Multimorbidity and mortality: A 15-year longitudinal registry-based nationwide Danish population study.

BACKGROUND: Knowledge about prevalent and deadly combinations of multimorbidity is needed. OBJECTIVE: To determine the nationwide prevalence of multimorbidity and estimate mortality for the most prevalent combinations of one to five diagnosis groups. Furthermore, to assess the excess mortality of the combination of two groups compared to the product of mortality associated with the single groups. DESIGN: A prospective cohort study using Danish registries and including 3.986.209 people aged ≥18 years on 1 January, 2000. Multimorbidity was defined as having diagnoses from at least 2 of 10 diagnosis groups: lung, musculoskeletal, endocrine, mental, cancer, neurological, gastrointestinal, cardiovascular, kidney, and sensory organs. Logistic regression (odds ratios, ORs) and ratio of ORs (ROR) were used to study mortality and excess mortality. RESULTS: Prevalence of multimorbidity was 7.1% in the Danish population. The most prevalent combination was the musculoskeletal-cardiovascular (0.4%), which had double the mortality (OR, 2.03) compared to persons not belonging to any of the diagnosis groups but showed no excess mortality (ROR, 0.97). The neurological-cancer combination had the highest mortality (OR, 6.35), was less prevalent (0.07%), and had no excess mortality (ROR, 0.94). Cardiovascular-lung was moderately prevalent (0.2%), had high mortality (OR, 5.75), and had excess mortality (ROR, 1.18). Endocrine-kidney had high excess mortality (ROR, 1.81) and cancer-mental had low excess mortality (ROR, 0.66). Mortality increased with the number of groups. CONCLUSIONS: All combinations had increased mortality risk with some of them having up to a six-fold increased risk. Mortality increased with the number of diagnosis groups. Most combinations did not increase mortality above that expected, that is, were additive rather than synergistic.

Interpretation of HbA1c in primary care and potential influence of anaemia and chronic kidney disease: an analysis from the Copenhagen Primary Care Laboratory (CopLab) Database.

AIMS: To investigate, in a large population in primary care, the relationship between fasting plasma glucose and HbA1c measurements, as well as the clinical implications of anaemia or chronic kidney disease for the interpretation of HbA1c values. METHODS: From a primary care resource, we examined HbA1c and fasting plasma glucose as well as haemoglobin and estimated GFR. We stratified observations by chronic kidney disease stage and anaemia level. The estimation of the mean fasting plasma glucose level from HbA1c alone, and from HbA1c , haemoglobin and estimated GFR, respectively, was evaluated. RESULTS: In 198 346 individuals, the fasting plasma glucose-HbA1c relationship mimicked the regression described in the A1c-Derived Average Glucose (ADAG) study, which was based on average capillary and interstitial glucose. The fasting plasma glucose-HbA1c relationship was unaffected in mild to moderate chronic kidney disease and in mild to moderate anaemia. The correlation changed only in severe hyperglycaemia and concurrent severe anaemia or when estimated GFR was <45 ml/min/1.73m², so that glucose concentration was underestimated by HbA1c in anaemia and overestimated in chronic kidney disease. The prevalence of estimated GFR <30 ml/min/1.73m² was 0.82%, while the prevalence of haemoglobin <81 g/l (5.0 mmol/l) was 0.11%. CONCLUSIONS: The relationship between fasting plasma glucose and HbA1c mimics that of the people with diabetes included in the ADAG study. Mild to moderate anaemia and CKD do not have a significant impact on the interpretation of HbA1c as a marker of retrograde glycaemia. Hence, it seems justified to use HbA1c without adjustment in primary care.

Motivation, effort and life circumstances as predictors of foot ulcers and amputations in people with Type 2 diabetes mellitus.

