glucose

Importance: Type 2 diabetes involves progressive loss of insulin secretion from pancreatic β cells in the setting of insulin resistance and manifests clinically as hyperglycemia. Type 2 diabetes accounts for 90% to 95% of all cases of diabetes globally, with estimates ranging from 589 million to 828 million people worldwide. In the US, type 2 diabetes affects approximately 1 in 6 adults.

Observations: Risk factors for type 2 diabetes include older age, family history, overweight or obesity, physical inactivity, gestational diabetes, Hispanic ethnicity, and American Indian or Alaska Native, Asian, or Black race. Diabetes is diagnosed if fasting plasma glucose is greater than or equal to 126 mg/dL, hemoglobin A1C is greater than or equal to 6.5%, or 2-hour glucose during 75-g oral glucose tolerance testing is greater than or equal to 200 mg/dL. Approximately one-third of adults with type 2 diabetes have cardiovascular disease and 10.1% have severe vision difficulty or blindness. The prevalence of type 2 diabetes is 39.2% among patients with kidney failure. Although weight management is an important component of treatment for type 2 diabetes, no specific diet has been proven to be most effective for improving health outcomes. Physical activity can reduce hemoglobin A1C by 0.4% to 1.0% and improve cardiovascular risk factors (ie, hypertension and dyslipidemia). Randomized clinical trials have reported absolute reductions in microvascular disease (3.5%), such as retinopathy and nephropathy, myocardial infarction (3.3%-6.2%), and mortality (2.7%-4.9%), with intensive glucose-lowering strategies (hemoglobin A1C <7%) vs conventional treatment 2 decades after trial completion. First-line medications for type 2 diabetes include metformin and, in patients with cardiovascular or kidney comorbidities or at high cardiovascular risk, glucagon-like peptide-1 receptor agonists (GLP-1RAs) or sodium-glucose cotransporter 2 inhibitors (SGLT2is). Common add-on medications include dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1RAs, dipeptidyl peptidase-4 inhibitors, sulfonylureas, and thiazolidinediones. Approximately one-third of patients with type 2 diabetes require treatment with insulin during their lifetime. Several randomized clinical trials have demonstrated benefits of specific SGLT2i and GLP-1RA medications compared with placebo for atherosclerotic cardiovascular disease (12%-26% risk reduction), heart failure (18%-25% risk reduction), and kidney disease (24%-39% risk reduction) over 2 to 5 years. Most trial participants with type 2 diabetes were taking metformin. High-potency GLP-1RA and dual GIP/GLP-1RA medications result in weight loss of greater than 5% in most individuals with type 2 diabetes, and weight loss may exceed 10%.

Conclusions: Type 2 diabetes affects up to 14% of the global population and is associated with preventable long-term complications, such as cardiovascular disease, kidney failure, vision loss, and increased mortality. In addition to lifestyle modifications including diet, exercise, and weight management, metformin is generally first-line therapy for attainment of hemoglobin A1C targets. For individuals with type 2 diabetes and cardiovascular or kidney disease or at high cardiovascular risk, guidelines recommend early treatment with SGLT2i and/or GLP-1RA medications.

Author/s:

Rita R Kalyani, Joshua J Neumiller, Nisa M Maruthur, Deborah J Wexler

Comparative Effects of Glucose-Lowering Medications on Kidney Outcomes in Type 2 Diabetes The GRADE Randomized Clinical Trial

Aubrey Delammermore — Sat, 27 May 2023 05:00:00 +0000

Date Added:

May 27, 2023

Journal/Publication:

JAMA

Publisher:

American Medical Association

Publication Date:

May 22, 2023

Pages:

E1-E10

URL:

Comparative Effects of Glucose-Lowering Medications on Kidney Outcomes in Type 2 Diabetes The GRADE Randomized Clinical Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jamainternmed.2023.1487

Keywords

Intention to Treat Analysis

PMID (1):

37213109

MeSH

Disease Progression

Kidney Diseases

renal dialysis

diabetes mellitus, type 2

glucose

In patients with T2DM, if your objective is to protect the kidneys, there is no need to switch to newer, more expensive meds. James W. Mold, MD, MPH.

