The National Diabetes Register in Sweden: an implementation of the St. Vincent Declaration for Quality Improvement in Diabetes Care

OBJECTIVE: To monitor glycemic control, treatable risk factors, and treatment profile for quality assessment of diabetes care on a national scale. RESEARCH DESIGN AND METHODS: Four samples of 23,546, 32,903, 30,311, and 29,769 patients with diabetes (1996-1999) were studied based on a repeated national screening and quality assessment of diabetes care by the National Diabetes Register, Sweden, with participation of both hospitals and primary health care. Clinical characteristics included were age, sex, diabetes duration and treatment, glycemic control (HbA(1c)), office blood pressure (BP), BMI, smoking habits, and use of lipid-lowering drugs in patients with type 1 or type 2 diabetes. RESULTS: Favorable decreases of mean HbA(1c) and BP values were registered during the 4-year study period for both type 1 (HbA(1c) 7.5-7.3% and BP 130/75-130/74 mmHg) and type 2 diabetic patients (HbA(1c) 7.0-6.7% and BP 151/82-147/80 mmHg). Treatment aims of HbA(1c) and BP levels were also achieved in increasing proportions for type 1 (HbA(1c) <7.5%: 50-58% and BP 相似文献   

Control of cardiovascular risk factors in patients with diabetes and hypertension at urban academic medical centers

OBJECTIVE: There are national mandates to reduce blood pressure (BP) to <130/85 mmHg, LDL cholesterol to <100 mg/dl, and HbA(1c) to <7% and to institute aspirin therapy in patients with diabetes. The objective of this study was to determine the proportion of patients in urban institutions with diabetes and hypertension who meet these treatment goals. RESEARCH DESIGN AND METHODS: Using American Diabetes Association (ADA) guidelines, we evaluated the control of cardiovascular disease (CVD) risk factors in 1,372 patients receiving medical care at two major urban medical centers in Brooklyn and Detroit. Information was extracted from charts of outpatient clinics. RESULTS: Of 1,372 active clinic patients with diabetes and hypertension, 1,247 (90.9%) had type 2 diabetes, and 26.7% met the target blood pressure of 130/85 mmHg. A total of 35.5% met the goal LDL cholesterol level of <100 mg/dl, 26.7% had an HbA(1c) <7%, and 45.6% were on antiplatelet therapy. Only 3.2% of patients met the combined ADA goal for BP, LDL cholesterol, and HbA(1c). CONCLUSIONS: Optimal control of CVD risk factors in adults with diabetes was achieved only in a minority of patients. Results reflect the inherent difficulties in achieving these complex guidelines in our present health care systems.     

Risk of developing retinopathy in Diabetes Control and Complications Trial type 1 diabetic patients with good or poor metabolic control.

OBJECTIVE: The study goal was to assess and predict the risk of developing retinopathy in type 1 diabetic patients with extreme metabolic control. RESEARCH DESIGN AND METHODS: Based on material from the Diabetes Control and Complications Trial (DCCT) study (n = 1,441 patients), patients without retinopathy at baseline (DCCT primary cohort) were considered under good or poor metabolic control if the mean HbA(1c) level (until the last visit) fell in the lower or upper 20% of the overall HbA(1c) distribution, respectively. Retinopathy was recorded as either absent or present. Logistic regression was used to predict retinopathy from covariates used in the DCCT retinopathy study. RESULTS: Among the 153 DCCT patients with "good metabolic control" (mean HbA(1c) < or = 6.87%), three-step change retinopathy developed in 15 (9.8%), and 138 (90%) remained free of retinopathy. Conversely, among the 166 patients with "poor metabolic control" (mean HbA(1c) > or = 9.49%), the complication did not develop in 71 (43%) and did develop in 95 (57%). Whereas occurrence of diabetic retinopathy was primarily due to metabolic control (P < 0.0001) and duration of participation in the study (P < 0.0001), two other covariates were found to be significant prognostic factors of the complication: HbA(1c) at baseline (OR 1.37, P < 0.001) and BMI (OR 1.11, P < 0.05). CONCLUSIONS: This study confirms that retinopathy develops in approximately 10% of patients with type 1 diabetes under good metabolic control, whereas > 40% of patients with type 1 diabetes remain free of retinopathy despite poor metabolic control. After adjusting for metabolic control and duration of participation in the study, it was found that previous glycemic exposure (HbA(1c)) and BMI may provide a possible explanation to such paradoxical clinical situations.     

