Cost of severe hypoglycaemia in patients with type 1 diabetes in Spain and the cost-effectiveness of insulin lispro compared with regular human insulin in preventing severe hypoglycaemia.

OBJECTIVES: To determine the costs of severe hypoglycaemia (SH) in a population of patients with type 1 diabetes mellitus in the Spanish healthcare system and the cost-effectiveness of insulin lispro over regular insulin in preventing SH episodes. METHODS: A retrospective study of 100 patients in three Spanish health centres was performed. Resource utilisation data were collected only for interventions specifically relating to the hypoglycaemic episode. The direct medical costs determined in the analyses were: costs of hospitalisation, diagnostic tests carried out, costs of treatment administered and other associated costs such as visits to the endocrinologist and re-training in glucose control, transportation and assistance of a care-giver. In addition, indirect costs such as days of lost productivity were measured. The incidence rates of SH for insulin lispro and regular insulin were obtained from the literature. The incremental cost-effectiveness of insulin lispro over regular insulin was calculated. RESULTS: The overall mean cost per episode of SH was 366 euro, comprised of 65.4% direct costs and 35.6% indirect costs. The largest cost was for hospitalisation at 183 euro per episode. The SH episodes incidence rates for 100 patients per year were 33 and 73 for insulin lispro and 48 (p < 0.05) and 117 (p < 0.01) for regular insulin, in the two clinical trials found in the literature. The additional cost to prevent one episode of SH with insulin lispro over regular insulin ranged from 277 euro to insulin lispro dominance. CONCLUSIONS: Severe hypoglycaemia has a significant impact on the total cost of diabetes. The use of insulin lispro is associated with reductions in annual costs because of SH and, possibly, the overall effect may be cost neutral or cost saving when total costs are considered. The cost of SH should be included in the analysis of total socio-economic burden of diabetes.

Comparison of peripheral arterial reconstruction in diabetic and non-diabetic patients: a prospective clinic-based study.

UNLABELLED: To assess the efficacy and safety of lower extremity arterial reconstruction in diabetic and non-diabetic subjects during a 3-year period. A prospective clinic-based study between 1994-1999 in Area 7, Madrid, with a population of 569307 and an estimated diabetic population of 37932 (15505 men and 22427 women). The level of arterial reconstruction and associated risk factors were ascertained. RESULTS: A total of 588 peripheral revascularization surgical procedures were performed in 481 patients. The diabetic patients (n=174, 36.2%) underwent 222 surgical procedures (including 48 follow-on operations, 21.6%), and 307 non-diabetic subjects underwent 366 surgical procedures (59 follow-on operations, 16.1%). The numbers of surgical procedures per 100000 people at risk and year were 18.8 and 1.8 for non-diabetic men and women, respectively, and 145.1 and 29.0 for men and women with diabetes mellitus (7.7- and 16.2-fold, respectively). Age at reconstruction surgery was 2 and 5 years earlier in non-diabetic than in diabetic men and women, respectively. Diabetic patients had a higher neuropathy score (P<0.05) and were less frequently smokers (P<0.05) than non-diabetic subjects. Diabetic subjects more frequently had distal reconstruction while proximal arterial reconstruction was more often performed in non-diabetic subjects. Between 64.6 and 80.4% of people with diabetes and 82.3 and 88.9% of non-diabetic subjects had no complications during their in-hospital stay. Distal amputation simultaneous to arterial reconstruction was the most frequent morbidity of people with diabetes during the study (P<0.05). Despite a graft occlusion rate after femoropopliteal revascularization significantly higher than in non-diabetic people (P<0.05), diabetic people more often required lower extremity amputations (LEAs) for the same level of bypass (P<0.01). Cumulative limb salvage rates were lower in diabetic patients than in non-diabetic subjects at femoropopliteal (49.2 vs. 89.7%; P<0.001), femorodistal (73.5 vs. 95.2%; P<0.01), and distal reverse (77.9 vs. 87.3%; P<0.05) arterial reconstruction, at the end of the third year, but similar after aorto-iliac reconstruction (93.1 vs. 97.5%). A higher neuropathy score and the presence of foot ulcers were associated to significantly lower limb salvage in diabetic patients (P<0.05), but not in non-diabetic people. Survival rates after 3 years were similar between diabetic and non-diabetic populations after aorto-iliac (93.1 vs. 97.5%), femoropopliteal (97.2 vs. 90.3%), and distal reverse (93.2 vs. 98.1%) revascularization, and slightly lower in diabetic compared to non-diabetic patients after femorodistal revascularization (82.1 vs. 96.3%; P<0.05). CONCLUSION: Although limb salvage after arterial reconstruction is lower in diabetic than in non-diabetic subjects, particularly in those with a higher neuropathy score, this surgical approach can be applied in both diabetic and non-diabetic subjects with otherwise similar outcome.

Nontraumatic lower extremity amputations in diabetic and non-diabetic subjects in Madrid, Spain.

