Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial
Open accessAbstract
Design ACCORD is a parallel group, randomized trial designed to investigate whether intensive glycemic therapy with a target HbA1c of <6.0% versus standard therapy with a target of 7.0 to 7.9% reduces cardiovascular disease (CVD) morbidity, mortality, and microvascular complications in participants with type 2 diabetes. Methods Volunteers with established type 2 diabetes, HbA1c levels ≥ 7.5% and CVD or two or more CVD risk factors were recruited at 77 clinical sites across the U.S. and Canada. Instructional materials, behavioral counseling, glucose-lowering medications and self-monitoring supplies were provided by the study. Therapeutic regimens were individualized on the basis of randomized assignment and response to therapy. This investigation examines the effect of treatment to glycemic goals on occurrence of microvascular diabetes complications. Prespecified composite outcomes were: 1) dialysis or renal transplantation, or serum creatinine >291.7 micromol/L, or retinal photocoagulation or vitrectomy, and 2) these plus peripheral neuropathy. Thirteen prespecified secondary measures of kidney, eye, and peripheral nerve function were also evaluated. Randomization was performed at clinical sites using a central randomization routine available on the study website. Both investigators and participants were unmasked to treatment arm assignment. Results A total of 10,251 participants were randomized (5,128 intensive and 5,123 standard) between January, 2001 and October, 2005. This analysis includes 10,234 patients (5,107 intensive and 5,108 standard). Intensive therapy was stopped before study end due to increased mortality, and patients were transitioned to standard therapy. Outcomes are reported at transition and at study end. At transition, the first composite outcome occurred in 443/5107 and 444/5108 participants in the intensive and standard arms, respectively (p= 0.99), and the second outcome in 1591/5107 and 1659/5108 participants in intensive and standard arms (p=0.20). Results were similar at study end. Secondary measures at study end favoring intensive therapy (p<0.05) included development of macroalbuminuria, cataract extraction, visual acuity, a score of >2.0 on the Michigan Neuropathy Screening Instrument, loss of ankle jerk and light touch. Conclusions Intensive glycemic treatment did not reduce the risk of advanced measures of microvascular outcomes, but delayed the onset of macroalbuminuria and some measures of eye complications and neuropathy. These benefits must be weighed against the increase in total and CVD-related mortality, increased weight gain, and higher risk for severe hypoglycemia.
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Numerous studies have demonstrated the clinical benefits of early achievement of near-normal glycemic control in individuals with type 1 diabetes and type 2 diabetes.
“Numerous studies have demonstrated the clinical benefits of early achievement of nearnormal glycemic control in individuals with type 1 diabetes and type 2 diabetes (77-83).”
From Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range (2019) · cites this paper as [82]
The Introduction (page not provided) reports that several trials found reduced microvascular complications with intensive glycemic control in type 2 diabetes. The Discussion notes benefits in a trial that began at diagnosis, but ACCORD itself studied people with long-standing type 2 diabetes. This source does not establish the claimed benefits for type 1 diabetes or directly demonstrate benefits from early achievement of near-normal control. (LLM, conf=0.87)
Experimental — accuracy not yet measuredIntensive lowering of blood glucose with the goal of achieving near-normoglycemia has been shown in large randomized studies to delay the onset and progression of albuminuria and reduce eGFR in people with type 1 diabetes and type 2 diabetes.
“Intensive lowering of blood glucose with the goal of achieving near-normoglycemia has been shown in large, randomized studies to delay the onset and progression of albuminuria and reduce eGFR in people with type 1 diabetes (52,53) and type 2 diabetes (1,(54)(55)(56)(57)(58)(59).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [56]
For the type 2 diabetes portion attributed to this source, the Results report less new macroalbuminuria with intensive treatment and a short-term decline in eGFR; the microalbuminuria difference was no longer significant at study end. The paper does not establish delayed progression of existing albuminuria, and the eGFR difference was not significant at study end. The type 1 diabetes portion has separate citations and is not assessed here. (LLM, conf=0.86)
Experimental — accuracy not yet measuredLowering blood glucose itself helps prevent CKD and its progression.
