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Aims: To assess the acceptability of and satisfaction with near patient testing for glycated haemoglobin in primary care in patients and health professionals., Methods: A questionnaire survey and qualitative study were nested within a randomized controlled trial conducted in eight general practices in Leicester-shire, UK. Satisfaction with diabetes care was compared in the intervention group (near patient test) and in the control subjects (usual laboratory test), using the Diabetes Clinic Satisfaction Questionnaire. Semistructured interviews were conducted with a purposive sample of patients and healthcare professionals and analysed using thematic coding and framework charting., Results: Questionnaire data for 344 patients were analysed and interviews were conducted with 15 patients and 11 health professionals. Interviews indicated that the near patient test was highly acceptable to patients and staff and confirmed that there may be potential benefits such as time saving, reduced anxiety and impact on patient management and job satisfaction. However, both the survey and the interviews identified high pre-existing levels of satisfaction with diabetes care in both intervention and control group patients and survey results failed to confirm increased patient satisfaction as a result of rapid testing. Limited patient understanding of glycated haemoglobin testing was noted., Conclusions: We were unable to confirm actual rather than potential advantages of the near patient test. Widespread adoption in primary care cannot be recommended without further evidence of benefit.

Background: Tight glycaemic control in people with type 2 diabetes can lead to a reduction in microvascular and possibly macrovascular complications. The use of near-patient (rapid) testing offers a potential method to improve glycaemic control., Aim: To assess the effect and costs of rapid testing for glycated haemoglobin (HbA1c) in people with type 2 diabetes., Design of Study: Pragmatic open randomised controlled trial., Setting: Eight practices in Leicestershire, UK., Method: Patients were randomised to receive instant results for HbA1c or to routine care. The principal outcome measure was the proportion of patients with an HbA1c <7% at 12 months. We also assessed costs for the two groups., Results: Of the 681 patients recruited to the study 638 (94%) were included in the analysis. The mean age at baseline was 65.7 years (SD = 10.8 years) with a median (interquartile range) duration of diabetes of 4(1-8) years. The proportion of patients with HbA1c < 7% did not differ significantly between the intervention and control groups (37 versus 38%, odds ratio 0.95 [95% confidence interval = 0.69 to 1.31]) at 12 months follow up. The total cost for diabetes-related care was 390 UK pounds per patient for the control group and 370 UK pounds for the intervention group. This difference was not statistically significant., Conclusion: Near-patient testing for HbA1c alone does not lead to outcome or cost benefits in managing people with type 2 diabetes in primary care. Further research is required into the use of rapid testing as part of an optimised patient management model including arrangements for patient review and testing.

Objective: To evaluate the efficacy of the addition of insulin when maximal sulfonylurea therapy is inadequate in individuals with type 2 diabetes., Research Design and Methods: Glycemic control, hypoglycemia, and body weight were monitored over 6 years in 826 patients with newly diagnosed type 2 diabetes in 8 of 23 U.K. Prospective Diabetes Study (UKPDS) centers that used a modified protocol. Patients were randomly allocated to a conventional glucose control policy, primarily with diet (n = 242) or an intensive policy with insulin alone (n = 245), as in the main study. However, for patients randomized to an intensive policy with sulfonylurea (n = 339), insulin was added automatically if the fasting plasma glucose remained >108 mg/dl (6.0 mmol/l) despite maximal sulfonylurea doses., Results: Over 6 years, approximately 53% of patients allocated to treatment with sulfonylurea required additional insulin therapy. Median HbA(1c) in the sulfonylurea +/- insulin group was significantly lower (6.6%, interquartile range [IQR] 6.0-7.6) than in the group taking insulin alone (7.1%, IQR 6.2-8.0; P = 0.0066), and significantly more patients in the sulfonylurea +/- insulin group had an HbA(1c) <7% (47 vs. 35%, respectively; P = 0.011). Weight gain was similar in the intensive therapy groups, but major hypoglycemia occurred less frequently over all in the sulfonylurea (+/- insulin) group compared with the insulin alone group (1.6 vs. 3.2% per annum, respectively; P = 0.017)., Conclusions: Early addition of insulin when maximal sulfonylurea therapy is inadequate can significantly improve glycemic control without promoting increased hypoglycemia or weight gain.

