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
{"title":"Continuous Glucose Monitoring Provides Durable Glycemic Benefit in Adolescents and Young Adults with Type 1 Diabetes: 12-Month Follow-Up Results","authors":"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","doi":"10.1155/2023/6718115","DOIUrl":null,"url":null,"abstract":"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 ( <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. 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.","PeriodicalId":19797,"journal":{"name":"Pediatric Diabetes","volume":"27 1","pages":"0"},"PeriodicalIF":3.9000,"publicationDate":"2023-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric Diabetes","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1155/2023/6718115","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
引用次数: 0
Abstract
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 ( ); 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 ( ). 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 ( ) and mean TIR increased from 34% ± 12% to 38% ± 15% ( ). The median percent time <70 mg/dL decreased from 3.3% before CGM initiation to 1.2% after 26 weeks of CGM use ( ). 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.
期刊介绍:
Pediatric Diabetes is a bi-monthly journal devoted to disseminating new knowledge relating to the epidemiology, etiology, pathogenesis, management, complications and prevention of diabetes in childhood and adolescence. The aim of the journal is to become the leading vehicle for international dissemination of research and practice relating to diabetes in youth. Papers are considered for publication based on the rigor of scientific approach, novelty, and importance for understanding mechanisms involved in the epidemiology and etiology of this disease, especially its molecular, biochemical and physiological aspects. Work relating to the clinical presentation, course, management and outcome of diabetes, including its physical and emotional sequelae, is considered. In vitro studies using animal or human tissues, whole animal and clinical studies in humans are also considered. The journal reviews full-length papers, preliminary communications with important new information, clinical reports, and reviews of major topics. Invited editorials, commentaries, and perspectives are a regular feature. The editors, based in the USA, Europe, and Australasia, maintain regular communications to assure rapid turnaround time of submitted manuscripts.