Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials.
Roy W. Beck,Richard M. Bergenstal,Tonya D Riddlesworth,Craig Kollman,Zhaomian Li,Adam S. Brown,Kelly L. Close +6 more
TLDR
A compelling case can be made that TIR is strongly associated with the risk of microvascular complications and should be an acceptable end point for clinical trials.Abstract:
OBJECTIVE This study evaluated the association of time in range (TIR) of 70–180 mg/dL (3.9–10 mmol/L) with the development or progression of retinopathy and development of microalbuminuria using the Diabetes Control and Complications (DCCT) data set in order to validate the use of TIR as an outcome measure for clinical trials. RESEARCH DESIGN AND METHODS In the DCCT, blood glucose concentrations were measured at a central laboratory from seven fingerstick samples (seven-point testing: pre- and 90-min postmeals and at bedtime) collected during 1 day every 3 months. Retinopathy progression was assessed every 6 months and urinary microalbuminuria development every 12 months. Proportional hazards models were used to assess the association of TIR and other glycemic metrics, computed from the seven-point fingerstick data, with the rate of development of microvascular complications. RESULTS Mean TIR of seven-point profiles for the 1,440 participants was 41 ± 16%. The hazard rate of development of retinopathy progression was increased by 64% (95% CI 51–78), and development of the microalbuminuria outcome was increased by 40% (95% CI 25–56) for each 10 percentage points lower TIR ( P CONCLUSIONS Based on these results, a compelling case can be made that TIR is strongly associated with the risk of microvascular complications and should be an acceptable end point for clinical trials. Although hemoglobin A 1c remains a valuable outcome metric in clinical trials, TIR and other glycemic metrics—especially when measured with continuous glucose monitoring—add value as outcome measures in many studies.read more
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Journal ArticleDOI
Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range
Tadej Battelino,Thomas Danne,Richard M. Bergenstal,Stephanie A. Amiel,Roy W. Beck,Torben Biester,Emanuele Bosi,Bruce A. Buckingham,William T. Cefalu,Kelly L. Close,Claudio Cobelli,Eyal Dassau,J. Hans DeVries,Kim C. Donaghue,Klemen Dovc,Francis J. Doyle,Satish K. Garg,George Grunberger,Simon Heller,Lutz Heinemann,Irl B. Hirsch,Roman Hovorka,Weiping Jia,Olga Kordonouri,Boris Kovatchev,Aaron J. Kowalski,Lori M. Laffel,Brian J. Levine,Alexander Mayorov,Chantal Mathieu,Helen R. Murphy,Revital Nimri,Kirsten Nørgaard,Christopher G. Parkin,Eric Renard,David Rodbard,Banshi Saboo,Desmond A. Schatz,Keaton C. Stoner,Tatsuiko Urakami,Stuart A. Weinzimer,Moshe Phillip,Moshe Phillip +42 more
TL;DR: This article summarizes the ATTD consensus recommendations for relevant aspects of CGM data utilization and reporting among the various diabetes populations.
Journal ArticleDOI
KDIGO 2020 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease
Ian H. de Boer,M. Luiza Caramori,Juliana C.N. Chan,Hiddo J.L. Heerspink,Clint Hurst,Kamlesh Khunti,Adrian Liew,Erin D. Michos,Sankar D. Navaneethan,Wasiu A Olowu,Tami Sadusky,Nikhil Tandon,Katherine R. Tuttle,Christoph Wanner,Katy G. Wilkens,Sophia Zoungas,Peter Rossing +16 more
Journal ArticleDOI
The Relationship of Hemoglobin A1C to Time-in-Range in Patients with Diabetes.
TL;DR: There is a good correlation between HbA1C and %TIR that may permit the transition to %T IR as the preferred metric for determining the outcome of clinical studies, predicting of the risk of diabetes complications, and assessing of an individual patient's glycemic control.
Journal ArticleDOI
The Relationships Between Time in Range, Hyperglycemia Metrics, and HbA1c.
Roy W. Beck,Richard M. Bergenstal,Peiyao Cheng,Craig Kollman,Anders L. Carlson,Mary L. Johnson,David Rodbard +6 more
TL;DR: In T1D, CGM measures reflecting hyperglycemia (including TIR and mean glucose) are highly correlated with each other but only moderately correlated with A1C.
Journal ArticleDOI
A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial.
Richard M. Bergenstal,Revital Nimri,Roy W. Beck,Amy Criego,Lori M. Laffel,Desmond A. Schatz,Tadej Battelino,Thomas Danne,Stuart A. Weinzimer,Judy Sibayan,Mary L. Johnson,Ryan Bailey,Peter Calhoun,Anders L. Carlson,Elvira Isganaitis,Rachel Bello,Anastasia Albanese-O'Neill,Klemen Dovc,Torben Biester,Kate Weyman,Korey K. Hood,Moshe Phillip +21 more
TL;DR: In this article, the authors compared outcomes using a commercially available hybrid closed-loop system versus a new investigational system with features potentially useful for adolescents and young adults with type 1 diabetes.
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Diabetes Control,David M. Nathan,Saul M. Genuth,John M. Lachin,Patricia A. Cleary,O Crofford,Matthew M. Davis,Larry Rand,Carolyn Siebert +8 more
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Thomas Danne,Revital Nimri,Tadej Battelino,Richard M. Bergenstal,Kelly L. Close,J. Hans DeVries,Satish K. Garg,Lutz Heinemann,Irl B. Hirsch,Stephanie A. Amiel,Roy W. Beck,Emanuele Bosi,Bruce A. Buckingham,Claudio Cobelli,Eyal Dassau,Francis J. Doyle,Simon Heller,Roman Hovorka,Weiping Jia,Timothy W. Jones,Olga Kordonouri,Boris P. Kovatchev,Aaron J. Kowalski,Lori M.B. Laffel,David M. Maahs,Helen R. Murphy,Kirsten Nørgaard,Christopher G. Parkin,Eric Renard,Banshi Saboo,Mauro Scharf,William V. Tamborlane,Stuart A. Weinzimer,Moshe Phillip +33 more
TL;DR: This article summarizes the ATTD consensus recommendations and represents the current understanding of how CGM results can affect outcomes.
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The Effect of Glucose Variability on the Risk of Microvascular Complications in Type 1 Diabetes
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Journal ArticleDOI
The effect of glucose variability on the risk of microvascular complications in type 1 diabetes.
Irl B. Hirsch,Michael Brownlee +1 more
TL;DR: The analysis of seven-point glucose profiles reported in this study suggested that glucose variability is not an independent risk factor for microvascular complications, but the seven- point profile may not be an accurate representation of true glycemic variability as measured by continuous blood glucose monitoring.
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