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Importance: Type 2 diabetes (T2D) is the leading cause of kidney disease in the US. It is not known whether glucose-lowering medications differentially affect kidney function.

Objective: To evaluate kidney outcomes in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) trial comparing 4 classes of glucose-lowering medications added to metformin for glycemic management in individuals with T2D.

Design, setting, and participants: A randomized clinical trial was conducted at 36 sites across the US. Participants included adults with T2D for less than 10 years, a hemoglobin A1c level between 6.8% and 8.5%, and estimated glomerular filtration rate (eGFR) greater than or equal to 60 mL/min/1.73 m2 who were receiving metformin treatment. A total of 5047 participants were enrolled between July 8, 2013, and August 11, 2017, and followed up for a mean of 5.0 years (range, 0-7.6 years). Data were analyzed from February 21, 2022, to March 27, 2023.

Interventions: Addition of insulin glargine, glimepiride, liraglutide, or sitagliptin to metformin, with the medication combination continued until the HbA1c was greater than 7.5%; thereafter, insulin was added to maintain glycemic control.

Main outcomes and measures: Chronic eGFR slope (change in eGFR between year 1 and trial end) and a composite kidney disease progression outcome (albuminuria, dialysis, transplant, or death due to kidney disease). Secondary outcomes included incident eGFR less than 60 mL/min/1.73 m2, 40% decrease in eGFR to less than 60 mL/min/1.73 m2, doubling of urine albumin-to-creatinine ratio (UACR) to 30 mg/g or greater, and progression of Kidney Disease Improving Global Outcomes stage. Analyses were intention-to-treat.

Results: Of the 5047 participants, 3210 (63.6%) were men. Baseline characteristics were mean (SD) age 57.2 (10.0) years; HbA1c 7.5% (0.5%); diabetes duration, 4.2 (2.7) years; body mass index, 34.3 (6.8); blood pressure 128.3/77.3 (14.7/9.9) mm Hg; eGFR 94.9 (16.8) mL/min/1.73 m2; and median UACR, 6.4 (IQR 3.1-16.9) mg/g; 2933 (58.1%) were treated with renin-angiotensin-aldosterone inhibitors. Mean chronic eGFR slope was -2.03 (95% CI, -2.20 to -1.86) mL/min/1.73 m2 per year for patients receiving sitagliptin; glimepiride, -1.92 (95% CI, -2.08 to -1.75) mL/min/1.73 m2 per year; liraglutide, -2.08 (95% CI, -2.26 to -1.90) mL/min/1.73 m2 per year; and insulin glargine, -2.02 (95% CI, -2.19 to -1.84) mL/min/1.73 m2 per year (P = .61). Mean composite kidney disease progression occurred in 135 (10.6%) patients receiving sitagliptin; glimepiride, 155 (12.4%); liraglutide, 152 (12.0%); and insulin glargine, 150 (11.9%) (P = .56). Most of the composite outcome was attributable to albuminuria progression (98.4%). There were no significant differences by treatment assignment in secondary outcomes. There were no adverse kidney events attributable to medication assignment.

Conclusions and relevance: In this randomized clinical trial, among people with T2D and predominantly free of kidney disease at baseline, no significant differences in kidney outcomes were observed during 5 years of follow-up when a dipeptidyl peptidase 4 inhibitor, sulfonylurea, glucagonlike peptide 1 receptor agonist, or basal insulin was added to metformin for glycemic control.

Author/s:

Wexler, D. J., de Boer, I. H., Ghosh, A., Younes, N., Bebu, I., Inzucchi, S. E., McGill, J. B., Mudaliar, S., Schade, D., Steffes, M., Tamborlane, W. V., Tan, M. H., Ismail-Beigi, F., GRADE Research Group

Vitamin D and Risk for Type 2 Diabetes in People With Prediabetes : A Systematic Review and Meta-analysis of Individual Participant Data From 3 Randomized Clinical Trials

Aubrey Delammermore — Thu, 23 Feb 2023 06:00:00 +0000

Date Added:

February 23, 2023

Journal/Publication:

Annals of Internal Medicine

Publisher:

American College of Physicians

Publication Date:

February 7, 2023

URL:

Vitamin D and Risk for Type 2 Diabetes in People With Prediabetes : A Systematic Review and Meta-analysis of Individual Participant Data From 3 Randomized Clinical Trials

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

0.7326/M22-3018

Keywords

Kidney

Cholecalciferol

Intention to Treat Analysis

type 2 diabetes

Randomized Controlled Trials as Topic

PMID (1):

36745886

MeSH

diabetes mellitus, type 2

In patients with prediabetes, Vitamin D supplementation appears to improve blood glucose levels and reduce progression to diabetes. James W. Mold, MD, MPH

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Background: The role of vitamin D in people who are at risk for type 2 diabetes remains unclear.

Purpose: To evaluate whether administration of vitamin D decreases risk for diabetes among people with prediabetes.

Data sources: PubMed, Embase, and ClinicalTrials.gov from database inception through 9 December 2022.

Study selection: Eligible trials that were specifically designed and conducted to test the effects of oral vitamin D versus placebo on new-onset diabetes in adults with prediabetes.

Data extraction: The primary outcome was time to event for new-onset diabetes. Secondary outcomes were regression to normal glucose regulation and adverse events. Prespecified analyses (both unadjusted and adjusted for key baseline variables) were conducted according to the intention-to-treat principle.

Data synthesis: Three randomized trials were included, which tested cholecalciferol, 20 000 IU (500 mcg) weekly; cholecalciferol, 4000 IU (100 mcg) daily; or eldecalcitol, 0.75 mcg daily, versus matching placebos. Trials were at low risk of bias. Vitamin D reduced risk for diabetes by 15% (hazard ratio, 0.85 [95% CI, 0.75 to 0.96]) in adjusted analyses, with a 3-year absolute risk reduction of 3.3% (CI, 0.6% to 6.0%). The effect of vitamin D did not differ in prespecified subgroups. Among participants assigned to the vitamin D group who maintained an intratrial mean serum 25-hydroxyvitamin D level of at least 125 nmol/L (≥50 ng/mL) compared with 50 to 74 nmol/L (20 to 29 ng/mL) during follow-up, cholecalciferol reduced risk for diabetes by 76% (hazard ratio, 0.24 [CI, 0.16 to 0.36]), with a 3-year absolute risk reduction of 18.1% (CI, 11.7% to 24.6%). Vitamin D increased the likelihood of regression to normal glucose regulation by 30% (rate ratio, 1.30 [CI, 1.16 to 1.46]). There was no evidence of difference in the rate ratios for adverse events (kidney stones: 1.17 [CI, 0.69 to 1.99]; hypercalcemia: 2.34 [CI, 0.83 to 6.66]; hypercalciuria: 1.65 [CI, 0.83 to 3.28]; death: 0.85 [CI, 0.31 to 2.36]).

Limitations: Studies of people with prediabetes do not apply to the general population. Trials may not have been powered for safety outcomes.

Conclusion: In adults with prediabetes, vitamin D was effective in decreasing risk for diabetes.

Primary funding source: None. (PROSPERO: CRD42020163522).

Author/s:

Pittas, A. G., Kawahara, T., Jorde, R., Dawson-Hughes, B., Vickery, E. M., Angellotti, E., Nelson, J., Trikalinos, T. A., Balk, E. M.

Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial

Saige Blanchard — Tue, 08 Jun 2021 05:00:00 +0000

Date Added:

June 8, 2021

Journal/Publication:

Journal of the American Medical Association

Publisher:

American Medical Association

Publication Date:

June 8, 2021

Issue:

Volume:

325

Pages:

2262-2272

URL:

Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial

Format:

Article

DOI (1):

10.1001/jama.2021.7444

Keywords

PMID (1):

34077499

MeSH

glycated hemoglobin a

Use of continuous glucose monitoring devices by people with Type 2 diabetes who are being treated with supplementary basal insulin results in significantly better glycemic control. James W. Mold, MD, MPH

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Importance: Continuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy, but its use in type 2 diabetes treated with basal insulin without prandial insulin has not been well studied.

Objective: To determine the effectiveness of CGM in adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices.

Design, setting, and participants: This randomized clinical trial was conducted at 15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications.