The purpose of this study was to determine the incidence of non-traumatic lower extremity amputations (LEAs) in diabetic and non-diabetic subjects in Madrid, Spain, and their direct cost. All patients who underwent LEAs between the 1st of January 1994 and the 31st of December 1996, and who had lived in area 7 of the city (569,307 inhabitants) for at least the last 6 months, were identified through operating theatre records cross-checked with Vascular Surgery Department discharge records. In addition, the direct cost of LEAs per year was estimated, taking into account the length of the hospital stay, the period of rehabilitation in the outpatient clinic after discharge, and the use of artificial limbs and their maintenance. The incidence of LEAs was 1.6 (95% CI: 1.1-2.2) per 10(5) non-diabetic subjects and 46.1 (95% CI: 34.5-57.6) per 10(5) diabetic patients. Relative risk was 28. Total direct costs associated with LEAs per year were US$ 56,131 in the diabetic population and US$ 30,765 in the non-diabetic population. Thus, potential cost savings associated with excess amputations in the diabetic population was estimated at US$ 541,353 per year of US$ 94,736 per 10(5) inhabitants. It is concluded that the incidence of LEAs in both diabetic and non-diabetic populations in area 7 is the lowest reported in European countries. The potential cost savings per 10(5) inhabitants and per year is estimated at US$ 94,736.

Changes in nutritional pattern, insulin sensitivity and glucose tolerance during weight loss in obese patients from a Mediterranean area.

In order to study the nutritional pattern in obese subjects living in an area with a Mediterranean diet, as well as the modifications in nutritional behaviour, cardiovascular risk factors and insulin sensitivity induced by changes in nutritional pattern, 54 obese patients completed a 20-week behaviour programme. They prospectively fulfilled a food records diary in order to ascertain their nutritional pattern. Weight, body mass index (BMI). waist-to-hip ratio (WHR), blood pressure (BP), cholesterol, HDL-c, LDL-c, triglycerides, fasting and 2 h-post glucose load plasma glucose were determined at the onset and at the end of the study. Insulin sensitivity index (SI), and glucose effectiveness (Sg) were assessed by using the modified FSIVGTT. The usual diet in obese patients living in a Mediterranean country is low in carbohydrates (35%) and high in fats (43%), 55% of the latter being monounsaturated fatty acids (MUFAs), especially olive oil. After the educational programme they decreased the caloric intake to slightly over 700 Kcal/day, with a reduction of 36% in carbohydrates consumption, 18% in proteins and 43% in fats (46% in MUFAs). These modifications resulted in a decrease in weight, BMI, WHR, BP, and fasting and 2 h-post glucose load plasma glucose (all p < 0.05), whereas the lipoprotein profile did not change. In a similar way SI and Kg (glucose disappearance rate) increased, while fasting plasma insulin (FPI) decreased (p < 0.05) and Sg and I1+3 remained unaffected. Our results indicate that weight loss induced by caloric restriction improves insulin sensitivity rather insulin secretory capacity or glucose effectiveness, and all the cardiovascular risk factors but lipoproteic profile, that remains unchanged, probably because of the lower MUFAs consumption. These facts should be taken into account when recommending changes in the diet of obese patients with a Mediterranean-style diet.

Comparison between acarbose, metformin, and insulin treatment in type 2 diabetic patients with secondary failure to sulfonylurea treatment.

The purpose of this study was to determine the most suitable treatment for Type 2 (non-insulin-dependent) diabetic patients with secondary failure to sulfonylureas (SFS). In a four-month comparative study, 36 Type 2 diabetic patients given SFS were allocated to three treatment groups: A (n = 12, M/F 6/6, HbAlc 9.1 +/- 1.6%) received 0.3 IU/Kg body weight (BW) of insulin-Zn between 10 and 11 p.m.; B (n = 12, M/F 6/6, HbAlc 9.2 +/- 1.6%) SFS plus 850 mg/day of metformin; and C (n = 12, M/F 6/6, HbAlc 9.5 +/- 2.4%) SFS plus acarbose 3 x 100 mg daily. Modifications in HbAlc, BW, blood pressure (BP), lipoprotein profile and insulin sensitivity were evaluated. HbAlc decreased in the three groups (A: 17.9 +/- 13.5%; B: 18.2 +/- 4.5%; C: 7.6 +/- 16.8%; all p < 0.05; A and B vs C = p < 0.05). BW increased in group A and decreased in the other groups. BP decreased statistically in group B. HDL-cholesterol increased (1.26 +/- 0.46 vs 1.49 +/- 0.36 mmol/L; p < 0.05) and triglyceride levels decreased (1.68 +/- 0.85 vs 1.16 +/- 0.43 mmol/L; p < 0.05) in group A. There were no significant changes in the other studied parameters. We conclude that, for Type 2 diabetic patients given SFS, both insulin and metformin plus SFS provided better glycaemic control than acarbose plus SFS. Metformin combined with SFS offered further advantages for the control of BW and BP.

Pancreatic reserve and insulin dose in type 2 diabetic patients.