“Insulin alone was used to lower blood glucose in the Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) study of type 1 diabetes, while a variety of agents were used in clinical trials of type 2 diabetes, supporting the conclusion that lowering blood glucose itself helps prevent CKD and its progression.”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [56]
The Results (page not provided) show that intensive glucose-lowering treatment reduced new macroalbuminuria, a renal risk marker. They also report no significant reduction in overt renal failure and a temporary renal outcome favoring standard treatment. The paper therefore supports a narrower renal benefit, not the unqualified conclusion that lowering glucose itself prevents CKD and its progression. (LLM, conf=0.87)
Experimental — accuracy not yet measuredThe ADVANCE and VADT trials found modest reduction in nephropathy with intensive glycemic management; ACCORD was stopped after a median of 3.5 years due to higher mortality in the intervention arm.
“The ADVANCE and VADT trials found modest reduction in nephropathy with intensive glycemic management; ACCORD was stopped after a median of 3.5 years due to higher mortality in the intervention arm (51-55).”
From 6. Glycemic Goals, Hypoglycemia, and Hyperglycemic Crises: Standards of Care in Diabetes-2026. (2026) · cites this paper as [53]
The Discussion reports that ADVANCE and VADT found reductions in microalbuminuria with intensive glycemic treatment, supporting the renal-outcome point at that narrower level. The Introduction says ACCORD’s intensive strategy was stopped because of increased all-cause mortality, but gives a median follow-up of 3.7 years, not 3.5 years. Page numbers are unavailable in our copy. (LLM, conf=0.90)
Experimental — accuracy not yet measuredThe ACCORD trial, with 35% of participants having a previous cardiovascular event, showed increased mortality (HR 1.22; 95% CI, 1.01-1.46; P = 0.04) in the intensive glycaemic arm (HbA1c 6.5%, 48 mmol/mol) compared with controls.
“Of interest, the ACCORD trial, with 35% of participants having a previous CV event, showed increased mortality (HR 1.22; 95% CI, 1.01-1.46;P = 0.04) in the intensive glycaemic arm (HbA1c 6.5%, 48 mmol/mol) compared with controls.129”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [129]
Studies testing lifestyle and drug interventions to delay diabetes onset have generally shown benefit, with lifestyle outperforming all medications except thiazolidinediones.
“These trials have more or less uniformly demonstrated a benefit, with lifestyle more efficacious than all medications with the exception of the thiazolidinediones140–152.”
From Pathophysiology and treatment of type 2 diabetes: perspectives on the past, present, and future (2014) · cites this paper as [149]
Only reports of troglitazone in the DPP and glargine in ORIGIN suggest a residual benefit after prolonged withdrawal of the intervention.
“Only reports of the effects of troglitazone in the DPP149 and glargine in ORIGIN123 suggest a residual benefit after prolonged withdrawal of the intervention.”
From Pathophysiology and treatment of type 2 diabetes: perspectives on the past, present, and future (2014) · cites this paper as [149]
The Michigan Neuropathy Screening Instrument questionnaire has been validated to assess distal diabetic peripheral neuropathy compared with gold standard diagnostic testing and has been widely used in large clinical trials.
“The MNSI questionnaire has been validated to assess distal DPN compared with gold standard diagnostic testing and has been widely used in large clinical trials, including Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC), Action to Control Cardiovascular Risk in Diabetes (ACCORD) and Bypass Angioplasty Revascularization Investigation 2”
From Glucose time in range and peripheral neuropathy in type 2 diabetes mellitus and chronic kidney disease (2020) · cites this paper as [15]
Michigan Neuropathy Screening Instrument questionnaire score ≥2 was the primary outcome definition for diabetic peripheral neuropathy because it was also used in the ACCORD and BARI-2D studies.
“MNSI questionnaire score ≥2 was our primary outcome definition for DPN because it was also used in the ACCORD and BARI-2D studies.14 15”
From Glucose time in range and peripheral neuropathy in type 2 diabetes mellitus and chronic kidney disease (2020) · cites this paper as [15]
Improved glycemic control dramatically reduces the risk of diabetic peripheral neuropathy in people with type 1 diabetes mellitus but only modestly reduces the incidence of diabetic peripheral neuropathy in type 2 diabetes mellitus.