Interventions: Random assignment 2:1 to CGM (n = 116) or traditional blood glucose meter (BGM) monitoring (n = 59).

Main outcomes and measures: The primary outcome was hemoglobin A1c (HbA1c) level at 8 months. Key secondary outcomes were CGM-measured time in target glucose range of 70 to 180 mg/dL, time with glucose level at greater than 250 mg/dL, and mean glucose level at 8 months.

Results: Among 175 randomized participants (mean [SD] age, 57 [9] years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4% [95% CI, -0.8% to -0.1%]; P = .02). In the CGM group, compared with the BGM group, the mean percentage of CGM-measured time in the target glucose range of 70 to 180 mg/dL was 59% vs 43% (adjusted difference, 15% [95% CI, 8% to 23%]; P < .001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, -16% [95% CI, -21% to -11%]; P < .001), and the means of the mean glucose values were 179 mg/dL vs 206 mg/dL (adjusted difference, -26 mg/dL [95% CI, -41 to -12]; P < .001). Severe hypoglycemic events occurred in 1 participant (1%) in the CGM group and in 1 (2%) in the BGM group.

Conclusions and relevance: Among adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin, continuous glucose monitoring, as compared with blood glucose meter monitoring, resulted in significantly lower HbA1c levels at 8 months.

Author/s:

Martens, T., Beck, R. W., Bailey, R., Ruedy, K. J., Calhoun, P., Peters, A. L., Pop-Busui, R., Philis-Tsimikas, A., Bao, S., Umpierrez, G., Davis, G., Kruger, D., Bhargava, A., Young, L., McGill, J. B., Aleppo, G., Nguyen, Q. T., Orozco, I., Biggs, W., Lucas, K. J., Polonsky, W. H., Buse, J. B., Price, D., Bergenstal, R. M.

Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial

Brian Desmarais — Wed, 13 May 2020 23:54:05 +0000

Date Added:

May 13, 2020

Journal/Publication:

Annals of Family Medicine

Publication Date:

May 1, 2020

Issue:

Volume:

Pages:

235-242

URL:

Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1370/afm.2520

MeSH

Personal Satisfaction

In this relatively small RCT, prolotherapy was more effective than saline injections for relieving pain and improving function in patients with OA of the knee at 4, 6, and 12 months. James W. Mold, MD, MPH

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Purpose: To test the efficacy of intra-articular hypertonic dextrose prolotherapy (DPT) vs normal saline (NS) injection for knee osteoarthritis (KOA).

Methods: A single-center, parallel-group, blinded, randomized controlled trial was conducted at a university primary care clinic in Hong Kong. Patients with KOA (n = 76) were randomly allocated (1:1) to DPT or NS groups for injections at weeks 0, 4, 8, and 16. The primary outcome was the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 0-100 points) pain score. The secondary outcomes were the WOMAC composite, function and stiffness scores; objectively assessed physical function test results; visual analogue scale (VAS) for knee pain; and EuroQol-5D score. All outcomes were evaluated at baseline and at 16, 26, and 52 weeks using linear mixed model.

Results: Randomization produced similar groups. The WOMAC pain score at 52 weeks showed a difference-in-difference estimate of -10.34 (95% CI, -19.20 to -1.49, P = 0.022) points. A similar favorable effect was shown on the difference-in-difference estimate on WOMAC function score of -9.55 (95% CI, -17.72 to -1.39, P = 0.022), WOMAC composite score of -9.65 (95% CI, -17.77 to -1.53, P = 0.020), VAS pain intensity score of -10.98 (95% CI, -21.36 to -0.61, P = 0.038), and EuroQol-5D VAS score of 8.64 (95% CI, 1.36 to 5.92, P = 0.020). No adverse events were reported.

Conclusion: Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections. The procedure is straightforward and safe; the adherence and satisfaction were high.

Keywords: intra-articular hypertonic dextrose; knee osteoarthritis; normal saline; prolotherapy; randomized clinical trial.

Author/s:

Sit, R.W.S., Wu, R.W., Reeves, K.D., Chan, D.C.C., Yip, B.H.K., Chung, V.C.H., Wong, S.

