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8 results on '"Real-world observational studies"'

1. Reductions in HbA1c with Flash Glucose Monitoring Are Sustained for up to 24 Months: A Meta-Analysis of 75 Real-World Observational Studies.

Author

Evans, Mark, Welsh, Zoë, and Seibold, Alexander

Subjects
*GLYCOSYLATED hemoglobin, *TYPE 1 diabetes, *RANDOM effects model, *TYPE 2 diabetes, *SCIENTIFIC observation
Abstract

Introduction: Real-world evidence (RWE) confirms that reductions in HbA1c for children and adults with type 1 diabetes (T1DM) and adults with type 2 diabetes (T2DM) are associated with use of the FreeStyle Libre system. This current meta-analysis aims to investigate whether HbA1c benefits are sustained over 24 months and to identify patterns of change in HbA1c for users of the FreeStyle Libre system for people living with T1DM or T2DM. Methods: A bibliographic search up to December 2020 identified 75 studies reporting data on change in lab HbA1c in 30,478 participants with type 1 (n = 28,063; 62 trials) or type 2 diabetes (n = 2415; 13 trials) using the FreeStyle Libre system, including observations on children, adolescents and adults. Meta-analysis was performed using a random effects model. Results: Reductions in HbA1c at 3–4 months were similar for adults with T1DM (− 0.53%, 95% CI − 0.69 to − 0.38) or with T2DM (− 0.45%, 95% CI − 0.57 to − 0.33), continuing through 4.5–7.5 months in T1DM (− 0.42%, 95% CI − 0.58 to − 0.27) and in T2DM (− 0.59%, 95% CI − 0.80 to − 0.39). Meta-regression analysis shows that higher starting HbA1c is correlated with greater reductions in HbA1c in T1DM and in T2DM. These patterns of change in HbA1c were sustained for 24 months in T1DM and for at least 12 months in T2DM. Conclusions: Meta-analysis of RWE confirms that using the FreeStyle Libre system is associated with significant reductions in HbA1c for adults with T1DM or with T2DM. Reductions are greater for people with higher baseline HbA1c and are sustained for 24 and 12 months in T1DM and TD2M respectively. [ABSTRACT FROM AUTHOR]

Published
2022
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2. The Impact of Flash Glucose Monitoring on Glycaemic Control as Measured by HbA1c: A Meta-analysis of Clinical Trials and Real-World Observational Studies.

Author

Evans, Mark, Welsh, Zoë, Ells, Sara, and Seibold, Alexander

Subjects
*META-analysis, *TYPE 1 diabetes, *GLUCOSE, *SCIENTIFIC observation, *TYPE 2 diabetes
Abstract

Introduction: Glycated haemoglobin A1c (HbA1c) is the established standard measurement for assessment of glycaemic control in people with diabetes. Here we report on a meta-analysis of real-world observational studies on the impact of flash continuous glucose monitoring on glycaemic control as measured by HbA1c. Methods: A total of 271 studies were identified in our search, of which 29 contained data reporting changes in HbA1c over periods from 1 to 24 months that could be used in a statistical analysis. Our meta-analysis focuses on observed change in HbA1c at either 2, 3 or 4 months, in adult or paediatric subjects, as well as a longitudinal analysis up to 12 months in adult subjects. These data were drawn from 25 of the studies identified in our initial search. These reported HbA1c data up to 12 months in a total of 1723 participants with type 1 diabetes (T1D) or type 2 diabetes (T2D) using the FreeStyle Libre® flash glucose monitoring system. Results: Overall mean change in laboratory HbA1c across study subjects at 2–4 months was − 0.55% (95% CI − 0.70, − 0.39). Amongst the 1023 adults, mean change in HbA1c was − 0.56% (95% CI − 0.76, − 0.36); for the 447 children and adolescents, mean change in HbA1c was − 0.54% (95% CI − 0.84, − 0.23). Based on regression analysis, the degree of change in HbA1c correlated with the initial HbA1c of the study population. A longitudinal analysis in adult subjects (n = 1276) shows that HbA1c fell within the first 2 months and changes were sustained up to 12 months. No significant differences were detected between T1D and T2D. Conclusion: The meta-analysis reported here confirms that starting the FreeStyle Libre system as part of diabetes care results in a significant and sustained reduction in HbA1c for adults and children with T1D and for adults with T2D. Funding: Abbott Diabetes Care. [ABSTRACT FROM AUTHOR]

