持续血糖监测为1型糖尿病青少年和年轻人提供持久的血糖益处:12个月的随访结果

IF 4.3 3区 材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC ACS Applied Electronic Materials Pub Date : 2023-10-26 DOI:10.1155/2023/6718115
Kellee M. Miller, Colleen Bauza, Lauren G. Kanapka, Mark A. Clements, Daniel J. DeSalvo, Korey Hood, Laurel H. Messer, Jennifer Sherr, Katherine Bergamo, Amy Criego, Emily Freiner, Sarah K. Lyons, Roshanak Monzavi, Wayne Moore, Priya Prahalad, Jill H. Simmons, Mark Sulik, R. Paul Wadwa, Ruth S. Weinstock, Steven M. Willi, Kristen Williams, Lori M. Laffel
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Following a 26-week RCT comparing CGM with blood glucose monitoring (BGM) in 153 adolescents and young adults aged 14 to <25 years old with suboptimally controlled type 1 diabetes, 70 (89%) participants in the BGM group initiated use of CGM (referred to as BGM–CGM cohort), and 70 (95%) participants in the CGM group continued to use of CGM (CGM–CGM cohort) for an additional 26 weeks. Results. In the CGM–CGM cohort, mean hemoglobin A1c (HbA1c) decreased from 8.9% ± 0.9% (74 ± 9.8 mmol/mol) at randomization to 8.3% ± 1.3% (67 ± 14.2 mmol/mol) at 52 weeks ( <math xmlns=\"http://www.w3.org/1998/Math/MathML\" id=\"M1\"> <mi>p</mi> <mo><</mo> <mn>0.001</mn> </math> ); however, significant improvement in time in target range (TIR) 70–180 mg/dL was not observed from prerandomization (38% ± 13%) to 52 weeks (41% ± 18%). Median percent time <70 mg/dL decreased from 3.0% before randomization to 1.1% at 52 weeks ( <math xmlns=\"http://www.w3.org/1998/Math/MathML\" id=\"M2\"> <mi>p</mi> <mo><</mo> <mn>0.001</mn> </math> ). In the BGM–CGM cohort, mean HbA1c decreased from 8.9% ± 1.2% (74 ± 13.1 mmol/mol) before CGM initiation to 8.5% ± 1.3% (69 ± 14.2 mmol/mol) after 26 weeks of CGM use ( <math xmlns=\"http://www.w3.org/1998/Math/MathML\" id=\"M3\"> <mi>p</mi> <mo><</mo> <mn>0.001</mn> </math> ) and mean TIR increased from 34% ± 12% to 38% ± 15% ( <math xmlns=\"http://www.w3.org/1998/Math/MathML\" id=\"M4\"> <mi>p</mi> <mo>=</mo> <mn>0.01</mn> </math> ). The median percent time <70 mg/dL decreased from 3.3% before CGM initiation to 1.2% after 26 weeks of CGM use ( <math xmlns=\"http://www.w3.org/1998/Math/MathML\" id=\"M5\"> <mi>p</mi> <mo><</mo> <mn>0.001</mn> </math> ). No participants discontinued CGM use during the extension phase. Conclusions. 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引用次数: 0

摘要

目标。为了进一步评估青少年和年轻人连续血糖监测(CGM)干预随机临床试验(RCT)观察延长阶段的血糖结局。研究对象和方法。在一项为期26周的RCT研究中,153名年龄在14岁至25岁、患有控制不理想的1型糖尿病的青少年和年轻人将CGM与血糖监测(BGM)进行了比较,BGM组中有70名(89%)参与者开始使用CGM(称为BGM - CGM队列),CGM组中有70名(95%)参与者继续使用CGM (CGM - CGM队列)额外26周。结果。在CGM-CGM队列中,平均血红蛋白A1c (HbA1c)从随机分组时的8.9%±0.9%(74±9.8 mmol/mol)下降到52周时的8.3%±1.3%(67±14.2 mmol/mol) (p <0.001);然而,从随机化前(38%±13%)到52周(41%±18%),在目标范围(TIR) 70-180 mg/dL的时间上没有观察到显著改善。70 mg/dL的中位时间百分比从随机化前的3.0%下降到52周时的1.1% (p <0.001)。在BGM-CGM队列中,平均HbA1c从CGM开始前的8.9%±1.2%(74±13.1 mmol/mol)下降到使用CGM 26周后的8.5%±1.3%(69±14.2 mmol/mol) (p <0.001),平均TIR从34%±12%上升到38%±15% (p = 0.01)。70 mg/dL的中位百分比时间从CGM开始前的3.3%下降到使用CGM 26周后的1.2% (p <0.001)。没有参与者在扩展阶段停止使用CGM。结论。这项对CGM的进一步评估支持了之前的随机对照试验的发现,即使用CGM可以改善青少年和年轻1型糖尿病患者的血糖控制并降低低血糖。本试验注册号为NCT03263494。
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Continuous Glucose Monitoring Provides Durable Glycemic Benefit in Adolescents and Young Adults with Type 1 Diabetes: 12-Month Follow-Up Results
Objective. To further evaluate glycemic outcomes during the observational extension phase of the Continuous Glucose Monitoring (CGM) Intervention for Teens and Young Adults randomized clinical trial (RCT). Subjects and Methods. Following a 26-week RCT comparing CGM with blood glucose monitoring (BGM) in 153 adolescents and young adults aged 14 to <25 years old with suboptimally controlled type 1 diabetes, 70 (89%) participants in the BGM group initiated use of CGM (referred to as BGM–CGM cohort), and 70 (95%) participants in the CGM group continued to use of CGM (CGM–CGM cohort) for an additional 26 weeks. Results. In the CGM–CGM cohort, mean hemoglobin A1c (HbA1c) decreased from 8.9% ± 0.9% (74 ± 9.8 mmol/mol) at randomization to 8.3% ± 1.3% (67 ± 14.2 mmol/mol) at 52 weeks ( p < 0.001 ); however, significant improvement in time in target range (TIR) 70–180 mg/dL was not observed from prerandomization (38% ± 13%) to 52 weeks (41% ± 18%). Median percent time <70 mg/dL decreased from 3.0% before randomization to 1.1% at 52 weeks ( p < 0.001 ). In the BGM–CGM cohort, mean HbA1c decreased from 8.9% ± 1.2% (74 ± 13.1 mmol/mol) before CGM initiation to 8.5% ± 1.3% (69 ± 14.2 mmol/mol) after 26 weeks of CGM use ( p < 0.001 ) and mean TIR increased from 34% ± 12% to 38% ± 15% ( p = 0.01 ). The median percent time <70 mg/dL decreased from 3.3% before CGM initiation to 1.2% after 26 weeks of CGM use ( p < 0.001 ). No participants discontinued CGM use during the extension phase. Conclusions. This further evaluation of CGM supports the findings of the preceding RCT that use of CGM improves glycemic control and reduces hypoglycemia in adolescents and young adults with type 1 diabetes. This trial is registered with NCT03263494.
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