AIM: To investigate the predictive value of both patients' motivation and effort in their management of Type 2 diabetes and their life circumstances for the development of foot ulcers and amputations. METHODS: This study was based on the Diabetes Care in General Practice study and Danish population and health registers. The associations between patient motivation, effort and life circumstances and foot ulcer prevalence 6 years after diabetes diagnosis and the incidence of amputation in the following 13 years were analysed using odds ratios from logistic regression and hazard ratios from Cox regression models, respectively. RESULTS: Foot ulcer prevalence 6 years after diabetes diagnosis was 2.93% (95% CI 1.86-4.00) among 956 patients. General practitioners' indication of 'poor' vs 'very good' patient motivation for diabetes management was associated with higher foot ulcer prevalence (odds ratio 6.11, 95% CI 1.22-30.61). The same trend was seen for 'poor' vs 'good' influence of the patient's own effort in diabetes treatment (odds ratio 7.06, 95% CI 2.65-18.84). Of 1058 patients examined at 6-year follow-up, 45 experienced amputation during the following 13 years. 'Poor' vs 'good' influence of the patients' own effort was associated with amputation (hazard ratio 7.12, 95% CI 3.40-14.92). When general practitioners assessed the influence of patients' life circumstances as 'poor' vs 'good', the amputation incidence increased (hazard ratio 2.97, 95% CI 1.22-7.24). 'Poor' vs 'very good' patient motivation was also associated with a higher amputation incidence (hazard ratio 7.57, 95% CI 2.43-23.57), although not in fully adjusted models. CONCLUSIONS: General practitioners' existing knowledge of patients' life circumstances, motivation and effort in diabetes management should be included in treatment strategies to prevent foot complications.

Structured personal care of type 2 diabetes: a 19 year follow-up of the study Diabetes Care in General Practice (DCGP).

AIMS/HYPOTHESIS: This study is a 19 year observational follow-up of a pragmatic open multicentre cluster-randomised controlled trial of 6 years of structured personal diabetes care starting from diagnosis. METHODS: A total of 1,381 patients aged ≥ 40 years and newly diagnosed with type 2 diabetes were followed up in national registries for 19 years. Clinical follow-up was at 6 and 14 years after diabetes diagnosis. The original 6 year intervention included regular follow-up and individualised goal setting, supported by prompting of doctors, clinical guidelines, feedback and continuing medical education (ClinicalTrials.gov NCT01074762). The registry-based endpoints were: incidence of any diabetes-related endpoint; diabetes-related death; all-cause mortality; myocardial infarction (MI); stroke; peripheral vascular disease; and microvascular disease. RESULTS: At 14 year clinical follow-up, group differences in risk factors from the 6 year follow-up had levelled out, although the prevalence of (micro)albuminuria and level of triacylglycerols were lower in the intervention group. During 19 years of registry-based monitoring, all-cause mortality was not different between the intervention and comparison groups (58.9 vs 62.3 events per 1,000 patient-years, respectively; for structured personal care, HR 0.94, 95% CI 0.83, 1.08, p = 0.40), but a lower risk emerged for fatal and non-fatal MI (27.3 vs 33.5, HR 0.81, 95% CI 0.68, 0.98, p = 0.030) and any diabetes-related endpoint (69.5 vs 82.1, HR 0.83, 95% CI 0.72, 0.97, p = 0.016). These differences persisted after extensive multivariable adjustment. CONCLUSIONS/INTERPRETATION: In concert with features such as prompting, feedback, clinical guidelines and continuing medical education, individualisation of goal setting and drug treatment may safely be applied to treat patients newly diagnosed with type 2 diabetes to lower the risk of diabetes complications.

Amputations and foot ulcers in patients newly diagnosed with type 2 diabetes mellitus and observed for 19 years. The role of age, gender and co-morbidity.