Published
2020
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3. The Impact of Flash Glucose Monitoring on Glycaemic Control as Measured by HbA1c: A Meta-analysis of Clinical Trials and Real-World Observational Studies

Author

Alexander Seibold, Zoe K. Welsh, Mark L. Evans, Sara Ells, Apollo - University of Cambridge Repository, and Evans, Mark [0000-0001-8122-8987]

Subjects
medicine.medical_specialty, HbA1c, endocrine system diseases, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, 03 medical and health sciences, Flash glucose monitoring, 0302 clinical medicine, Internal medicine, Diabetes mellitus, Internal Medicine, Medicine, Data reporting, Real-world observational studies, Original Research, Continuous glucose monitoring (CGM), Interstitial fluid, Continuous glucose monitoring, business.industry, Self-monitoring blood glucose (SMBG), nutritional and metabolic diseases, Regression analysis, medicine.disease, 3. Good health, Clinical trial, Meta-analysis, Population study, Observational study, business
Abstract

Introduction: Glycated haemoglobin A1c (HbA1c) is the established standard measurement for assessment of glycaemic control in people with diabetes. Here we report on a meta-analysis of real-world observational studies on the impact of flash continuous glucose monitoring on glycaemic control as measured by HbA1c. Methods: A total of 271 studies were identified in our search, of which 29 contained data reporting changes in HbA1c over periods from 1 to 24 months that could be used in a statistical analysis. Our meta-analysis focuses on observed change in HbA1c at either 2, 3 or 4 months, in adult or paediatric subjects, as well as a longitudinal analysis up to 12 months in adult subjects. These data were drawn from 25 of the studies identified in our initial search. These reported HbA1c data up to 12 months in a total of 1723 participants with type 1 diabetes (T1D) or type 2 diabetes (T2D) using the FreeStyle Libre® flash glucose monitoring system. Results: Overall mean change in laboratory HbA1c across study subjects at 2–4 months was − 0.55% (95% CI − 0.70, − 0.39). Amongst the 1023 adults, mean change in HbA1c was − 0.56% (95% CI − 0.76, − 0.36); for the 447 children and adolescents, mean change in HbA1c was − 0.54% (95% CI − 0.84, − 0.23). Based on regression analysis, the degree of change in HbA1c correlated with the initial HbA1c of the study population. A longitudinal analysis in adult subjects (n = 1276) shows that HbA1c fell within the first 2 months and changes were sustained up to 12 months. No significant differences were detected between T1D and T2D. Conclusion: The meta-analysis reported here confirms that starting the FreeStyle Libre system as part of diabetes care results in a significant and sustained reduction in HbA1c for adults and children with T1D and for adults with T2D. Funding: Abbott Diabetes Care.

Published
2019

4. Comparative effectiveness of indacaterol/glycopyrronium in the treatment of chronic obstructive pulmonary disease

Author

Mario Cazzola and Paola Rogliani

Subjects
medicine.medical_specialty, Settore MED/10 - Malattie dell'Apparato Respiratorio, Comparative effectiveness research, Pulmonary disease, Muscarinic Antagonists, Quinolones, law.invention, glycopyrronium, 03 medical and health sciences, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Randomized controlled trial, law, Adrenal Cortex Hormones, indacaterol, medicine, Humans, 030212 general & internal medicine, Intensive care medicine, Randomized Controlled Trials as Topic, fixed-dose combinations, biology, business.industry, Health Policy, comparative effectiveness research, pragmatic randomized controlled trials, randomized controlled trials, real-world observational studies, Muscarinic antagonist, Lama, biology.organism_classification, Glycopyrrolate, Bronchodilator Agents, Clinical Practice, Drug Combinations, Observational Studies as Topic, Treatment Outcome, 030228 respiratory system, Indans, Indacaterol, Observational study, business, medicine.drug
Abstract

Indacaterol/glycopyrronium has been the first long-acting β 2 -agonist (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combination to be approved as a maintenance treatment in chronic obstructive pulmonary disease patients. Comparative effectiveness studies indicate that it is constantly superior to a LAMA or a LABA alone or even a LABA/inhaled corticosteroid combination, regardless of the drugs used. However, definitive data documenting the benefit of indacaterol/glycopyrronium fixed-dose combination over these consolidated therapies are still absent in a real-world setting, although the results of pivotal randomized controlled trials show that this is the case. Therefore, in addition to the large body of evidence already available supporting the use of indacaterol/glycopyrronium, pragmatic observational studies or ad hoc designed trials should be planned to collect data that could confirm the high effectiveness of indacaterol/glycopyrronium even in the real-life clinical practice.

