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Association between 7 years of intensive treatment of type 1 diabetes and long-term mortality.

ABSTRACT: Whether mortality in type 1 diabetes mellitus is affected following intensive glycemic therapy has not been established.To determine whether mortality differed between the original intensive and conventional treatment groups in the long-term follow-up of the Diabetes Control and Complications Trial (DCCT) cohort.After the DCCT (1983-1993) ended, participants were followed up in a multisite (27 US and Canadian academic clinical centers) observational study (Epidemiology of Diabetes Control and Complications [EDIC]) until December 31, 2012. Participants were 1441 healthy volunteers with diabetes mellitus who, at baseline, were 13 to 39 years of age with 1 to 15 years of diabetes duration and no or early microvascular complications, and without hypertension, preexisting cardiovascular disease, or other potentially life-threatening disease.During the clinical trial, participants were randomly assigned to receive intensive therapy (n?=?711) aimed at achieving glycemia as close to the nondiabetic range as safely possible, or conventional therapy (n?=?730) with the goal of avoiding symptomatic hypoglycemia and hyperglycemia. At the end of the DCCT, after a mean of 6.5 years, intensive therapy was taught and recommended to all participants and diabetes care was returned to personal physicians.Total and cause-specific mortality was assessed through annual contact with family and friends and through records over 27 years' mean follow-up.Vital status was ascertained for 1429 (99.2%) participants. There were 107 deaths, 64 in the conventional and 43 in the intensive group. The absolute risk difference was -109 per 100,000 patient-years (95% CI, -218 to -1), with lower all-cause mortality risk in the intensive therapy group (hazard ratio [HR]?=?0.67 [95% CI, 0.46-0.99]; P?=?.045). Primary causes of death were cardiovascular disease (24 deaths; 22.4%), cancer (21 deaths; 19.6%), acute diabetes complications (19 deaths; 17.8%), and accidents or suicide (18 deaths; 16.8%). Higher levels of glycated hemoglobin (HbA1c) were associated with all-cause mortality (HR?=?1.56 [95% CI, 1.35-1.81 per 10% relative increase in HbA1c]; P?

SUBMITTER: Writing Group for the DCCT/EDIC Research Group

PROVIDER: S-EPMC4306335 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Association between 7 years of intensive treatment of type 1 diabetes and long-term mortality.

Orchard Trevor J TJ Nathan David M DM Zinman Bernard B Cleary Patricia P Brillon David D Backlund Jye-Yu C JY Lachin John M JM

JAMA 20150101 1

<h4>Importance</h4>Whether mortality in type 1 diabetes mellitus is affected following intensive glycemic therapy has not been established.<h4>Objective</h4>To determine whether mortality differed between the original intensive and conventional treatment groups in the long-term follow-up of the Diabetes Control and Complications Trial (DCCT) cohort.<h4>Design, setting, and participants</h4>After the DCCT (1983-1993) ended, participants were followed up in a multisite (27 US and Canadian academic ...[more]

PMID: 25562265

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Project description:BackgroundIntensive diabetes treatment reduces the risk of developing albuminuria in individuals with type 1 diabetes. Effects on the long-term clinical course of kidney disease remain to be defined. We aimed to compare the long-term effects of intensive versus conventional treatment on incident albuminuria.MethodsFor this long-term follow-up study of the Diabetes Control and Complications Trial (DCCT) we assessed the effect of intensive diabetes treatment on albuminuria during 18 years after the completion of the trial. During the DCCT (1983-1993), 1441 participants with type 1 diabetes were randomly assigned to receive either intensive treatment (with the goal of achieving levels of glycaemia as close to the non-diabetic range as safely possible) or conventional treatment (aimed at prevention of symptoms of hyperglycaemia and hypoglycaemia). At the end of the DCCT, all participants were instructed in intensive treatment, and all participants were invited to join the observational Epidemiology of Diabetes Interventions and Complications (EDIC) study. Mean HbA1c during the EDIC study was similar in the two groups of patients who differed in their treatment assignment during the DCCT. Albumin excretion rate was measured every other year during the EDIC study. Microalbuminuria was defined as an albumin excretion rate of 30 mg per 24 h or higher on two consecutive study visits and macroalbuminuria as an albumin excretion rate of 300 mg per day or higher. We estimated glomerular filtration rate from annual serum creatinine measurements throughout DCCT and the EDIC study. The DCCT is registered with ClinicalTrials.gov, number NCT00360815, and the EDIC study, with number NCT00360893.FindingsDuring years 1-18 of EDIC, we noted 191 new cases of microalbuminuria (71 in the group receiving intensive treatment during DCCT and 120 in the group receiving conventional treatment during DCCT; risk reduction 45%, 95% CI 26-59) and 117 new cases of macroalbuminuria (31 intensive, 86 conventional; 61%, 41-74). At year 17-18 of EDIC, the prevalence of albumin excretion rate of 30 mg per 24 h or higher was 18·4% in participants assigned to intensive treatment during the DCCT, compared with 24·9% in participants assigned to conventional treatment (p=0·02). During years 1-18 of EDIC, we recorded 84 cases of sustained estimated glomerular filtration rate lower than 60 mL/min per 1·73m(2) (31 intensive, 53 conventional; risk reduction 44%, 95% CI 12-64).InterpretationIn individuals with type 1 diabetes, intensive diabetes treatment yields durable renal benefits that persist for at least 18 years after its application. Ultimately, such benefits should result in fewer patients requiring renal replacement therapy.FundingNational Institute of Diabetes and Digestive and Kidney Disease.

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Association between 7 years of intensive treatment of type 1 diabetes and long-term mortality.

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Association between 7 years of intensive treatment of type 1 diabetes and long-term mortality.

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