Miller Kellee M, Kanapka Lauren G, Rickels Michael R, Ahmann Andrew J, Aleppo Grazia, Ang Lynn, Bhargava Anuj, Bode Bruce W, Carlson Anders, Chaytor Naomi S, Gannon Gail, Goland Robin, Hirsch Irl B, Kiblinger Lisa, Kruger Davida, Kudva Yogish C, Levy Carol J, McGill Janet B, O'Malley Grenye, Peters Anne L, Philipson Louis H, Philis-Tsimikas Athena, Pop-Busui Rodica, Salam Maamoun, Shah Viral N, Thompson Michael J, Vendrame Francesco, Verdejo Alandra, Weinstock Ruth S, Young Laura, Pratley Richard
Jaeb Center for Health Research, Tampa, Florida, USA.
Rodebaugh Diabetes Center, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Diabetes Technol Ther. 2022 Jun;24(6):424-434. doi: 10.1089/dia.2021.0503. Epub 2022 Apr 11.
To evaluate glycemic outcomes in the Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) randomized clinical trial (RCT) participants during an observational extension phase. WISDM RCT was a 26-week RCT comparing continuous glucose monitoring (CGM) with blood glucose monitoring (BGM) in 203 adults aged ≥60 years with type 1 diabetes. Of the 198 participants who completed the RCT, 100 (98%) CGM group participants continued CGM (CGM-CGM cohort) and 94 (98%) BGM group participants initiated CGM (BGM-CGM cohort) for an additional 26 weeks. CGM was used a median of >90% of the time at 52 weeks in both cohorts. In the CGM-CGM cohort, median time <70 mg/dL decreased from 5.0% at baseline to 2.6% at 26 weeks and remained stable with a median of 2.8% at 52 weeks ( < 0.001 baseline to 52 weeks). Participants spent more time in range 70-180 mg/dL (TIR) (mean 56% vs. 64%; < 0.001) and had lower hemoglobin A1c (HbA1c) (mean 7.6% [59 mmol/mol] vs. 7.4% [57 mmol/mol]; = 0.01) from baseline to 52 weeks. In BGM-CGM, from 26 to 52 weeks median time <70 mg/dL decreased from 3.9% to 1.9% ( < 0.001), TIR increased from 56% to 60% ( = 0.006) and HbA1c decreased from 7.5% (58 mmol/mol) to 7.3% (57 mmol/mol) ( = 0.025). In BGM-CGM, a severe hypoglycemic event was reported for nine participants while using BGM during the RCT and for two participants during the extension phase with CGM ( = 0.02). CGM use reduced hypoglycemia without increasing hyperglycemia in older adults with type 1 diabetes. These data provide further evidence for fully integrating CGM into clinical practice. Clinicaltrials.gov (NCT03240432).
为了评估糖尿病老年患者无线创新(WISDM)随机临床试验(RCT)参与者在观察性延长期的血糖结果。WISDM RCT是一项为期26周的RCT,比较了203名年龄≥60岁的1型糖尿病成年人的持续葡萄糖监测(CGM)与血糖监测(BGM)。在完成RCT的198名参与者中,100名(98%)CGM组参与者继续使用CGM(CGM-CGM队列),94名(98%)BGM组参与者开始使用CGM(BGM-CGM队列),持续另外26周。在两个队列中,52周时CGM的使用时间中位数均>90%。在CGM-CGM队列中,血糖<70mg/dL的中位时间从基线时的5.0%降至26周时的2.6%,并在52周时保持稳定,中位数为2.8%(从基线到52周,<0.001)。从基线到52周,参与者处于70-180mg/dL范围内的时间(TIR)更长(平均56%对64%;<0.001),糖化血红蛋白(HbA1c)更低(平均7.6%[59mmol/mol]对7.4%[57mmol/mol];=0.01)。在BGM-CGM队列中,从26周到52周,血糖<70mg/dL的中位时间从3.9%降至1.9%(<0.001),TIR从56%增加到60%(=0.006),HbA1c从7.5%(58mmol/mol)降至7.3%(57mmol/mol)(=0.025)。在BGM-CGM队列中,有9名参与者在RCT期间使用BGM时报告了严重低血糖事件,2名参与者在CGM延长期报告了严重低血糖事件(=0.02)。在1型糖尿病老年患者中,使用CGM可降低低血糖风险,且不会增加高血糖风险。这些数据为将CGM全面纳入临床实践提供了进一步证据。Clinicaltrials.gov(NCT03240432)。