The GenoDiabMar registry. A collaborative research platform of "real world" type 2 diabetes patients.

The GenoDiabMar registry is a prospective study aims to provide data on demographic, biochemical and clinical changes, from a real-world population of Type 2 DM (T2D) patients. This registry is addressed to find new biomarkers related to the micro and macrovascular complications of T2D, especially focused on diabetic nephropathy. The registry includes longitudinal serum and urine samples, DNA bank, as well as data on 227 metabolomics profiles, 77 Immunoglobulin G glycomics traits and others emerging biomarkers. 650 patients aged 69.56 +/- 9.31 with different grades of chronic kidney disease; (G1-2 50.3%, G3 31.4%, G4 10.8% and G5 7.5%) were followed up for 4.96 (+/-0.43) years. Regardless of albuminuria, women lost 0.93 (0.40-1.46) glomerular filtration units per year less than men. 17% of the participant experienced rapid progression of renal function, 75.2% men, with differential risk factors between sexes; severe macroalbuminuria >300mg/g for men OR[IQ] 2.40 [1.29:4.44] and concomitant peripheral vascular disease 3.32 [1.10:9.57] for women. An overall mortality of 23% was detected (38% due to Cardiovascular aetiology). This cohort is postulated as a great tool for scientific collaboration for studies, whether they are focused on T2D, or whether they are interested in comparing differential markers between diabetic and non-diabetic populations

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Clinical evaluation of type 2 disease status in a real‐world population of difficult to manage asthma using historic electronic healthcare records of blood eosinophil counts

Clinical & Experimental Allergy ◽

10.1111/cea.13841 ◽

2021 ◽

Author(s):

Adnan Azim ◽

Colin Newell ◽

Clair Barber ◽

Matthew Harvey ◽

Deborah Knight ◽

...

Keyword(s):

Clinical Evaluation ◽

Real World ◽

Disease Status ◽

Blood Eosinophil ◽

World Population ◽

Eosinophil Counts

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Effect of Diabetes Treatment-Related Attributes on Costs to Type 2 Diabetes Patients in a Real-World Population

Journal of Managed Care & Specialty Pharmacy ◽

10.18553/jmcp.2017.23.4.446 ◽

2017 ◽

Vol 23 (4) ◽

pp. 446-452 ◽

Cited By ~ 5

Author(s):

Jie Meng ◽

Roman Casciano ◽

Yi-Chien Lee ◽

Lee Stern ◽

Dmitry Gultyaev ◽

...

Keyword(s):

Type 2 Diabetes ◽

Real World ◽

World Population ◽

Diabetes Treatment ◽

Diabetes Patients

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A Distribution-based Method for Assessing The Differences between Clinical Trial Target Populations and Patient Populations in Electronic Health Records

Applied Clinical Informatics ◽

10.4338/aci-2013-12-ra-0105 ◽

2014 ◽

Vol 05 (02) ◽

pp. 463-479 ◽

Cited By ~ 30

Author(s):

P. Ryan ◽

Y. Zhang ◽

F. Liu ◽

J. Gao ◽

J.T. Bigger ◽

...

Keyword(s):

Type 2 Diabetes ◽

Clinical Trial ◽

Clinical Trials ◽

Electronic Health Records ◽

Real World ◽

World Population ◽

Health Records ◽

Target Populations ◽

Electronic Health

SummaryObjective: To improve the transparency of clinical trial generalizability and to illustrate the method using Type 2 diabetes as an example.Methods: Our data included 1,761 diabetes clinical trials and the electronic health records (EHR) of 26,120 patients with Type 2 diabetes who visited Columbia University Medical Center of New-York Presbyterian Hospital. The two populations were compared using the Generalizability Index for Study Traits (GIST) on the earliest diagnosis age and the mean hemoglobin A1c (HbA1c) values.Results: Greater than 70% of Type 2 diabetes studies allow patients with HbA1c measures between 7 and 10.5, but less than 40% of studies allow HbA1c<7 and fewer than 45% of studies allow HbA1c>10.5. In the real-world population, only 38% of patients had HbA1c between 7 and 10.5, with 12% having values above the range and 52% having HbA1c<7. The GIST for HbA1c was 0.51. Most studies adopted broad age value ranges, with the most common restrictions excluding patients >80 or <18 years. Most of the real-world population fell within this range, but 2% of patients were <18 at time of first diagnosis and 8% were >80. The GIST for age was 0.75. Conclusions: We contribute a scalable method to profile and compare aggregated clinical trial target populations with EHR patient populations. We demonstrate that Type 2 diabetes studies are more generalizable with regard to age than they are with regard to HbA1c. We found that the generalizability of age increased from Phase 1 to Phase 3 while the generalizability of HbA1c decreased during those same phases. This method can generalize to other medical conditions and other continuous or binary variables. We envision the potential use of EHR data for examining the generaliz-ability of clinical trials and for defining population-representative clinical trial eligibility criteria.Citation: Weng C, Li Y, Ryan P, Zhang Y, Liu F, Gao J, Bigger JT, Hripcsak G. A distribution-based method for assessing the differences between clinical trial target populations and patient populations in electronic health records. Appl Clin Inf 2014; 5: 463–479 http://dx.doi.org/10.4338/ACI-2013-12-RA-0105

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Rates of glycaemic deterioration in a real-world population with type 2 diabetes

Diabetologia ◽

10.1007/s00125-017-4519-5 ◽

2017 ◽

Vol 61 (3) ◽

pp. 607-615 ◽

Cited By ~ 19

Author(s):

Louise A. Donnelly ◽

Kaixin Zhou ◽

Alex S. F. Doney ◽

Chris Jennison ◽

Paul W. Franks ◽

...