AIMS: To determine the prevalence of foot ulcers and the incidence of amputations in patients with Type 2 diabetes observed for 19 years after diagnosis. We investigated the role of gender, age and co-morbidities. METHODS: From the Diabetes Care in General Practice study, 1381 patients were included and examined at diabetes diagnosis, at 6 years and at 14 years after diagnosis. Register-based follow-up was for 19 years. Foot ulcers and amputations were related to gender, age and co-morbidities by odds and hazard ratios from logistic and Cox regression models, respectively. RESULTS: The incidence of any amputation and major amputation was 400 (95% CI 307-512) and 279 (95% CI 203-375) per 100,000 patient-years, respectively. At the three observation points, the foot ulcer prevalences were 2.76% (95% CI 1.89-3.63), 2.93% (95% CI 1.86-4.00) and 4.96% (95% CI 3.10-6.82). Multivariate analyses showed associations between foot ulcers and peripheral neuropathy, peripheral arterial disease, male gender, retinopathy and myocardial infarction. After multivariate adjustment, significant predictors (hazard ratio; 95% CI) of any amputation were peripheral neuropathy (hazard ratio 2.09; 95% CI 1.19-3.69), peripheral arterial disease (hazard ratio 3.43; 95% CI 1.65-7.12), microalbuminuria (hazard ratio 2.11; 95% CI 1.21-3.67), retinopathy (hazard ratio 6.42; 95% CI 2.59-15.90), impaired vision (hazard ratio 6.92; 95% CI 2.35-20.38) and male gender (hazard ratio 2.40; 95% CI 1.31-4.41). For women, the risk of amputation increased with age, but for men the risk was higher when diagnosed with diabetes at a younger age. CONCLUSIONS: Despite improved treatment regimens, the incidence of amputations is still high in this population-based patient sample. Men diagnosed with diabetes before age 65 years and patients with diabetes-related co-morbidities are at particularly high risk of foot ulcers and amputations.

Patients newly diagnosed with clinical type 2 diabetes mellitus but presenting with HbA1c within normal range: 19-year mortality and clinical outcomes.

AIMS: To investigate whether long-term mortality or clinical outcomes differed between patients diagnosed with type 2 diabetes mellitus and presenting with HbA1c within or above normal range at time of diagnosis. METHODS: Data were from a population-based sample of 1136 individuals with newly diagnosed type 2 diabetes mellitus. The diagnosis was confirmed with a single fasting whole blood/plasma glucose ≥7.0/8.0mmol/l. The median time from day of diagnosis until end of follow up was 18.8years. Patients were grouped according to normal HbA1c and elevated HbA1c at diagnosis. The effect of elevated HbA1c on a number of clinical outcomes and all-cause mortality was assessed in Cox regression models. RESULTS: At diagnosis, 97 patients (8.5%) had an HbA1c level within normal range. Age (mean (SD)) at diagnosis was 64.5 (11.5) years. Both unadjusted and adjusted hazard ratios for the effect of HbA1c on mortality and other outcomes were not statistically significant. CONCLUSIONS: Patients who are diagnosed with type 2 diabetes mellitus by means of elevated fasting whole blood/plasma glucose but have HbA1c within reference range at diagnosis do not seem to have a relatively benign long-term clinical course. Therefore new diagnostic procedures should preferably be able to identify these individuals.

Weight history of patients with newly diagnosed Type 2 diabetes.

AIMS: To estimate and illustrate how the 10 years of weight change immediately preceding diabetes diagnosis vary with weight at the age of 20 years and with socio-demographic variables, risk factors and comorbidities at diagnosis. METHODS: Data were from a population-based cohort of 1320 persons newly diagnosed with diabetes aged > or = 40 years. Patients' weight at diagnosis was measured by the doctor, while patients recalled their weight approximately 1, 5 and 10 years prior to diagnosis and at age 20 years. RESULTS: Median weight gain from age 20 years to diabetes diagnosis at median age 65.3 years was 14.7 kg (interquartile range 6.0-23.0). Women gained weight more than men, and the lower the weight at age 20 years, the greater the weight gain. The average weight gain from 10 years prior to diabetes diagnosis until diagnosis, however, was only 1 kg and decreased markedly with age. These 10 years of weight change were also associated with sex and the following baseline characteristics: diagnostic plasma glucose, urinary glucose, urinary albumin, fasting triglycerides, systolic blood pressure, smoking habits, and presence of diabetic retinopathy. CONCLUSIONS: The results add to the evidence that it is important to advise young patients in particular, especially women, who have gained and sustained considerable weight to curb this upward weight trend in order to prevent the development of diabetes.

Relationship of glucose concentrations with PAI-1 and t-PA in subjects with normal glucose tolerance.