Aims: Type 2 diabetes mellitus (DM) has a high prevalence in Asian subjects. A simple method of screening using self-testing for postprandial glycosuria achieved a good response rate and a sensitivity which compared favourably to more expensive and invasive methods in a semirural Caucasian population. We examined its effectiveness in Asian subjects., Methods: Caucasian and Indo-Asian subjects aged 35-70 years in two general practices in Leicester (n=9896 (6198=Asian subjects, 3698=Caucasian)) were screened. Those known to have diabetes were excluded. Subjects were asked to self-test for glycosuria 1 h after their main meal. Instruction and response cards were translated in Punjabi and Gujarati and sent to the Asian subjects, depending on age and surname., Results: Response rate was 34.4% in Asian subjects compared to 54.0% in Caucasian subjects. Prevalence of glycosuria was 8.2% in Asian subjects and 3.2% in Caucasian subjects. Two hundred and thirty-nine subjects recorded glycosuria and 202 (84.5% of the total, 86.9% of Asian subjects, 78.1% of Caucasian) attended for oral glucose tolerance test (OGTT). Sixty-three (31.2%) were found to have diabetes (46, 73% Asian), 29 (14.4%) impaired glucose tolerance (24, 82.8% Asian) and 110 (54.4%) normal glucose tolerance (82, 74.6% Asian). Thus 30% of Asian subjects and 34% of Caucasian subjects had diabetes on OGTT. The prevalence of diabetes in 35-70 years in the total population after screening was 5.6% (6.8% in Asian subjects, 3.6% in Caucasian) and in the screened population was 12.7% (17.9% in Asian subjects, 6.3% in Caucasian)., Conclusions: Screening for diabetes using this method, in terms of response rate, is not as effective in a large city setting, particularly in the Asian population. However, the yield of diabetes in the age group 35-64 years compares well to much more expensive and labour intensive approaches and its use in this population in a primary care setting is justified.

Aims: Previous studies have shown that in Caucasian subjects with Type 2 diabetes mellitus (DM), the sulphonylurea glibenclamide increased insulin secretion without causing an increase in 32/33 split proinsulin secretion. South Asian subjects with Type 2 DM are thought to be more insulin resistant and the effect of sulphonylureas may be different. We therefore investigated the effect of sulphonylurea therapy with gliclazide on beta-cell function in South Asian subjects with newly diagnosed Type 2 DM., Methods: Glucose, insulin, and intact and 32/33 split proinsulin were measured at diagnostic oral glucose tolerance test (OGTT). After 8-12 weeks on a conventional diet, subjects with a fasting glucose > 6 mmol/l (n = 16) were commenced on gliclazide., Results: At diagnosis, those requiring gliclazide were more hyperglycaemic but there was no difference in weight or fasting insulin concentration than in the diet group. Following diet, in the gliclazide group, weight fell (P < 0.04) with no change in fasting glucose concentration. Fasting intact proinsulin, insulin and 32/33 split proinsulin remained unchanged. After gliclazide therapy weight remained unchanged, but fasting glucose fell (P < 0.003). Fasting insulin and intact proinsulin remained unchanged but 32/33 split proinsulin fell (P < 0.05). Fasting insulin to glucose ratio significantly improved after gliclazide (P < 0.006)., Conclusions: In South Asian subjects treated with gliclazide the reduction in fasting glucose concentrations appears to be due to an improvement in insulin sensitivity as well as in beta-cell function.