Summary of Revisions: Standards of Medical Care in Diabetes—2020

John Bayhi — Sat, 14 Mar 2020 19:35:38 +0000

Date Added:

March 14, 2020

Journal/Publication:

Diabetes Care

Publisher:

American Diabetes Association

Publication Date:

January 1, 2020

Issue:

Supplement 1

Volume:

Pages:

S4-S6

URL:

Summary of Revisions: Standards of Medical Care in Diabetes—2020

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.2337/dc20-Srev

Keywords

PMID (1):

31862743

MeSH

Sodium-Glucose Transporter 2 Inhibitors

Diabetic Ketoacidosis

Ficus

Glucagon-Like Peptide-1 Receptor

glycated hemoglobin a

cardiovascular diseases

Consensus

Farmers

Cystic Fibrosis

Transients and Migrants

Pharmaceutical Preparations

depression

Smell

Patient Comfort

electronic nicotine delivery systems

Blood Glucose Self-Monitoring

celiac disease

follow-up studies

Latent Autoimmune Diabetes in Adults

seasons

social determinants of health

Standard of Care

Time-to-Treatment

united states food and drug administration

risk reduction behavior

Centers for Disease Control and Prevention

glucagon-like peptide 1

anxiety disorders

Feeding and Eating Disorders

thyroid diseases

Infections

This is a three-page summary of the 2020 updates to the ADA Guidelines for Type 2 diabetes. James W. Mold, MD, MPH

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No abstract available.

Intensive Glucose Control in Patients with Type 2 Diabetes — 15-Year Follow-up

Brian Desmarais — Mon, 10 Jun 2019 14:27:35 +0000

Date Added:

June 10, 2019

Journal/Publication:

New England Journal of Medicine

Publication Date:

June 6, 2019

Issue:

Volume:

380

Pages:

2215-2224

URL:

Intensive Glucose Control in Patients with Type 2 Diabetes — 15-Year Follow-up

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa1806802.

Keywords

MeSH

glycated hemoglobin a

myocardial infarction

stroke

heart failure

amputation

diabetes mellitus, type 2

Intensive management of glucose levels in patients with Type 2 DM does not extend life. This is not new news, but it is a reminder that the benefit of treatment of Type 2 DM is improved quality of life, primarily fewer symptoms and a reduced risk of future microvascular problems, though those problems are relatively uncommon even without treatment.

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BACKGROUND

We previously reported that a median of 5.6 years of intensive as compared with standard glucose lowering in 1791 military veterans with type 2 diabetes resulted in a risk of major cardiovascular events that was significantly lower (by 17%) after a total of 10 years of combined intervention and observational follow-up. We now report the full 15-year follow-up.

METHODS

We observationally followed enrolled participants (complete cohort) after the conclusion of the original clinical trial by using central databases to identify cardiovascular events, hospitalizations, and deaths. Participants were asked whether they would be willing to provide additional data by means of surveys and chart reviews (survey cohort). The prespecified primary outcome was a composite of major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, new or worsening congestive heart failure, amputation for ischemic gangrene, and death from cardiovascular causes. Death from any cause was a prespecified secondary outcome.

RESULTS

There were 1655 participants in the complete cohort and 1391 in the survey cohort. During the trial (which originally enrolled 1791 participants), the separation of the glycated hemoglobin curves between the intensive-therapy group (892 participants) and the standard-therapy group (899 participants) averaged 1.5 percentage points, and this difference declined to 0.2 to 0.3 percentage points by 3 years after the trial ended. Over a period of 15 years of follow-up (active treatment plus post-trial observation), the risks of major cardiovascular events or death were not lower in the intensive-therapy group than in the standard-therapy group (hazard ratio for primary outcome, 0.91; 95% confidence interval [CI], 0.78 to 1.06; P=0.23; hazard ratio for death, 1.02; 95% CI, 0.88 to 1.18). The risk of major cardiovascular disease outcomes was reduced, however, during an extended interval of separation of the glycated hemoglobin curves (hazard ratio, 0.83; 95% CI, 0.70 to 0.99), but this benefit did not continue after equalization of the glycated hemoglobin levels (hazard ratio, 1.26; 95% CI, 0.90 to 1.75).

