DIABETES CARE, VOLUME 23, NUMBER 10, OCTOBER 2000 1455 C igarette smoking is the leading pre- ventable cause of illness and prema- ture death in developed countries (1). Evidence that cigarette consumption has a synergic effect with diabetes and increases the morbidity and mortality of type 1 and 2 diabetic patients is accumu- lating (2–6). However, smoking preva- lence among diabetic patients has been estimated to be almost the same as in the general population (4,7). Among the general population, sev- eral studies have shown that physician counseling during a simple routine con- sultation increases the likelihood that the patient will stop smoking (8,9). The effec- tiveness of nurse-led interventions is not as clear (8). Two randomized studies assessing the effectiveness of health checks by nurses in the reduction of cardiovascu- lar risk factors (10,11) called into question the programs’ efficacy in terms of smoking cessation. However, interventions directed toward selected subgroups of smokers who are at special risk (e.g., pregnant women and patients with coronary heart disease [CHD]) appear to be particularly effective (8,12). Few studies have evaluated the effec- tiveness of interventions with diabetic smokers using a randomized design, and those studies did not have very optimistic results (2,4,5). Moreover, the limited num- ber of studies on smoking cessation in dia- betes, which generally have not used a randomized design and are based on small sample sizes, supports the proposal that more research on intervention programs tailored to diabetic smokers is needed (2). Our purpose was to evaluate the effec- tiveness of a nurse-led face-to-face individ- ually structured intervention aimed at helping diabetic smokers quit smoking. RESEARCH DESIGN AND M ETH O D S Study population This study took place in an urban capital city and its metropolitan area of 232,497 inhabitants (Pamplona, which is the capital of Navarre, Spain). Participation included the 2 hospitals that care for diabetic patients (the University Clinic of Navarre and the Hospital of Navarre) and 15 existing urban primary care centers. All (type 1 or type 2) diabetic patients who were registered either in these primary care centers or in the 2 hospitals during the intervention period were included in the study. Research design Subjects were randomly assigned to exper- imental or control groups using a com- puter-generated allocation method. The randomized assignment was blinded. Once a patient was considered eligible for the study, the nurse carrying out the interven- tion opened a sealed envelope that deter- From the Department of Nursing Studies (N.C., M.J.D., A.F .), School of Nursing and the Department of Epi- demiology and Public Health (J.D.I., E.V., M.A.M.-G.), School of Medicine, University of Navarre, Pamplona, Spain. Address correspondence and reprint requests to Miguel A. Martínez-González, MD, PhD, MPH, Depar- tamento de Epidemiología y Salud Pública, Facultad de Medicina, Universidad de Navarre, Irunlarrea s/n, 31080, Pamplona, Spain. E-mail: mamartinez@ unav.es. Received for publication 17 April 2000 and accepted in revised form 6 June 2000. Abbreviations: CHD, coronary heart disease; FTND, Fagerström Test for Nicotine Dependence; NRT, nicotine replacement therapy. A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances. Intervention Study for Smoking Cessation in Diabetic Patients A randomized controlled trial in both clinical and primary care settings O R I G I N A L A R T I C L E O BJECTI V E — To evaluate the effectiveness of a nurse-managed smoking cessation inter- vention in diabetic patients. RESEARCH DESIGN AND M ETHODS — This randomized controlled clinical trial involved 280 diabetic smokers (age range 17–84 years) who were randomized either into con- trol ( n = 133) or intervention ( n = 147) groups at 12 primary care centers and 2 hospitals located in Navarre, Spain. The intervention consisted of a 40-min nurse visit that included counseling, education, and contracting information (a negotiated cessation date). The follow- up consisted of telephone calls, letters, and visits. The control group received the usual care for diabetic smokers. Baseline and 6-month follow-up measurements included smoking status (self-reported cessation was verified by urine cotinine concentrations), mean number of ciga- rettes smoked per day, and stage of change. RESU LTS — At the 6-month follow-up, the smoking cessation incidence was 17.0% in the intervention group compared with 2.3% in the usual care group, which was a 14.7% difference (95% CI 8.2–21.3%). Among participants who continued smoking, a significant reduction was evident in the average cigarette consumption at the 6-month follow-up. The mean number of cigarettes per day decreased from 20.0 at baseline to 15.5 at 6 months for the experimental group versus from 19.7 to 18.1 for the control group ( P  0.01). CO N CLU SI O N S — A structured intervention managed by a single nurse was shown to be effective in changing the smoking behavior of diabetic patients. Diabetes Care 23:1455–1460, 2000 NAVIDAD CANGA, BSC J OKIN DE IRALA, MD, PHD, MPH EDUARDO V ARA, MD MARÍA J. DUASO, MA ASUNCIÓN FERRER, MSC MIGUEL A. MARTÍNEZ-GONZÁLEZ, MD, PHD, MPH Clinical Care/Education/Nutrition