CA6-02: Collaborative Goal Setting and HbA1c Control Among Patients With Diabetes

Background/Aims Helping patients set and follow up on goals may be an effective way to help patients improve their confidence (self-efficacy) and commitment to improve diabetes self- management. We evaluate associations among patient-reported use of collaborative goal setting with clinicians, patient-reported self-efficacy, and clinical control (measured by HbA1c) among patients with diabetes. Methods A cohort of insured patients aged 18+ years with diabetes who initiated oral mono-therapy between 2000-2005 was surveyed in 2008. The survey included the 3 collaborative goal-setting items from the Patient Assessment of Chronic Illness Care (PACIC), a 4-item measure of self-efficacy, measures of socio-demographics, age of diabetes onset, and height/weight. Survey data were joined with automated laboratory and encounter data for the 12 months prior to and following survey administration. A structural equation model (SEM), using path analysis and adjusting for baseline patient characteristics (including HbA1c and diabetes-related co-morbidities and complications), was fit to investigate relationships among collaborative goal setting, self-efficacy and HbA1c control. Results Completed surveys were available for 1070 patients (n=956 mail and n=114 telephone; 77% response rate). Survey respondents were on average 68 years, half were female, 60% white, 31% black, and 57% reported low self-efficacy. On average, patients reported engaging in collaborative goal setting with their clinicians 'sometimes' (mean = 3.1, range 1 [never]-5 [always]). At baseline, mean HbA1c was 7.2%, with 22% =8%. Results from the SEM did not support a direct relationship between the collaborative goal setting factor (Cronbach Alpha=0.83) and HbA1c control, but did support an indirect relationship (asymmetric distribution of products 95% CI = -0.02, -0.002) with increases in collaborative goal setting positively associated with a greater likelihood of average or high self-efficacy (beta, p<0.01), and average or high self-efficacy associated with lower follow-up HbA1cs level (-beta, p<0.01). These relationships persisted after controlling for baseline HbA1c and other patient characteristics. Discussion While collaborative goal setting between patients with diabetes and their clinicians is not directly associated with better clinical control, it is associated with improved self-efficacy, which in turn, is associated with improved clinical control.     

Encouraging structured personalised diabetes care in general practice. A 6-year follow-up study of process and patient outcomes in newly diagnosed patients

OBJECTIVE: To evaluate the quality of diabetes care achieved on the process and outcomes of care in the context of a multifaceted intervention directed at general practitioners (GPs) encouraging regular follow-up and individualised goal-setting. DESIGN: A 6-year follow-up study. SETTING: A total of 243 Danish GPs and a population-based sample of 729 newly diagnosed, predominantly type 2 diabetic patients participated. MAIN OUTCOME MEASURES: Questionnaires and laboratory assessments were used to determine the proportion of patients reviewed regularly, and their pharmacological treatment and risk factors. RESULTS: During the study, the proportion of patients who had an annual clinical examination decreased from 100% to 77%. The proportion given oral anti-diabetic agents or insulin increased from 43% to 71%. Median glycated haemoglobin (HbA1c) dropped in the 2nd year to 7.7% (normal range 5.4-7.4%), after which it increased gradually, but remained on average at 1.3% above the upper limit of the normal range. Median blood pressure (systolic/diastolic), total cholesterols and fasting triglycerides were maintained at 145-150/81-85 mmHg, 6.0-6.2 mmol/l and 1.66-1.96 mmol/l, respectively. Initial weight loss was partly regained over 6 years. CONCLUSION: Among centrally supported GPs, most patients were regularly reviewed and obtained acceptable levels of risk factors for at least 6 years, although glycaemic control progressively deteriorated after an initial drop to near-normal average level.     