Keyword(s):

Type 2 Diabetes ◽

Real World ◽

World Population

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CVOTs applicability on SGLT-2i in a real world population of type 2 diabetes patients

The Journal of AMD ◽

10.36171/jamd19.22.1-2.02 ◽

2019 ◽

Vol 22 (1-2) ◽

pp. 6

Author(s):

Manicardi, V.

Keyword(s):

Type 2 Diabetes ◽

Real World ◽

World Population ◽

Eligibility Criteria ◽

The Real ◽

Major Cardiovascular Events ◽

Cerebrovascular Events ◽

Glomerular Filtrate ◽

Design And Methods

OBJECTIVE OF THE STUDY To evaluate the generalizability of the results of recent CVOTs on SGLT2i (EMPA-REG OUTCOMES, CANVAS, DECLARE-TIMI 58 and VERTIS-CV) in patients with T2DM in the real world. DESIGN AND METHODS Database of AMD Annals 2018 was used in this study, including all patients cared for by 222 diabetes centers during 2016. Starting from the eligibility criteria adopted in the different trials, the analysis aimed to identify the subjects potentially eligible for each trial, compare their characteristics with those of the population recruited in the trials, and evaluate the current use of these drugs among the potentially eligible patients registered in AMD Annals database. RESULTS The evaluable cases (i.e. presence of information on all eligibility criteria) ranged from 149.064 for the CANVAS to the 342.205 subjects for the EMPAREG-OUTCOME. Overall, the eligible patients in AMD Annals ranged from 40,039 for the EMPAREG OUTCOME study (11.7%) to 144,166 (55.9%) for DECLARE-TIMI 58. The percentage of patients actually treated ranged from 4.4% (6.373) for DECLARE-TIMI 58 to 6.6% (2.917) for CANVAS. As compared to RCTs’ populations, AMD Annals population was older, included a larger proportion of women, showed slightly lower BMI and better metabolic control, and longer diabetes duration. Prevalence of major cardio-cerebrovascular events was lower, while the percentage of subjects with peripheral vasculopathy was higher; the proportion of subjects with reduced glomerular filtrate or albuminuria and diabetic retinopathy was higher. CONCLUSIONS The generalizability of CVOTs’ results to the real world patients is only partial, because the populations are quite different. A very low clinical use of SGLT-2i is documented. This is at least in part due to the strict AIFA criteria for reimbursement, which reduce the proportion of patients who could benefit from treatment with SGLT2i on major cardiovascular events and mortality; however, an identical advantage of the treatment obtained in RCTs cannot be hypothesized in the AMD Annals population. KEY WORDS type 2 diabetes; CVOT; real world; generalizability; SGLT2i

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Risk of anaemia with metformin use in type 2 diabetes: A MASTERMIND study

10.2337/figshare.12678368.v1 ◽

2020 ◽

Author(s):

Louise A Donnelly ◽

John M Dennis ◽

Ruth L Coleman ◽

Naveed Sattar ◽

Andrew T Hattersley ◽

...

Keyword(s):

Type 2 Diabetes ◽

Real World ◽

Time Course ◽

Controlled Trial ◽

Vitamin B12 Deficiency ◽

Population Data ◽

World Population ◽

Metformin Group ◽

Randomised Controlled

Objective: To evaluate the association between metformin use and anaemia risk in type 2 diabetes, and the time-course for this, in randomised controlled trial (RCT) and real-world population data. Research design and methods: Anaemia was defined as a haemoglobin measure less than 11g/dL. In RCTs (ADOPT (n=3,967), UKPDS (n=1,473)), logistic regression was used to model anaemia risk and non-linear mixed models for change in haematological parameters.In the observational GoDARTS population (n=3,485), discrete-time failure analysis was used to model the effect of cumulative metformin exposure on anaemia risk. Results: In ADOPT, compared with sulfonylureas, the odds ratio(OR)(95%CI) for anaemia was 1.93(1.10,3.38) for metformin and 4.18(2.50,7.00) for thiazolidinediones. In UKPDS, compared with diet, the OR(95%CI) was 3.40(1.98,5.83) for metformin, 0.96(0.57,1.62) for sulfonylureas and 1.08(0.62,1.87) for insulin. In ADOPT, haemoglobin and haematocrit dropped following metformin initiation by six months, with no further decrease after three years. In UKPDS, haemoglobin fell by three years in the metformin group compared to other treatments. At years six and nine, haemoglobin was reduced in all treatment groups, with no greater difference seen in the metformin group. In GoDARTS, each 1g/day of metformin use was associated with a 2% higher annual risk of anaemia. Conclusions: Metformin use is associated with early risk of anaemia in individuals with type 2 diabetes, a finding consistent across two RCTs and replicated in one real-world study. The mechanism for this early fall in haemoglobin is uncertain, but given the time course is unlikely to be due to vitamin B12 deficiency alone.

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