AIM: To study metabolic risk factors for the development of cardiovascular disease (CVD), including markers of the fibrinolytic system in relation to blood glucose levels in subjects with normal glucose tolerance and fasting blood glucose levels below 5.6 mmol/l. METHODS: Cross-sectional, community-based study from a primary health-care centre of adult subjects with normal glucose tolerance. Analysis of fasting and 2-h post-load blood glucose concentrations were centralized and related to anthropometric characteristics, metabolic variables, inflammatory markers, and coagulation and fibrinolytic variables. RESULTS: Increasing fasting blood glucose concentrations within the normal range in subjects with normal glucose tolerance were associated with increasing age, body mass index, and waist circumference, and with increasing concentrations of metabolic risk factors for development of CVD. After adjustment for gender, age, body mass index (BMI), and fasting insulin, levels of plasmin activator inhibitor (PAI-1) and tissue type plasminogen activator (t-PA) increased significantly with increasing levels of fasting glucose within the normal range (P = 0.012 and P < 0.0001, respectively). CONCLUSIONS: We found risk factors for CVD, specifically key components of the fibrinolytic system, PAI-1 and t-PA, increased with increasing fasting glucose levels even in subjects with normal glucose tolerance. This observation may help to explain the increased risk of CVD with increasing values of fasting glucose in the normal range.

Changes in patient weight and the impact of antidiabetic therapy during the first 5 years after diagnosis of diabetes mellitus.

AIMS/HYPOTHESIS: It is generally thought difficult for type 2 diabetic patients to lose weight. We monitored changes in patients' weight during the first 5 years after diabetes diagnosis in relation to initiation of antidiabetic treatment. SUBJECTS AND METHODS: Data from 711 newly diagnosed diabetic patients aged 40 or over were analysed with a random-effect linear-regression model. Patients were included consecutively from a well-defined patient list in general practice. RESULTS: In 245 patients whose only treatment was advice on diet, an initial weight loss of 6 to 7 kg was largely maintained over 5 years. Patients receiving metformin (n=86) or sulfonylureas (n=330) maintained an average weight loss of 2 to 4 kg that was dependent on age and sex. Patients' weight did not change on initiation of treatment with sulfonylureas or metformin. Over 5 years, median HbA(1c) increased from 7.0 to 7.8% (reference range 5.4-7.4%) in the diet-alone group. HbA(1c) was approximately 1 percentage point higher for most of the other treatment groups. CONCLUSIONS/INTERPRETATION: In newly diagnosed type 2 diabetic patients, long-term weight loss was common and weight loss was not affected by sulfonylurea treatment. The measurements in the study are taken from treatment results achieved in the general population of diabetic patients, who are rarely treated in secondary care and seldom the subject of research; the results thus indicate that weight reduction is a practicable treatment in diabetic patients.

Routine diagnosis of Type 2 diabetes mellitus in general practice and hospitals: how do patients differ?

OBJECTIVE: To study how Type 2 diabetic patients diagnosed by routine case-finding in primary care differ from patients diagnosed in secondary care with regard to clinical characteristics, symptom-burden and prevalence of complications. RESEARCH DESIGN AND METHODS: A Danish population-based sample of 1633 newly diagnosed Type 2 diabetic patients, of whom we had detailed information of sociodemographic and clinical characteristics, biochemical measurements, and complications among 1381. Blood and urine analyses were centralized. RESULTS: Of the patients, 76.8% were diagnosed in general practice. Compared with those diagnosed in secondary care, patients diagnosed in general practice on average had higher levels of cardiovascular risk factors (BMI: 29.8 vs. 28.5 kg/m2, P < 0.001; systolic blood pressure: 149.4 vs. 143.2 mmHg, P < 0.001; diastolic blood pressure: 85.2 vs. 82.5 mmHg, P < 0.001; haemoglobin A(1c): 10.1 vs. 8.4%, P < 0.0001; total cholesterol: 6.4 vs. 6.1 mmol/l, P < 0.01), more frequently presented with hyperglycaemic symptoms (80.1 vs. 63.4%, P < 0.0001), while fewer had macrovascular complications (28.5 vs. 43.6%, P < 0.0001). CONCLUSIONS: Judged from their risk profile, Type 2 diabetic patients diagnosed in primary care are at no less risk of developing diabetic complications than those diagnosed in secondary care.