In order to determine whether there is any relationship between pancreatic reserve and the insulin dose required for achieving a good metabolic control in type 2 diabetic patients with secondary failure to oral hypoglycaemic agents, fasting and post-glucagon C-peptide were determined in thirty-nine type 2 diabetic patients with secondary failure to sulphonylureas and hyperglycaemia < 250 mg/dl who attended an outpatient clinic. M-value was calculated in patients performing self-monitoring of blood glucose. Otherwise, pre- and post-prandial glycaemias were measured bi-weekly as outpatients. HbA1c and fructosamine were assessed monthly. A patient was considered well controlled when he or she fulfilled all the requirements of the European NIDDM Policy Group and the insulin dose necessary for these goals was correlated to the pancreatic reserve. There were two drop-outs. Thirty-five out of the thirty-seven patients complied with the objectives in an average time of 3.14 +/- 1.93 months. At the beginning of the study mean HbA1c was 8.01 +/- 1.40% and fructosamine 343.81 +/- 59.05 micromol/l, whereas at the end of the study the values were 6.91 +/- 0.94% and 291.89 +/- 38.59 micromol/l, respectively (both p < 0.001). Body weight increased from 68.95 +/- 12.40 to 69.44 +/- 12.54 kg (n.s.), while hypoglycaemic events decreased from 1.70 +/- 2.37 to 0.88 +/- 1.33 events/week (p < 0.05). To attain all the objectives, 19.03 +/- 5.98 i.u. (0.28 +/- 0.08 i.u./kg) of insulin were required. Basal and post-glucagon C-peptide were 1.97 +/- 1.24 and 3.29 +/- 1.85 ng/ml, respectively, with an increase of 1.32 +/- 0.78 ng/ml. All these values inversely correlated with insulin dose, especially the increase during the test (r = -0.652 with i.u./kg and r = -0.599 with i.u., both p < 0.01). In conclusion, C-peptide test is a good indicator of the insulin dose required for achieving the aims of metabolic control in type 2 diabetic patients.

Effects of different proportions of carbohydrates, polysaccharides/monosaccharides, and different fibers on the metabolic control in diabetic rats.

Recent findings have suggested that diets with a high level of carbohydrates may impair the metabolic control of diabetes mellitus in humans. Moreover, other investigations have indicated that if the simple sugar content is increased in order to attain a proportion of polysaccharides/monosaccharides equal to 1, then neither the blood glucose nor the lipidic response show any change. We have studied the effect of increasing carbohydrates in the diet (59% v 82%), while maintaining cereal fiber levels constant (30%) and replacing cereal fiber in high carbohydrate diets by guar gum (30%) and lentil-derived leguminous fiber (30%) on the metabolic control of streptozotocin-induced diabetic rats. A study with different diets was performed for 3 weeks. An increase of carbohydrates in the diet produces an increase in the HbA1 concentration (1.9% v 3.9%, P less than 0.01) and in serum triglyceride levels (98.75 +/- 22.09 mg/dL v 144.50 +/- 3.52 mg/dL, P less than 0.05). Total cholesterol and HDL-cholesterol levels remained unchanged. The increase does not occur if the cereal fiber is replaced by lentil-derived leguminous fiber. In a second experiment, we substituted 50% of the complex carbohydrates in diets with 80% carbohydrates by glucose. Blood glucose, triglycerides, and HbA1 levels rose significantly in the four groups of rats that received diets containing 50% carbohydrates in glucose form. In addition, a test meal was carried out on day 19, consisting of 2.5 g of food/kg of wt. The maximum increase in blood glucose and the area below the glucose curve response was also significantly higher in the four groups of rats who received glucose in their diet.(ABSTRACT TRUNCATED AT 250 WORDS)

Food glycaemic index or meal glycaemic response?

We have studied the glycaemic response to 50 g of carbohydrate (CHO) within a standard meal in order to ascertain the usefulness of the glycaemic index of food high in CHO for planning the diabetic diet. Carbohydrate was given in the form of three kinds of food: rice, potatoes and lentils, each having a different glycaemic index. Four types of standard meals were prepared with different energy distributions. A1,2,3: 60 per cent CHO, 10 per cent protein, 30 per cent fat and 1.35 MJ (322 kcal); A4,5,6: 60 per cent CHO, 30 per cent protein, 10 per cent fat and 1.37 MJ (327 kcal); B1,2,3: 40 per cent CHO, 20 per cent protein, 40; per cent fat and 2.08 MJ (498 kcal); B4,5,6: 40 per cent CHO, 40 per cent protein, 20 per cent fat and 2.08 MJ (499 kcal). The increase in postprandial blood glucose levels at 30 min was lower when lentils were given than with rice or potatoes in all four types of energy distribution used (P less than 0.01). No differences were found at the other times studied. The slope from time 0 to maximal increase of glycaemia was lower with lentils in meals B1,2,3 (P less than 0.006) and B4,5,6 (P less than 0.007) but not in A1,2,3 or A4,5,6. Areas under the curve of the glycaemic responses elicited by the foods studied were similar with all four types of energy distribution used. These similar glycaemic responses were unexpected since the three foods used have different glycaemic indices.(ABSTRACT TRUNCATED AT 250 WORDS)