Adequacy of glycemic, lipid, and blood pressure management for patients with diabetes in a managed care setting

OBJECTIVE: We conducted a retrospective study to evaluate the adequacy of glycemic, lipid, and blood pressure (BP) management for diabetic patients in a managed care organization (MCO). RESEARCH DESIGN AND METHODS: Patients aged > or =18 years with diabetes (n=7,114) were retrospectively identified over a 2-year period from the MCO's administrative database based on the Health Plan Employer Data and Information Set 2000 selection criteria using pharmacy, laboratory, and encounter data. Analyses examined demographics and percentages of patients tested and meeting American Diabetes Association goals for HbA1c, lipids, and BP, both overall and for those receiving medication treatment versus no treatment. RESULTS: Testing rates for A1C, LDL cholesterol, and BP were 77, 54, and 95%, respectively. The percentage of patients tested who were at goal were 37% for A1C, 23% for LDL cholesterol, and 41% for systolic BP. Of the patients in our sample, 72% were treated for glycemic control, 64% were treated for BP control, and only 28% were treated for lipid control. Of the patients who received medication treatment, less than one-third were at goal for A1C (29%) and LDL cholesterol (32%), whereas 40% were at goal for systolic BP. CONCLUSIONS: We found that although a large percentage of diabetic patients were tested for A1C, LDL cholesterol, and systolic BP, a much smaller percentage had reached their respective goals. More aggressive glycemic, lipid, and BP management appears to be needed to improve care for these patients.     

口服降糖药治疗的2型糖尿病患者血糖和血脂控制情况的联系

目的观察中国口服降糖药治疗的2型糖尿病患者血糖和血脂控制情况,初步探讨二者间的联系及其可能机制。方法全国16家三甲医院于2007年1～6月对455名2型糖尿病患者采用统一的亚太地区糖尿病治疗实际疗效和治疗模式(APRECAP-DM)研究患者问卷进行病史采集,体格检查并采血送中心实验室检测血糖等生化指标。结果血糖控制不良(HbA1c≥6.50%)的患者中,TG>1.70mmol/L者占52.81%,其中96.03%未使用贝特类药。稳健回归模型校正了BMI、运动情况、病程、HOMA-β和口服降糖药的种类数后,TG、TG/HDL对血糖控制水平有正向影响(β=0.091,P=0.030;β=0.112,P=0.012),HDL对其有负向影响(β=-0.407,P=0.004),而LDL对其的影响无统计学意义(P=0.679)。考察因素间的二阶交互作用,发现病程和TG,病程和TG/HDL间的交互作用(P=0.005;P=0.016)具有统计学意义。根据病程分层分析,TG、TG/HDL和血糖控制的联系主要存在于病程>5年时。TG、HDL、TG/HDL与胰岛素抵抗间具有剂量反应关系(P均<0.001)。结论血脂谱中TG、HDL、TG/HDL和血糖控制水平相关,尤其在病程较长时,机制可能涉及胰岛素抵抗。2型糖尿病患者中血脂不达标者较多,但是调脂药使用者较少,提示我们注意控制血糖的同时要及早干预血脂代谢紊乱。     

Blood pressure does not rise before the onset of microalbuminuria in children followed from diagnosis of type 1 diabetes. Oxford Regional Prospective Study Group