Symptoms, signs and complications in newly diagnosed type 2 diabetic patients, and their relationship to glycaemia, blood pressure and weight.

AIMS/HYPOTHESIS: To document the prevalence of typical diabetic symptoms, signs and complications in the diagnosis of type 2 diabetes mellitus, examine their pre-diagnostic duration, and analyse associations with glycaemic level, blood pressure (BP), and weight. METHODS: An epidemiological population-based study of 1137 Danish patients with type 2 diabetes newly diagnosed by general practitioners (GPs). GPs and patients together filled in a questionnaire about typical symptoms, signs and complications preceding the diagnosis. RESULTS: Abnormal thirst, frequent urination, weight loss, genital itching, stomatitis, visual disturbances, fatigue, confusion and (in men) balanitis were associated with glycaemic level irrespective of age, sex, BMI, BP, complications and antihypertensive treatment. Eighty-nine percent of the patients presented with one or more of these hyperglycaemic symptoms and signs, and the pre-diagnostic duration was typically less than 3 months. Only a few symptoms, signs and complications were associated with weight and BP. CONCLUSIONS/INTERPRETATION: In patients newly diagnosed with type 2 diabetes in family practice, typical diabetic symptoms, signs and complications are common. Typical diabetic symptoms and signs are associated with hyperglycaemia. The pre-diagnostic duration of hyperglycaemic symptoms and signs were typically short, thus questioning the feasibility of early detection relying on increased anticipatory care by GPs. In contrast, elevated levels of cardiovascular risk factors and longer pre-diagnostic duration of cardiovascular complications suggest these might have a central role in an early diagnosis of type 2 diabetes.

Peripheral vascular disease is associated with reduced glycosuria in newly diagnosed type 2 diabetic patients.

OBJECTIVES: We examined whether the finding of glycosuria and its level in themselves give information of clinical relevance, apart from being an unreliable indicator of glycemic control. METHODS: Subjects were a population-based sample of 1,284 newly diagnosed type 2 diabetic patients. Median age was 65.2 years. Urinary glucose concentration (UGC) was determined quantitatively in a freshly voided morning urine specimen. RESULTS: The over-all prevalence of peripheral vascular disease (PVD) was 16.5%. Bivariately, high values of UGC were associated with low prevalence of PVD (p<0.001, chi2-test). The predictive value of PVD--together with HbA1c, glomerular filtration rate (GFR) and 10 other possible predictors--was confirmed in a logistic regression analysis with glycosuria (Y/N) as outcome variable (p=0.0004). CONCLUSION: Surprisingly, type 2 diabetic patients with PVD tend not to have glycosuria as compared to patients without PVD. PVD may be indicative of generalized atherosclerotic lesions in the major vessels, including the renal arteries. This could lead to a lowering of GFR and thereby of the amount of glucose filtered. Assuming no, or only a minor direct effect of PVD on tubular function, this would lead to an increased renal threshold for glucose in patients with PVD.

Impaired fasting glycaemia resembles impaired glucose tolerance with regard to cardiovascular risk factors: population-based, cross-sectional study of risk factors for cardiovascular disease.

AIMS: To compare subjects with impaired glucose tolerance and impaired fasting glucose in relation to risk factors for developing cardiovascular disease. METHODS: A total of 1374 patients (678 female, 696 male) listed with a general practice clinic in Denmark were given an oral glucose tolerance test, a physical examination, and a self-administered questionnaire. Risk factors for cardiovascular disease were assessed for 90 participants (48 female, 42 male) with impaired glucose tolerance (including 12 subjects (1 female and 11 male), who also fulfilled criteria for impaired fasting glycaemia) and 51 subjects (20 female, 31 male) with impaired fasting glycaemia (World Health Organization 1999 criteria). RESULTS: There were no statistical differences with regard to known risk factors for cardiovascular disease between participants with isolated impaired fasting glycaemia and those with impaired glucose tolerance. CONCLUSIONS: We found noticeable similarities in the cardiovascular risk factor profile in subjects with impaired fasting glycaemia and in subjects with impaired glucose tolerance in our population. When planning screening initiatives, it seems relevant to take into account people with impaired fasting glycaemia as well as those with impaired glucose tolerance.

