Division of Endocrinology and Center for Diabetes Technology, University of Virginia, Charlottesville, VA.
Jaeb Center for Health Research, Tampa, FL.
Diabetes Care. 2020 Aug;43(8):1822-1828. doi: 10.2337/dc20-0124. Epub 2020 May 29.
Limited information is available about glycemic outcomes with a closed-loop control (CLC) system compared with a predictive low-glucose suspend (PLGS) system.
After 6 months of use of a CLC system in a randomized trial, 109 participants with type 1 diabetes (age range, 14-72 years; mean HbA, 7.1% [54 mmol/mol]) were randomly assigned to CLC ( = 54, Control-IQ) or PLGS ( = 55, Basal-IQ) groups for 3 months. The primary outcome was continuous glucose monitor (CGM)-measured time in range (TIR) for 70-180 mg/dL. Baseline CGM metrics were computed from the last 3 months of the preceding study.
All 109 participants completed the study. Mean ± SD TIR was 71.1 ± 11.2% at baseline and 67.6 ± 12.6% using intention-to-treat analysis (69.1 ± 12.2% using per-protocol analysis excluding periods of study-wide suspension of device use) over 13 weeks on CLC vs. 70.0 ± 13.6% and 60.4 ± 17.1% on PLGS (difference = 5.9%; 95% CI 3.6%, 8.3%; < 0.001). Time >180 mg/dL was lower in the CLC group than PLGS group (difference = -6.0%; 95% CI -8.4%, -3.7%; < 0.001) while time <54 mg/dL was similar (0.04%; 95% CI -0.05%, 0.13%; = 0.41). HbA after 13 weeks was lower on CLC than PLGS (7.2% [55 mmol/mol] vs. 7.5% [56 mmol/mol], difference -0.34% [-3.7 mmol/mol]; 95% CI -0.57% [-6.2 mmol/mol], -0.11% [1.2 mmol/mol]; = 0.0035).
Following 6 months of CLC, switching to PLGS reduced TIR and increased HbA toward their pre-CLC values, while hypoglycemia remained similarly reduced with both CLC and PLGS.
与预测性低血糖暂停(PLGS)系统相比,闭环控制系统(CLC)的血糖控制结果信息有限。
在一项随机试验中使用 CLC 系统 6 个月后,109 名 1 型糖尿病患者(年龄 14-72 岁;平均 HbA1c 为 7.1%[54mmol/mol])被随机分为 CLC 组(n=54,Control-IQ)或 PLGS 组(n=55,Basal-IQ),治疗 3 个月。主要结局是连续血糖监测(CGM)测量的 70-180mg/dL 时间范围内(TIR)。基线 CGM 指标是在前一研究的最后 3 个月计算得出的。
所有 109 名参与者均完成了研究。在 CLC 治疗 13 周时,基于意向治疗分析的平均±SD TIR 为 71.1±11.2%(基于方案分析的 TIR 为 69.1±12.2%,排除了研究期间设备使用暂停的所有时间段),而使用 PLGS 时为 70.0±13.6%和 60.4±17.1%(差值=5.9%;95%CI 3.6%,8.3%;<0.001)。与 PLGS 组相比,CLC 组的血糖>180mg/dL 时间更低(差值=-6.0%;95%CI-8.4%,-3.7%;<0.001),而血糖<54mg/dL 时间相似(差值=0.04%;95%CI-0.05%,0.13%;=0.41)。13 周时,CLC 组的 HbA1c 低于 PLGS 组(7.2%[55mmol/mol] vs. 7.5%[56mmol/mol],差值-0.34%[-3.7mmol/mol];95%CI-0.57%[-6.2mmol/mol],-0.11%[1.2mmol/mol];=0.0035)。
在使用 CLC 6 个月后,切换至 PLGS 会降低 TIR 并使 HbA1c 恢复到使用 CLC 之前的值,同时使用 CLC 和 PLGS 仍可同样减少低血糖。