OBJECTIVE: To examine whether a rise in blood pressure could be detected before the onset of microalbuminuria (MA) in a cohort of children followed from diagnosis of type 1 diabetes. RESEARCH DESIGN AND METHODS: The Oxford Regional Prospective Study is an incident cohort study of children with type 1 diabetes aged (mean +/- SD) 9.8 +/- 3.7 years at diagnosis. Subjects were assessed annually from diagnosis, with measurement of HbA1c, arterial blood pressure (random zero), and three urine samples for estimation of the albumin/creatinine ratio. During follow-up, 63 of 494 children developed MA at one or more annual assessments and were designated as cases for a nested case-control study. Each case was matched for sex and age at diagnosis with two normoalbuminuric control subjects. Blood pressure (BP) data were compared at corresponding years of diabetes duration. RESULTS: Cases with MA were similar to normoalbuminuric control subjects with respect to age and BMI, but they had higher mean HbA1c levels (mean difference 1.1%, P < 0.001). In the years before the onset of MA, the diastolic BP standard deviation score (SDS) was significantly higher than zero in cases (mean 0.49, P < 0.001) and in control subjects (0.50, P < 0.001). No difference could be detected between cases and control subjects before the onset of MA in either systolic or diastolic BP (mean difference systolic -1.2 mmHg [95% CI -4.7 to 2.7], mean difference diastolic 0.1 mmHg [-2.4 to 2.6]). However, within the cases, the onset of MA was associated with elevations in systolic and diastolic BP SDSs (F = 16.1, P < 0.001; and F = 18.0, P < 0.001). BMI, but not HbA1c, was associated with systolic and diastolic BP SDSs in the subjects with MA (F = 0.6, P = 0.4; and F = 12.3, P = 0.001). However, the association of BP with MA remained signifcant for systolic BP (P = 0.001) and for diastolic BP (P < 0.001) after adjusting for BMI. CONCLUSIONS: A rise in systemic BP cannot be detected before the first appearance of MA in children with type 1 diabetes. BP rises concurrently with the onset of MA and is also closely related to BMI.     

Impact of computer-generated personalized goals on HbA(1c).

OBJECTIVE: The public is increasingly aware of the importance of HbA(1c) testing, yet the vast majority of patients with diabetes do not know their HbA(1c) status or goal. We set forth to evaluate the impact of a system that provides uniquely formatted and personalized reports of diabetes status and goals on changes in HbA(1c) levels. RESEARCH DESIGN AND METHODS: A total of 150 patients with diabetes were randomized to receive either standard care or intervention inclusive of a computer-generated 11" x 17" color poster depicting an individual's HbA(1c) status and goals along with personalized steps to aid in goal achievement. All patients enrolled received diabetes education during the 3 months before enrollment. HbA(1c) was performed at baseline and 6 months. RESULTS: At baseline, there were no significant differences between patient groups in terms of age, sex, education level, race, and HbA(1c) or lipid levels. Among patients with baseline HbA(1c) > or =7.0%, there was an 8.6% (0.77% absolute) reduction in HbA(1c) among control subjects compared with a 17.0% (1.69% absolute) decline in the intervention group (P = 0.032). There were no differences between the control and intervention groups with respect to the frequency of patients experiencing any decline in HbA(1c) (63 vs. 69%, P = 0.87); among these patients experiencing a decline, the most substantial reductions were seen with the control group, which had a 13.3% (1.15% absolute) decline compared with the intervention patients, who reduced their HbA(1c) by 24.2% (2.26% absolute reduction; P = 0.0048). At study close, 77% of the patients had their poster displayed on their refrigerator. CONCLUSIONS: This unique and personalized computer-generated intervention resulted in HbA(1c) lowering comparable to that of hypoglycemic agents.     

Vildagliptin: clinical trials programme in monotherapy and combination therapy for type 2 diabetes