“Improved glycemic control has been shown to dramatically reduce the risk of DPN in people with type 1 DM but only modestly reduce the incidence of DPN in type 2 DM.13–15”
From Glucose time in range and peripheral neuropathy in type 2 diabetes mellitus and chronic kidney disease (2020) · cites this paper as [15]
In the ACCORD trial, the intensive glycemic therapy arm was associated with a lower prevalence of Michigan Neuropathy Screening Instrument score ≥2 at the end of the study (HR 0.92, 95% CI 0.86 to 0.99).
“For example, in the ACCORD trial, intensive glycemic therapy arm was associated with a lower prevalence of MNSI score ≥2 at the end of the study (HR 0.92 (95% CI 0.86 to 0.99)).15”
From Glucose time in range and peripheral neuropathy in type 2 diabetes mellitus and chronic kidney disease (2020) · cites this paper as [15]
In type 2 diabetes mellitus, enhanced glycemic control has been demonstrated to more modestly reduce the risk of developing diabetic peripheral neuropathy by 5%-9%.
“In type 2 DM, enhanced glycemic control has been demonstrated to more modestly reduce the risk of developing, by DPN 5%–9%.14 15 32”
From Glucose time in range and peripheral neuropathy in type 2 diabetes mellitus and chronic kidney disease (2020) · cites this paper as [15]
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11. Chronic Kidney Disease and Risk Management: <i>Standards of Medical Care in Diabetes—2022</i>
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11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025
American Diabetes Association Professional Practice Committee, ElSayed, N. A., McCoy, R. G., Aleppo, G., Balapattabi, K., Beverly, E. A., Briggs Early, K., Bruemmer, D., Echouffo-Tcheugui, J. B., Ekhlaspour, L., et al. (2025) · Diabetes Care · doi:10.2337/dc25-s011 · Cited by 262 · see citing works
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Self-citationLong-term benefits of intensive glucose control for preventing end-stage kidney disease: ADVANCE-ON
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12. Retinopathy, Neuropathy, and Foot Care: <i>Standards of Medical Care in Diabetes—2022</i>
American Diabetes Association Professional Practice Committee (2022) · Diabetes Care · doi:10.2337/dc22-s012 · Cited by 177 · see citing works
12. Retinopathy, Neuropathy, and Foot Care: <i>Standards of Care in Diabetes—2023</i>
ElSayed, N. A., Aleppo, G., Aroda, V. R., Bannuru, R. R., Brown, F. M., Bruemmer, D., Collins, B. S., Gibbons, C. H., Giurini, J. M., Hilliard, M. E., et al. (2023) · Diabetes Care · doi:10.2337/dc23-s012 · Cited by 169 · see citing works
12. Retinopathy, Neuropathy, and Foot Care: Standards of Care in Diabetes—2025
American Diabetes Association Professional Practice Committee, ElSayed, N. A., McCoy, R. G., Aleppo, G., Balapattabi, K., Beverly, E. A., Briggs Early, K., Bruemmer, D., Callaghan, B. C., Echouffo-Tcheugui, J. B., et al. (2025) · Diabetes Care · doi:10.2337/dc25-s012 · Cited by 176 · see citing works
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Intensive treatment and severe hypoglycemia among adults with type 2 diabetes
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Self-citationDhatariya, K., Bain, S. C., Buse, J. B., Simpson, R., Tarnow, L., Kaltoft, M. S., Stellfeld, M., Tornøe, K., Pratley, R. E., & the LEADER Publication Committee on behalf of the LEADER Trial Investigators (2018) · Diabetes Care · doi:10.2337/dc18-1094 · Cited by 141 · see citing works
6. Glycemic Goals, Hypoglycemia, and Hyperglycemic Crises: Standards of Care in Diabetes-2026.
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Diabetic Sensory and Motor Neuropathy
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Real-world assessments of mySugr mobile health app
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Cost-effectiveness of an electronic medical record based clinical decision support system
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Self-citationGLP-1 agonist to treat obesity and prevent cardiovascular disease: what have we achieved so far
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Glycated hemoglobin and outcomes in patients with advanced diabetic chronic kidney disease
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“Serum creatinine was measured every 4 months and albuminuria was assessed yearly.(18) Microalbuminuria and macroalbuminuria were defined as urinary albumin-to-creatinine ratio $ 30 mg/g and $ 300 mg/g in a random urine sample, respectively.”