Can capillary whole blood glucose and venous plasma glucose measurements be used interchangeably in diagnosis of diabetes mellitus?

According to new proposals from the American Diabetes Association (ADA) and WHO, venous peripheral plasma is the preferred system for measuring glucose for diagnosing diabetes mellitus. Owing to the instability of glucose in plasma after blood sampling, strict well-defined and standardized preanalytical conditions are essential to ensure that glucose concentration measured in plasma reflects real blood glucose in the patient. This is in contrast to the capillary whole blood measurements, which are easy to perform and well established. We investigated whether it is possible to perform analysis on capillary whole blood but express the results as plasma glucose values and hence obtain comparable results and the same predictive values for diagnosis in the individual patient? The conclusion of our investigations is that these two systems are not interchangeable and that conversion should not be done for diagnostic purposes where plasma determinations are recommended.

Upper reference limit, analytical quality specifications and clinical use of haemoglobin A1C.

Haemoglobin A1c (HbA1c) is now the key component for monitoring glycaemic control in diabetes mellitus (DM), especially for its close relation to diabetes complications. However, treatment goals in terms of HbA1c concentrations have been difficult to define and compare because of lack of international standardization and lack of common reference values of HbA1c concentrations. The aims of our study were to document our HbA1c analysis and make it traceable to international reference laboratories with the aid of current reference preparations, to establish a reference interval based on a low-risk population, and to evaluate the analytical quality specifications, which could meet clinical needs. The s(analytical) of our method (Tosoh) was < 0.3 HbA1c%, and the mean bias as estimated from Dr Cas Weykamp's reference preparation was below 0.3 HbA1c. This was the same as that for participating Scandinavian and international reference laboratories. The concentrations were made traceable to results from the Diabetes Control and Complication Trial (DCCT) and the UK Prospective Diabetes Study (UKPDS). Risk groups for DM were ruled out from a randomly selected population in Vejle County, which isolated a "low-risk" reference population. The 97.5 reference interval in this population (N=430) was from 5.07 HbA1c% (95% CI: 5.02-5.11) to 6.24 HbA1c% (95% CI: 6.19-6.30), and the 99.9 centile was 6.62 HbA1c% (95%) CI 6.55-6.71). Body mass index, age and gender contributed marginally to the level of HbA1c concentrations. A 10% delta risk estimate of DM complications was detectable with a probability of Type I error of 40%, while adoption of a significance level of 95% and consideration to biological variation needed a risk difference of at least 33% to be detected. The critical difference was 11% for changes in either direction at s(analytical) < or = 0.2 HbA1c% and a s(biological) of 0.3 HbA1c%. Based on criteria for sharing common reference intervals and clinical utility, we accepted that the bias and s(analytical) should both be < 0.3 HbA1c% at the level of 7.0 HbA1c%.

Diabetic retinopathy in newly diagnosed middle-aged and elderly diabetic patients. Prevalence and interrelationship with microalbuminuria and triglycerides.

BACKGROUND: The exact role of factors such as serum lipids, body mass index and (micro-)albuminuria as possible determinants of diabetic retinopathy remains to be determined. We have scrutinized the prevalence of diabetic retinopathy and its concomitants in terms of risk factors and other diabetic complications in newly diagnosed diabetic patients. METHODS: A population-based sample of 1,251 newly diagnosed diabetic patients aged 40 years or over was established in general practice. Median age was 65.3 years. Funduscopy was performed by practising ophthalmologists. Blood and urine analyses were centralised. RESULTS: The overall prevalence of diabetic retinopathy was 5.0%. Only three patients had proliferative diabetic retinopathy. As expected, diabetic retinopathy and renal involvement, as expressed by the urinary albumin/creatinine ratio. were strongly positively associated. An intriguing finding was that of an inverse relationship between fasting triglycerides and diabetic retinopathy, an association that proved to be confined to microalbuminuric patients. An inverse association between body mass index and diabetic retinopathy was found only univariately. CONCLUSION: The low prevalence of diabetic retinopathy cannot be explained by the screening method alone, but rather by early detection of diabetes in a non-selective patient sample. It seems that renal involvement modifies the expected relationship between diabetic retinopathy and triglycerides, but a pathophysiological mechanism is not available.