Published
2017

5. Comparative effectiveness of indacaterol/glycopyrronium in the treatment of chronic obstructive pulmonary disease.

Author

Cazzola M and Rogliani P

Subjects
Adrenal Cortex Hormones therapeutic use, Comparative Effectiveness Research, Drug Combinations, Humans, Observational Studies as Topic, Randomized Controlled Trials as Topic, Treatment Outcome, Bronchodilator Agents therapeutic use, Glycopyrrolate therapeutic use, Indans therapeutic use, Muscarinic Antagonists therapeutic use, Pulmonary Disease, Chronic Obstructive drug therapy, Quinolones therapeutic use
Abstract

Indacaterol/glycopyrronium has been the first long-acting β 2 -agonist (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combination to be approved as a maintenance treatment in chronic obstructive pulmonary disease patients. Comparative effectiveness studies indicate that it is constantly superior to a LAMA or a LABA alone or even a LABA/inhaled corticosteroid combination, regardless of the drugs used. However, definitive data documenting the benefit of indacaterol/glycopyrronium fixed-dose combination over these consolidated therapies are still absent in a real-world setting, although the results of pivotal randomized controlled trials show that this is the case. Therefore, in addition to the large body of evidence already available supporting the use of indacaterol/glycopyrronium, pragmatic observational studies or ad hoc designed trials should be planned to collect data that could confirm the high effectiveness of indacaterol/glycopyrronium even in the real-life clinical practice.

Published
2017
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6. The Impact of Flash Glucose Monitoring on Glycaemic Control as Measured by HbA1c: A Meta-analysis of Clinical Trials and Real-World Observational Studies

Author

Evans, Mark, Welsh, Zoë, Ells, Sara, and Seibold, Alexander

Subjects
Continuous glucose monitoring (CGM), Flash glucose monitoring, Interstitial fluid, Meta-analysis, HbA1c, endocrine system diseases, Self-monitoring blood glucose (SMBG), nutritional and metabolic diseases, Real-world observational studies, 3. Good health
Abstract

INTRODUCTION: Glycated haemoglobin A1c (HbA1c) is the established standard measurement for assessment of glycaemic control in people with diabetes. Here we report on a meta-analysis of real-world observational studies on the impact of flash continuous glucose monitoring on glycaemic control as measured by HbA1c. METHODS: A total of 271 studies were identified in our search, of which 29 contained data reporting changes in HbA1c over periods from 1 to 24 months that could be used in a statistical analysis. Our meta-analysis focuses on observed change in HbA1c at either 2, 3 or 4 months, in adult or paediatric subjects, as well as a longitudinal analysis up to 12 months in adult subjects. These data were drawn from 25 of the studies identified in our initial search. These reported HbA1c data up to 12 months in a total of 1723 participants with type 1 diabetes (T1D) or type 2 diabetes (T2D) using the FreeStyle Libre® flash glucose monitoring system. RESULTS: Overall mean change in laboratory HbA1c across study subjects at 2-4 months was - 0.55% (95% CI - 0.70, - 0.39). Amongst the 1023 adults, mean change in HbA1c was - 0.56% (95% CI - 0.76, - 0.36); for the 447 children and adolescents, mean change in HbA1c was - 0.54% (95% CI - 0.84, - 0.23). Based on regression analysis, the degree of change in HbA1c correlated with the initial HbA1c of the study population. A longitudinal analysis in adult subjects (n = 1276) shows that HbA1c fell within the first 2 months and changes were sustained up to 12 months. No significant differences were detected between T1D and T2D. CONCLUSION: The meta-analysis reported here confirms that starting the FreeStyle Libre system as part of diabetes care results in a significant and sustained reduction in HbA1c for adults and children with T1D and for adults with T2D. FUNDING: Abbott Diabetes Care.