As part of an extensive clinical development programme in patients with type 2 diabetes (T2DM), vildagliptin 50 mg once daily and twice daily, and 100 mg once daily have been assessed in placebo-controlled and, more importantly, in head-to-head active-comparator monotherapy trials over a wide range of baseline HbA1c levels and in a large number of elderly patients. Notable findings in individual trials included: comparable HbA1c lowering over 24 weeks with 100 mg once daily or 50 mg twice daily; efficacy comparable to rosiglitazone with reduced risk of weight gain and oedema over 24 weeks; and durable glycaemic control for up to 2 years with a reduced frequency of gastrointestinal adverse events compared with metformin. Pooled monotherapy data indicate that vildagliptin 100 mg daily produces consistent and clinically meaningful reductions in HbA1c across a range of initial HbA1c levels, in patients with lower and greater body mass index, and in younger and older patients. To date, the safety/tolerability profile seems comparable to placebo with neutral effects on body weight and lipid profiles, and minimal risk of hypoglycaemia. A preliminary study in subjects with impaired glucose tolerance showed that vildagliptin 50 mg once daily enhanced islet cell function, reduced glycaemic excursions and was very well tolerated, paving the way for a future trial in diabetes prevention. Vildagliptin has also been extensively studied in multiple clinical scenarios as add-on combination therapy in patients with inadequate glycaemic control on metformin, thiazolidinedione, sulfonylurea and insulin treatment, and has consistently been shown to improve glycaemic control with good tolerability and low risk for hypoglycaemia. In a trial in patients receiving metformin, the addition of vildagliptin 50 mg twice daily resulted in a 1.1% reduction in HbA1c at 24 weeks. Compared with add-on pioglitazone 30 mg daily in patients inadequately controlled with ongoing metformin therapy, vildagliptin 50 mg twice daily reduced HbA1c by 0.9% vs. 1.0% and was not associated with weight gain (+0.3 kg vs. +1.9 kg) over 24 weeks. Most notably, vildagliptin plus pioglitazone as initial combination therapy in drug-naive patients resulted in robust HbA1c reductions of 1.9% from baseline. In patients receiving stable insulin therapy, vildagliptin 50 mg twice daily improved glycaemic control and was associated with a significant reduction in hypoglycaemic episodes over 24 weeks. Vildagliptin shows considerable promise as a partner for metformin and other commonly used oral antidiabetic agents, and may well play an important role in combination with insulin therapy to further improve glycaemic control.     

Intensified treatment of type 2 diabetes--positive effects on blood pressure, but not glycaemic control

BACKGROUND: Since publication of the UK Prospective Diabetes Study (UKPDS) in 1998, there has been a clear evidence base for tight glycaemic (HBA(1c) < 7.0%) and blood pressure (BP < 140/85 mmHg) control. AIM: To determine the effect of UKPDS-based intensified glycaemic and BP targets on the care of type 2 diabetic patients attending a routine diabetes clinic. DESIGN: Two surveys, each of 500 consecutively attending type 2 diabetic patients. METHODS: The first survey was in a 3-month period in 1999, shortly after publication of the UKPDS study. The second was identical, but 2 years later. Glycaemic control (by DCCT-aligned HBA(1c)), BP and treatment details were recorded in both. RESULTS: BP control was significantly improved in the second survey (mean +/- SD systolic BP from 151 +/- 25 to 146 +/- 26 mmHg, p = 0.001; diastolic from 77 +/- 13 to 72 +/- 12 mmHg, p < 0.0001) and the proportion of patients on anti-hypertensive treatment increased from 33% to 60% (p < 0.0001). Mean HbA(1c) however remained unchanged (8.7 +/- 1.8% in 1999 vs. 8.5 +/- 1.8% in 2001), although there was evidence of more intensive treatment patterns, with declining numbers on diet alone and more on oral agents and/or insulin. DISCUSSION: Intensified BP control may be achievable within the confines of routine diabetes care, but achievement of optimal glycaemic targets remains problematic.     

The potentially poor response to outpatient diabetes care in urban African-Americans

OBJECTIVE: HbA1c levels can be reduced in populations of diabetic patients, but some individuals may exhibit little improvement. To search for reasons underlying differences in HbA1c outcome, we analyzed patients managed in an outpatient diabetes clinic. RESEARCH DESIGN AND METHODS: African-Americans with type 2 diabetes were categorized as responders, intermediate responders or poor responders according to their HbA1c level after 1 year of care. Logistical regression was used to determine baseline characteristics that distinguished poor responders from responders. Therapeutic strategies were examined for each of the response categories. RESULTS: The 447 patients had a mean age and disease duration of 58 and 5 years, respectively, and BMI of 32 kg/m2. Overall, the mean HbA1c level fell from 9.6 to 8.1% after 12 months. Mean HbA1c levels improved from 8.8 to 6.2% in responders, and from 9.5 to 7.9% in intermediate responders. In poor responders, the average HbA1c level was 10.8% on presentation and 10.9% at 1 year. The odds of being a poor responder were significantly increased with longer disease duration, higher initial HbA1c level, and greater BMI. Although doses of oral agents and insulin were significantly higher among poor responders at most visits, the acceleration of insulin therapy did not occur until late in the follow-up period. CONCLUSIONS: Clinical diabetes programs need to devise methods to identify patients who are at risk for persistent hyperglycemia. Whereas patient characteristics explain some heterogeneity of HbA1c outcome (and may aid in earlier identification of patients who potentially may not respond to conventional treatment), insufficient intensification of therapy may also be a component underlying the failure to achieve glycemic goals.     