CONCLUSIONS

Participants with type 2 diabetes who had been randomly assigned to intensive glucose control for 5.6 years had a lower risk of cardiovascular events than those who received standard therapy only during the prolonged period in which the glycated hemoglobin curves were separated. There was no evidence of a legacy effect or a mortality benefit with intensive glucose control. (Funded by the VA Cooperative Studies Program; VADT ClinicalTrials.gov number, NCT00032487.)

Author/s:

Emanuele, N.V., Reaven, P.D., Wiitala, W.L., Bahn, G.D., Reda D.J., McCarren, M., Duckworth, W.C., Hayward, R.A., VADT Investigators

Prediction of individual life-years gained without cardiovascular events from lipid, blood pressure, glucose, and aspirin treatment based on data of more than 500 000 patients with Type 2 diabetes mellitus

Jeffrey Wilson — Sun, 03 Feb 2019 21:22:07 +0000

Date Added:

February 3, 2019

Journal/Publication:

European Heart Journal

Publisher:

Oxford University Press

Publication Date:

January 9, 2019

URL:

Prediction of individual life-years gained without cardiovascular events from lipid, blood pressure, glucose, and aspirin treatment based on data of more than 500 000 patients with Type 2 diabetes mellitus.

Type:

Clinical Decision Aids

DOI (1):

10.1093/eurheartj/ehy839

Keywords

cardiovascular disease

cardiovascular events

PMID (1):

30629157

MeSH

glycated hemoglobin, A

lipoprotein cholesterol

diabetes mellitus, type 2

blood pressure

insulin

glucose

cardiovascular diseases

RPR Commentary: The authors have developed and validated several calculators that predict lifetime risk of CV events based upon age, gender, smoking, blood pressure, lipids, A1c, and use of antiplatelet agents. They can be accessed at www.U-Prevent.com.

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AIMS:

Although group-level effectiveness of lipid, blood pressure, glucose, and aspirin treatment for prevention of cardiovascular disease (CVD) has been proven by trials, important differences in absolute effectiveness exist between individuals. We aim to develop and validate a prediction tool for individualizing lifelong CVD prevention in people with Type 2 diabetes mellitus (T2DM) predicting life-years gained without myocardial infarction or stroke.

METHODS AND RESULTS:

We developed and validated the Diabetes Lifetime-perspective prediction (DIAL) model, consisting of two complementary competing risk adjusted Cox proportional hazards functions using data from people with T2DM registered in the Swedish National Diabetes Registry (n = 389 366). Competing outcomes were (i) CVD events (vascular mortality, myocardial infarction, or stroke) and (ii) non-vascular mortality. Predictors were age, sex, smoking, systolic blood pressure, body mass index, haemoglobin A1c, estimated glomerular filtration rate, non- high-density lipoprotein cholesterol, albuminuria, T2DM duration, insulin treatment, and history of CVD. External validation was performed using data from the ADVANCE, ACCORD, ASCOT and ALLHAT-LLT-trials, the SMART and EPIC-NL cohorts, and the Scottish diabetes register (total n = 197 785). Predicted and observed CVD-free survival showed good agreement in all validation sets. C-statistics for prediction of CVD were 0.83 (95% confidence interval: 0.83-0.84) and 0.64-0.65 for internal and external validation, respectively. We provide an interactive calculator at www.U-Prevent.com that combines model predictions with relative treatment effects from trials to predict individual benefit from preventive treatment.

CONCLUSION:

Cardiovascular disease-free life expectancy and effects of lifelong prevention in terms of CVD-free life-years gained can be estimated for people with T2DM using readily available clinical characteristics. Predictions of individual-level treatment effects facilitate translation of trial results to individual patients.

Author/s:

Berkelmans, Gijs F N, Gudbjörnsdottir, Soffia, Visseren, Frank L J, Wild, Sarah H, Franzen, Stefan, Chalmers, John, Davis, Barry R, Poulter, Neil R, Spijkerman, Annemieke M, Woodward, Mark, Pressel, Sara L, Gupta, Ajay K, van der Schouw, Yvonne T, Svensson, Ann-Marie