[Randomized controlled trial of structured, individualized treatment of type 2 diabetes mellitus. The project of Diabetes Care in General Practice]. / Randomiseret kontrolleret undersøgelse af struktureret, individualiseret behandling af type 2-diabetes mellitus. Projektet Diabetesomsorg i almen praksis.

INTRODUCTION: We assessed the effect of a multifaceted intervention directed at general practitioners to improve type 2 diabetes care. MATERIALS AND METHODS: Three hundred and eleven Danish practices with 474 general practitioners were randomised to structured personal care (intervention group) or routine care (comparison group). Of 970 surviving patients (aged 40+ years) diagnosed with diabetes in 1989-1991, 874 (90.1%) were assessed after 6 years. Intervention comprised regular follow-up and individualized goal-setting, supported by reminders to doctors, clinical guidelines, feed-back, and continuing medical education. RESULTS: Predefined non-fatal outcomes and mortality were the same in both groups. The following risk factor levels were lower in the intervention patients than in the comparison patients: fasting plasma glucose (7.9 vs 8.7 mmol/l, medians, P = 0.0007), haemoglobin A1c (8.5 vs 9.0%, P < 0.0001, normal range 5.4-7.4%), systolic blood pressure (145 vs 150 mmHg, P = 0.0004), and cholesterols (6.0 vs 6.1 mmol/l, P = 0.029, baseline-adjusted). Both groups had sustained a weight loss since diagnosis (2.6 vs 2.0 kg). Metformin was the only drug used more frequently in the intervention group (24 vs 15%). Intervention doctors arranged more follow-up consultations, referred fewer patients to diabetes clinics, and were more optimistic in their goal-setting. DISCUSSION: In primary care, individualized goal-setting with educational and surveillance support may for at least six years bring risk factors of patients with type 2 diabetes to a level that in other trials has been shown to reduce diabetic complications, but without adverse weight gain.

Randomised controlled trial of structured personal care of type 2 diabetes mellitus.

OBJECTIVE: To assess the effect of a multifaceted intervention directed at general practitioners on six year mortality, morbidity, and risk factors of patients with newly diagnosed type 2 diabetes. DESIGN: Pragmatic, open, controlled trial with randomisation of practices to structured personal care or routine care; analysis after 6 years. SETTING: 311 Danish practices with 474 general practitioners (243 in intervention group and 231 in comparison group). PARTICIPANTS: 874 (90.1%) of 970 patients aged >/=40 years who had diabetes diagnosed in 1989-91 and survived until six year follow up. INTERVENTION: Regular follow up and individualised goal setting supported by prompting of doctors, clinical guidelines, feedback, and continuing medical education. MAIN OUTCOME MEASURES: Predefined clinical non-fatal outcomes, overall mortality, risk factors, and weight. RESULTS: Predefined non-fatal outcomes and mortality were the same in both groups. The following risk factor levels were lower for intervention patients than for comparison patients (median values): fasting plasma glucose concentration (7.9 v 8.7 mmol/l, P=0.0007), glycated haemoglobin (8.5% v 9.0%, P<0.0001; reference range 5.4-7.4%), systolic blood pressure (145 v 150 mm Hg, P=0.0004), and cholesterol concentration (6.0 v 6.1 mmol/l, P=0.029, adjusted for baseline concentration). Both groups had lost weight since diagnosis (2.6 v 2.0 kg). Metformin was the only drug used more frequently in the intervention group (24% (110/459) v 15% (61/415)). Intervention doctors arranged more follow up consultations, referred fewer patients to diabetes clinics, and set more optimistic goals. CONCLUSIONS: In primary care, individualised goals with educational and surveillance support may for at least six years bring risk factors of patients with type 2 diabetes to a level that has been shown to reduce diabetic complications but without weight gain.