Improving life expectancy and decreasing the incidence of complications associated with type 2 diabetes: a modelling study of HbA1c targets

To project the long-term clinical and cost outcomes that accompany predefined improvements in glycaemic control in patients with type 2 diabetes. A peer-reviewed, validated, non-product-specific Markov model of type 2 diabetes was used to project the long-term clinical and cost outcomes associated with three HbA1c reduction scenarios (vs. no reduction): (i) decreasing mean HbA1c from 9.5% to 8.0%; (ii) from 8.0% to 7.0%; and (iii) from 7.0% to 6.5%. A typical baseline US type 2 diabetes cohort derived from National Health and Nutrition Examination Survey data was simulated over a lifetime horizon (35 years). Incidence of diabetes-related complications and costs (2005 USD) were accounted based on published data. Discount rates (3% per annum) were applied to clinical benefits and costs. Sensitivity analyses were performed. Stepwise reductions in HbA1c as an independent variable correlated with delayed time to diabetes-related complications and a reduced cumulative incidence of complications, including cardiovascular, renal and neurologic comorbidities. Related costs also decreased. Reductions in both poorly- (9.5-8.0%) and better-controlled (7.0-6.5%) patients produced incremental gains in undiscounted life expectancy (LE) [1.06 (0.31) and 0.32 (0.34) years [mean (SD)], respectively]. Similar improvement patterns were observed in quality-adjusted life expectancy (QALE). Benefits from sequential reduction scenarios, when aggregated, exhibited the most dramatic effect. Improved glycaemic control was associated with reductions in complication rates and costs, as well as increased LE and QALE among type 2 patients. These data illustrate the long-term importance of reaching normoglycaemia and support intensified HbA1c control as a cornerstone of effective long-term type 2 diabetes management.     

Cost and benefits of a multidisciplinary intensive diabetes education programme

OBJECTIVES: To determine the cost and benefits of an intensive diabetes education programme for patients with prolonged self-management problems and to determine the inclusion criteria for optimal outcomes. METHODS: Sixty-one participants of a multidisciplinary intensive diabetes education programme (MIDEP) were measured before they started the intervention (T0), and at 1-year follow-up (T1). Data on glycaemic control (HbA1c), diabetes-related distress (PAID) and costs were obtained. Changes over time were analysed and means at T0 and T1 were compared to a reference group of 230 non-referred consecutive outpatients. The number needed to treat (NNT), that is, the number of patients to be treated to achieve one successful case, was calculated for different baseline values of HbA1c and PAID to determine optimal inclusion criteria. RESULTS: Diabetes-related costs decreased significantly and participants improved significantly in HbA1c and diabetes-related distress following MIDEP. HbA1c and distress reached the levels of the reference group. The T1 costs remained higher than in the reference group, but the reduction in costs outweighed the intervention costs. Including patients with baseline HbA1c>or=8.0% and/or PAID scores>or=40 would improve the NNT to achieve clinically relevant outcomes, while 76% of the patients matched these inclusion criteria. CONCLUSIONS: MIDEP is effective in improving glycaemic control and diabetes-related distress for patients with prolonged self-management difficulties. Besides the immediate reduction in costs found in the present study, improved glycaemic control may reduce future costs of diabetic complications. Stricter inclusion criteria with respect to HbA1c and PAID scores may further improve the programme's efficiency.     