MethodSelf-citationRapamycin-Induced Glucose Intolerance: Hunger or Starvation Diabetes
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Update on the Management of Diabetic Neuropathy
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Economic burden of hypoglycemia in patients with type 2 diabetes
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“or prevent microvascular and macrovascular diabetes complications (8,10,38).”
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- Authors
- Ismail-Beigi, F., Craven, T., Banerji, M. A., Basile, J., Calles, J., Cohen, R. M., Cuddihy, R., Cushman, W. C., Genuth, S., Grimm, R. H., Hamilton, B. P., Hoogwerf, B., Karl, D., Katz, L., Krikorian, A., O'Connor, P., Pop-Busui, R., Schubart, U., Simmons, D., Taylor, H., Thomas, A., Weiss, D., & Hramiak, I.
- Affiliations
- Wake Forest University Health Sciences (US)
- SUNY Downstate Health Sciences University (US)
- Medical University of South Carolina (US)
- Atrium Health Wake Forest Baptist (US)
- Cincinnati VA Medical Center (US)
- University of Minnesota (US)
- Memphis VA Medical Center (US)
- Case Western Reserve University (US)
- Berman Center for Outcomes and Clinical Research (US)
- University of Maryland, Baltimore (US)
- Eli Lilly (United States) (US)
- Oregon Health & Science University (US)
- VA NY Harbor Healthcare System (US)
- Albert Einstein College of Medicine (US)
- University of Arkansas for Medical Sciences (US)
- Henry Ford Hospital (US)
- St Joseph's Health Care (CA)
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2010-08
- Volume
- 376
- Issue
- 9739
- Pages
- 419-430
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC4123233
- OpenAlex
- W2111824270
- Semantic Scholar
- 9f567e2ec7817ac706243a05def9b19b0e7bf26c
- Cited by
- 1,428
- References
- 41
- Citations by year
- 2026: 36 · 2025: 50 · 2024: 77 · 2023: 76 · 2022: 107 · 2021: 101 · 2020: 103 · 2019: 99 · 2018: 122 · 2017: 91 · 2016: 82 · 2015: 90 · 2014: 111 · 2013: 84 · 2012: 87
- FWCI
- 68.26
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (n01hc95183-23-0-0, n01hc95180-24-0-1, n01hc95184-24-0-1, n01hc95181-23-0-1, n01hc95182-23-0-1, n01hc95178-28-0-1, n01hc95179-25-0-0)
- National Heart, Lung, and Blood Institute (N01- HC-95181, R01HL073030, N01 HC095184, N01-HC- 95180, N01-HC-95178, N01 HC095182, N01 HC095181, Y01 HC001010, N01-HC-095183, N01 HC095178, N01-HC-95184, N01HC95179, IAAY1-HC-1010, IAA #Y1-HC-9035, N01 HC095180, N01‐HC‐95183, N01-HC-95182, N01 HC095179)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- type 2 diabetes, tight glycemic control, hyperglycemia, microvascular complications, HbA1c, renal outcomes, retinopathy, diabetic nephropathy, diabetic retinopathy, diabetic neuropathy, ACCORD trial, cardiovascular disease, cardiovascular complications, renal function, eye function, nerve function, serum creatinine, retinal photocoagulation, vitrectomy
- MeSH terms
- Adult, Aged, Blood Glucose, Diabetes Mellitus, Type 2, Diabetic Angiopathies, Diabetic Nephropathies, Diabetic Neuropathies, Diabetic Retinopathy, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Lipids, Middle Aged
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