with the 16-week endpoint.
RESULTS
Forty adults with T1D on intensified multiple daily insulin injections and with impaired awareness of hypoglycemia or a recent episode of severe hypoglycemia were included (40% female, median [IQR] age 49.5 [37.5-63.5] years, diabetes duration 30.0 [21.0-36.5] years, HbA1c 56 [48-63] mmol/mol, and Gold Score 5 [4-5]), of whom 36 completed the final 16-week extension. There was a significant reduction in percentage time in hypoglycemia (<3.0 mmol/L) in the group switching from flash to RT-CGM (from 5.0 [3.7-8.6]% to 0.8 [0.4-1.9]%, P = 0.0001), whereas no change was observed in the RT-CGM group continuing with the additional 8 weeks of RT-CGM (1.3 [0.4-2.8] vs. 1.3 [0.8-2.5], P = 0.82). Time in target (3.9-10 mmol/L) increased in the flash group after switching to RT-CGM (60.0 [54.5-67.8] vs. 67.4 [56.3-72.4], P = 0.02) and remained the same in the RT-CGM group that continued with RT-CGM (65.9 [54.1-74.8] vs. 64.9 [49.2-73.9], P = 0.64).
CONCLUSIONS
Our data suggest that switching from flash to RT-CGM has a significant beneficial impact on hypoglycemia outcomes and that continued use of RT-CGM maintains hypoglycemia risk benefit in this high-risk population.
背景
I HART CGM 研究表明，实时连续血糖监测（RT-CGM）在高风险的 1 型糖尿病（T1D）成人中，相较于间歇性闪光血糖监测（flash），对低血糖的有益影响更大。然后评估了继续使用 RT-CGM 或从 flash 切换到 RT-CGM 再持续 8 周的效果。
方法
这是一项前瞻性随机平行组研究，具有扩展阶段。在进行为期 2 周的盲法 CGM 监测后，参与者被随机分配到 RT-CGM 或 flash 组，进行 8 周的监测。所有参与者都可以选择再继续使用 RT-CGM 监测 8 周。8 周的血糖结果与 16 周的终点进行比较。
结果
研究纳入了 40 名接受强化多次每日胰岛素注射且有低血糖感知障碍或近期严重低血糖发作的 T1D 成人（女性占 40%，中位[四分位距]年龄 49.5[37.5-63.5]岁，糖尿病病程 30.0[21.0-36.5]年，HbA1c 56[48-63]mmol/mol，Gold 评分 5[4-5]），其中 36 名患者完成了最终的 16 周扩展。与继续使用 RT-CGM 监测的患者相比，从 flash 切换到 RT-CGM 监测的患者的低血糖时间百分比（<3.0mmol/L）显著降低（从 5.0[3.7-8.6]%降至 0.8[0.4-1.9]%，P=0.0001），而继续使用 RT-CGM 监测的患者的 RT-CGM 组中，低血糖时间百分比无变化（1.3[0.4-2.8] vs. 1.3[0.8-2.5]，P=0.82）。在切换到 RT-CGM 后，flash 组的目标血糖时间（3.9-10mmol/L）增加（60.0[54.5-67.8] vs. 67.4[56.3-72.4]，P=0.02），而继续使用 RT-CGM 监测的 RT-CGM 组的目标血糖时间不变（65.9[54.1-74.8] vs. 64.9[49.2-73.9]，P=0.64）。
结论
我们的数据表明，从 flash 切换到 RT-CGM 对低血糖结局有显著的有益影响，并且在高危人群中继续使用 RT-CGM 维持低血糖风险获益。
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