Rapid and slow rate of decrease in HbA1a + b and HbA1c during improved glycaemic control

The change in glycosylated haemoglobins was studied with a column chromatographic method when glycaemic control was rapidly improved in nine diabetic patients. The patients were followed for 3 weeks or more. There was a decrease in HbA1a+b and HbA1c within the first few days of improved control and this decrease was faster than later on. The initial decrease of HbA1a+b was faster than that of HbA1c. In individual patients the initial decrease in glycosylated haemoglobins correlated with the initial rate of decrease in blood glucose. It is concluded that HbA1a+b and HbA1c decrease biphasically during improved glycaemic control. The rapid initial decrease may be due to labile HbA1 and it is large enough to influence the value of HbA1 as an indicator of long-term glycaemic control in some patients.     

Adherence to insulin and its association with glycaemic control in patients with type 2 diabetes

BACKGROUND: Good glycaemic control improves outcomes in patients with type 2 diabetes, but the extent to which this depends on adherence to insulin treatment is uncertain. AIM: To investigate the association between adherence to insulin and glycaemic control in insulin-treated patients with type 2 diabetes. DESIGN: Observational records-based study. METHODS: We studied all patients with type 2 diabetes who were resident in Tayside, Scotland from 1 January 1995 to 30 September 2001, and who were treated with insulin. Adherence to insulin treatment was measured as the annual number of days of insulin coverage on the recommended dose, calculated from the amount of drug dispensed at community pharmacies and the recommended dose level for each patient. The association between glycaemic control (HbA1c), and adherence was determined, as was the influence of covariates, including age, sex, duration of diabetes and number of injections per day. RESULTS: A total of 1099 people were studied: 574 (52%) males and 525 (48%) females, mean +/- SD age 62 +/- 12 years, diabetes duration 10 +/- 7 years. Median time in the study (time for which insulin was dispensed) was 1107 (range 366-2446) days. Insulin prescribed was 58.0 +/- 33.3 IU/day and insulin collected from pharmacies was 53.6 +/- 27.1 IU/day. Mean adherence to insulin was thus 70.6%+/-17.7%. Adherence to insulin (p = 0.0021), BMI (p = 0.0001) and diabetes duration (p = 0.0314) were all significant predictors of HbA1c. DISCUSSION: Adherence to insulin appears poor in these type 2 diabetes patients, and there was a significant relationship between adherence and long-term metabolic control.     

Combined insulin-glibenclamide therapy of NIDDM patients in primary health care. A follow-up study of its compliance and efficacy and a review of the literature

Twenty non-insulin-dependent diabetic (NIDDM) patients with secondary failure to sulphonylureas were given combined insulin-glibenclamide therapy. After discharge they were followed for the following 12 months at different primary care centres. In the 19 patients who completed the combined therapy, the mean glycosylated haemoglobin A1c (HbA1c) level decreased from 11.2 +/- 0.5% to 9.1 +/- 0.3% at 2 months (p less than 0.001), and remained at 9.1 +/- 0.4% at 12 months. The reduction of HbA1c was positively correlated with the HbA1c value and inversely with the initial body weight (both p less than 0.05). There was a slight rise in the body mass index (BMI) from 26.9 +/- 0.9 to 28.2 +/- 0.7 at 12 months (p less than 0.001), which was inversely correlated with the BMI value at 0 month (p less than 0.05). The insulin doses were similar at 2 and 12 months. A review of the literature since 1985 identified ten double-blind, controlled studies on combined insulin-sulphonylurea therapy, comprising 156 NIDDM patients followed for 8-52 weeks. Improved glycaemic control and endogenous insulin secretion were documented in nine of these studies in parallel with a decrease of insulin requirement in six studies. We conclude from our own experience and the literature that combined insulin-glibenclamide therapy is an efficient and compliant therapeutic regimen.     

IFCC standardised HbA1c: should the world be as one?