Study Objective: Analyses of causes of mortality in people with diabetes using data form death certificates mentioning diabetes provide unreliable estimates of mortality. Under-recording of diabetes as a cause on death certificates has been widely reported, ranging from 15-60%. Using a population based register on people with diabetes and linking data from another source is a viable alternative. Data from the Office of Population Censuses and Surveys (OPCS) are the most acceptable mortality data available for such an exercise, as direct comparison with other published mortality rates is then possible., Design: A locally maintained population-based mortality register and all insulin-treated diabetes mellitus cases notified to the Leicestershire diabetes register (n = 4680) were linked using record linkage software developed in-house (Lynx). This software has been extensively used in a maintenance and update cycle designed to maximise accuracy and minimise duplication and false registration on the diabetes register. Deaths identified were initially coded locally to the International Classification of Diseases, 9th revision (ICD9), and later a linkage was performed to use official OPCS coding. Mortality data identified by the linkage was indirectly standardised using population data for Leicestershire for 1991. Standardised mortality ratios (SMR) were estimated, with 95% confidence intervals. Insulin dependent diabetes (IDDM) was defined as diabetes diagnosed before age 30 years with insulin therapy begun within one year of diagnosis. All other types were considered non-insulin dependent diabetes (NIDDM). Analyses were performed for the whole sample and then for the NIDDM subgroup. Results from these analyses were similar and therefore only whole group analyses are presented., Main Results: A total of 370 deaths were identified for the period of 1990-92 inclusive - 56% were in men and 44% in women, median age (range) 71 years (12-94). Approximately 90% of deaths were subjects with NIDDM. Diabetes was mentioned on 215 (58%) death certificates. The all causes SMRs were significantly raised for men and women for all ages less than 75 years. Ischaemic heart disease (ICD9) rubrics 410-414) accounted for 146 (40%) deaths - 41% of male and 38% of female deaths. Male and female SMRs were significantly raised for the age groups 45-64, 65-74, and 75-84 years. Cerebrovascular disease (ICD9 rubrics 430-438) accounted for 39 (10%) deaths and the SMR for women the external causes of death (ICD9 rubrics E800-E999) were also significantly raised overall and in age groups 15-44 and 45-64 years. This was not true for men, although numbers of deaths in this category were small for both men (4) and women (9)., Conclusion: Record linkage has been used successfully to link two local, population based registers. This has enabled an analysis of mortality in people with diabetes to be performed which overcomes the problems associated with using as a sample, death certificates where diabetes is mentioned. The mortality rates and SMRs estimated should more accurately reflect the true rates than would be possible using other methods. The persisting excess mortality identified for people with diabetes is of a similar magnitude and attributable to similar causes as has been reported elsewhere in population based studies.

Red cell membrane cholesterol, 1,6-diphenyl-1,3,5-hexatriene (DPH) and 1-[(4-trimethylammonium)phenyl]-6-phenyl-1,3,5-hexatriene (TMA-DPH) anisotropies and basal and calmodulin-stimulated calcium pump activities were compared in 16 normolipidaemic Type 2 (non-insulin-dependent) diabetic patients and 20 normolipidaemic control subjects using the Mann-Whitney U-test. Serum cholesterol, membrane cholesterol, and membrane DPH and TMA-DPH anisotropies were similar in the two groups but both basal and calmodulin-stimulated calcium pump activities were reduced in the diabetic group: basal activity (median (inter-quartile range), mumol mg-1 h-1) 1.66 (1.18-1.97) vs 2.09 (1.90-2.50), p < 0.005 and calmodulin-stimulated activity 4.19 (3.07-5.48) vs 5.53 (4.70-6.88), p < 0.006. Although there were no correlations between glycaemic control and membrane anisotropy and between glycaemic control and calcium pump activity, the reduction in calcium pump activity is most likely due to a direct effect of diabetes on the calcium pump protein itself.