7. The Impact of Flash Glucose Monitoring on Glycaemic Control as Measured by HbA1c: A Meta-analysis of Clinical Trials and Real-World Observational Studies

Author

Evans, Mark, Welsh, Zoë, Ells, Sara, and Seibold, Alexander

Subjects
Continuous glucose monitoring (CGM), Flash glucose monitoring, Interstitial fluid, Meta-analysis, HbA1c, Self-monitoring blood glucose (SMBG), Real-world observational studies, 3. Good health, Original Research
Abstract

Funder: Abbott Diabetes Care; doi: http://dx.doi.org/10.13039/100011946, Introduction: Glycated haemoglobin A1c (HbA1c) is the established standard measurement for assessment of glycaemic control in people with diabetes. Here we report on a meta-analysis of real-world observational studies on the impact of flash continuous glucose monitoring on glycaemic control as measured by HbA1c. Methods: A total of 271 studies were identified in our search, of which 29 contained data reporting changes in HbA1c over periods from 1 to 24 months that could be used in a statistical analysis. Our meta-analysis focuses on observed change in HbA1c at either 2, 3 or 4 months, in adult or paediatric subjects, as well as a longitudinal analysis up to 12 months in adult subjects. These data were drawn from 25 of the studies identified in our initial search. These reported HbA1c data up to 12 months in a total of 1723 participants with type 1 diabetes (T1D) or type 2 diabetes (T2D) using the FreeStyle Libre® flash glucose monitoring system. Results: Overall mean change in laboratory HbA1c across study subjects at 2–4 months was − 0.55% (95% CI − 0.70, − 0.39). Amongst the 1023 adults, mean change in HbA1c was − 0.56% (95% CI − 0.76, − 0.36); for the 447 children and adolescents, mean change in HbA1c was − 0.54% (95% CI − 0.84, − 0.23). Based on regression analysis, the degree of change in HbA1c correlated with the initial HbA1c of the study population. A longitudinal analysis in adult subjects (n = 1276) shows that HbA1c fell within the first 2 months and changes were sustained up to 12 months. No significant differences were detected between T1D and T2D. Conclusion: The meta-analysis reported here confirms that starting the FreeStyle Libre system as part of diabetes care results in a significant and sustained reduction in HbA1c for adults and children with T1D and for adults with T2D. Funding: Abbott Diabetes Care.

8. The Impact of Flash Glucose Monitoring on Glycaemic Control as Measured by HbA1c: A Meta-analysis of Clinical Trials and Real-World Observational Studies

Author

Evans, Mark, Welsh, Zoë, Ells, Sara, and Seibold, Alexander

Subjects
Continuous glucose monitoring (CGM), Flash glucose monitoring, Interstitial fluid, Meta-analysis, HbA1c, Self-monitoring blood glucose (SMBG), Real-world observational studies, 3. Good health, Original Research
Abstract

Funder: Abbott Diabetes Care; doi: http://dx.doi.org/10.13039/100011946, Introduction: Glycated haemoglobin A1c (HbA1c) is the established standard measurement for assessment of glycaemic control in people with diabetes. Here we report on a meta-analysis of real-world observational studies on the impact of flash continuous glucose monitoring on glycaemic control as measured by HbA1c. Methods: A total of 271 studies were identified in our search, of which 29 contained data reporting changes in HbA1c over periods from 1 to 24 months that could be used in a statistical analysis. Our meta-analysis focuses on observed change in HbA1c at either 2, 3 or 4 months, in adult or paediatric subjects, as well as a longitudinal analysis up to 12 months in adult subjects. These data were drawn from 25 of the studies identified in our initial search. These reported HbA1c data up to 12 months in a total of 1723 participants with type 1 diabetes (T1D) or type 2 diabetes (T2D) using the FreeStyle Libre® flash glucose monitoring system. Results: Overall mean change in laboratory HbA1c across study subjects at 2–4 months was − 0.55% (95% CI − 0.70, − 0.39). Amongst the 1023 adults, mean change in HbA1c was − 0.56% (95% CI − 0.76, − 0.36); for the 447 children and adolescents, mean change in HbA1c was − 0.54% (95% CI − 0.84, − 0.23). Based on regression analysis, the degree of change in HbA1c correlated with the initial HbA1c of the study population. A longitudinal analysis in adult subjects (n = 1276) shows that HbA1c fell within the first 2 months and changes were sustained up to 12 months. No significant differences were detected between T1D and T2D. Conclusion: The meta-analysis reported here confirms that starting the FreeStyle Libre system as part of diabetes care results in a significant and sustained reduction in HbA1c for adults and children with T1D and for adults with T2D. Funding: Abbott Diabetes Care.

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