Abstract The central importance of HbA1c in monitoring glycaemic control was highlighted by the Diabetes Control and Complications Trial (DCCT) which showed that improved glycaemic control, as monitored by HbA1c, delayed the onset of diabetic complications. Following this publication the issue of international standardisation of glycated haemoglobin (GHb) measurements became an important objective. The lack of international standardisation resulted in several countries developing National Standardisation Programmes. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on HbA1cStandardisation has established a reference measurement procedure (HPLC-MS or HPLC-CE) for HbA1c embracing the concept of metrological traceability. The reference method is anchored to a global network of 15 approved reference laboratories; this confers sustainability and a low level of uncertainty. Essential elements of a comprehensive reference measurement system additionally include the definition of the measurand and the unit of measurement. HbA1c is defined as haemoglobin (Hb) molecules having a stable adduct of glucose to the N-terminal valine of the β chain [Hb β chain (Blood) - N-(1-deoxyfructos-1-yl) Hb β chain] and that mmol/mol be used as the unit of measurement. These developments will result in improvements in inter-method and inter-laboratory agreement. Additionally, global acceptance of standardisation based on metrologically sound principles will enable clinical goals and diagnostic guidelines to be developed that can be adopted by all countries.     

Factors affecting the efficacy of starting insulin treatment in Type 2 diabetic patients. A retrospective evaluation

OBJECTIVE: To assess the efficacy and practices of insulin treatment in Type 2 diabetes mellitus in primary health care. SETTING: Primary health care in southwest Finland (population 250,000). DESIGN: Cases in the target area with insulin treatment initiated in 1991-1997 were identified and the patient records were analysed retrospectively for up to 5 years from treatment. PATIENTS: A total of 883 patients with Type 2 diabetes (aged 40-91 years) were identified. MAIN OUTCOME MEASURES: HbA1c and body weight. RESULTS: HbA1c declined by 2.0 percentage points from 10.0% to 8.0% (p < 0.001) at 12 months from the initiation of insulin, irrespective of age. The decrease was smaller in obese patients (BMI > 34 kg/m2). A slightly better glycaemic control was achieved when the treatment was initiated by a specialist rather than by a general practitioner. The improvement in HbA1c was essentially unchanged at 4 years. The decrease in HbA1c was largely independent of the type of the insulin regimen (insulin alone, combined insulin and oral therapy). The daily insulin dose increased markedly and the proportion of patients on combination therapy decreased from 57% to 38% at 4 years. The mean body weight of the patients increased (3.7 kg at 12 months, 5.7 kg at 4 years). The weight increase was highest in patients treated with insulin alone. CONCLUSIONS: Introducing insulin therapy in poorly controlled Type 2 diabetic patients results in a marked decrease in HbA1c. Insulin therapy can be initiated in all age groups with equal results. Insulin treatment can be initiated and improved metabolic control maintained in primary health care.     

血清肿瘤坏死因子α水平与2型糖尿病肾病的相关性及应用价值分析

目的探讨血清肿瘤坏死因子α(TNF-α)水平与糖尿病肾病指标的相关性及其临床应用价值。方法纳入2型糖尿病(T2DM)患者200例,其中未合并糖尿病肾病者100例为DM组,T2DM肾病患者100例为糖尿病肾病组,同期健康人50例为对照组。比较三组体重指数(BMI)、空腹血糖(FBG)、餐后2小时血糖(2 hPBG)、糖化血红蛋白(HbA1c)、血尿素氮(BUN)、肌酐(SCr)、总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白(HDL-C)、低密度脂蛋白(LDL-C)、TNF-α等指标,并分析糖尿病肾病的危险因素,以及血清TNF-α水平与不同参数的相关性,分析TNF-α在DM、糖尿病肾病中的诊断效能。结果DM、糖尿病肾病组患者的BMI、FBS、2 hPBG、BUN、SCr、TG、TC、HDL-C、LDL-C、HbA1c、TNF-α等指标与对照组比较,差异均有统计学意义(P<0.05);Logistic回归显示病程、BUN、SCr、TG、TC、HDL-C、LDL-C、HbA1c、TNF-α为糖尿病肾病的独立危险因素(P<0.05);糖尿病肾病患者血清FBS、Cr、TC、LDL-C、HbA1c、ACR与血清TNF-α水平呈正相关(P<0.05);利用血清TNF-α在诊断DM、糖尿病肾病及鉴别中均具有较高的效能,其AUC值分别为0.875、0.966及0.835。结论血清TNF-α水平在诊断、鉴别DM、糖尿病肾病中具有较好的诊断效能,同时在评估糖尿病肾病严重程度中具有较高的应用价值。