The prevalence of diabetes mellitus in adults was determined within a specific area of Leicester City, containing 20,053 Asians and 18,068 White Caucasian over the age of 16 years in the 1981 census. Subjects who had ever had classical symptoms with a random venous plasma glucose greater than or equal to 11.1 mmol/l were taken as diabetic. Exact numbers were ascertained from an analysis of diabetic clinic records and specialist health visitor records. The latter have formed an important part of community care for diabetics in Leicester for the last 30 years, and patients are referred by hospital consultants and nursing staff, and by general practitioners. Diabetes was ascertained in 967 Asians and 1194 White Caucasians. Age-adjusted relative risk of diabetes (95% confidence interval) increased in Asians over 45 years of age and was 1.6 (1.3-1.8) and 2.7 (2.5-3.2) for those aged 45-64 years and over 65 years, respectively. Relative risk of NIDDM was significantly higher (approximately x 2) in Asians in all age-groups. Our study shows that in Asians the prevalence of diabetes rises above 45 years of age and that NIDDM occurs more frequently in adult Asians. The causes and long-term effects of this require further analysis.

20 patients with non insulin dependent diabetes mellitus (NIDDM), and within 20% of their ideal body weight were studied. They had failed to achieve adequate diabetic control following 3 months of dietary therapy. They were randomly allocated to insulin or sulphonylurea therapy for 3 months and then "crossed over" for the same period of time. Patients were maintained at euglycaemia (plasma glucose 4-7 mmol/l) for 24 hr using an open-loop intravenous insulin infusion, and then underwent a standard 75 gm oral glucose tolerance test (OGTT) following each mode of therapy. Mean glycosylated haemoglobin and preprandial blood glucose were 8.7% and 7.7 mmol/l respectively after sulphonylurea, and 7.8% (p less than 0.05) and 6.6 mmol/l (p less than 0.05) after insulin therapy. There was no significant difference in change in body weight. Following a 75 gm OGTT mean plasma insulin at 1/2 hr and 1 hr was 14.0 mu/l and 16.5 mu/l after sulphonylurea, and 23.4 mu/l (p less than 0.05) and 22.1 mu/l (p less than 0.05) after insulin therapy. Plasma C-peptide responses were also improved at 1/2, 1 and 1 1/2 hr after a period of insulin therapy being 0.61 nmol/l, 0.65 nmol/l and 0.59 nmol/l respectively. After sulphonylurea therapy comparable plasma C-peptide responses were 0.31, 0.41 and 0.37 nmol/l respectively (p less than 0.05). There was no significant difference in the total amount of intravenous insulin required for 24 hr euglycaemia. Our study shows that short term insulin therapy in patients with NIDDM who had failed on diet alone has advantages over sulphonylurea therapy in that it achieves better diabetic control and an improved B-cell response to glucose stimulation.(ABSTRACT TRUNCATED AT 250 WORDS)

To determine the effect of short term intensive insulin therapy in non-insulin-dependent diabetes mellitus (NIDDM) we studied 10 patients who had been on maximal doses of sulphonylurea therapy, with a glycosylated haemoglobin value persistently above the normal range. All patients were non-ketonuric, had negative islet cell antibodies, and had been on sulphonylureas for a mean duration of 5.6 yr. Patients were maintained at euglycaemia (plasma glucose 4-7 mmol/l) for 24 hr using an open-loop intravenous insulin regimen, and then underwent a standard 75 g oral glucose tolerance test (OGTT). This was repeated after 3 months of treatment with insulin. Mean fasting plasma glucose and glycosylated haemoglobin were 10.1 mmol/l and 12.2% respectively before, and 7.1 mmol/l (p less than 0.001) and 8.4% (p less than 0.001) after treatment. There was no significant change in body weight. Plasma insulin and C-peptide responses to 75 g OGTT did not change significantly, but the total amount of intravenously infused insulin required for 24-hr euglycaemia fell from a mean value of 138 u before treatment to 87 u (p less than 0.001) at the end of insulin therapy. Remission, with glycosylated haemoglobin in the normal range for more than 3 months after stopping insulin, was observed in 5 out of the 10 patients. All 5 who failed to achieve remission had markedly blunted maximal insulin responses of less than 10 mu/l on both OGTT's. Our study shows that insulin treatment in NIDDM appears to exercise a beneficial effect by lowering insulin resistance. We suggest that this may be of advantage early on in patients with NIDDM in preserving B-cell reserve.