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Insulin detemir is associated with more predictable glycemic control and reduced risk of hypoglycemia than NPH insulin in patients with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart.

OBJECTIVE: Insulin detemir is a soluble basal insulin analog with a unique mechanism of protracted action designed to reduce the variability associated with conventional basal insulins. This trial compared the glycemic control, risk of hypoglycemia, and effect on body weight of insulin detemir and NPH insulin in patients with type 1 diabetes treated with rapid-acting insulin aspart at meals. RESEARCH DESIGN AND METHODS: This study was a 6-month multinational open parallel-group comparison conducted at 46 centers in five countries and included 448 patients with type 1 diabetes randomized 2:1 to insulin detemir or NPH insulin, respectively. RESULTS: After 6 months, comparable HbA(1c) levels were found between the two treatment groups. Fasting plasma glucose tended to be lower in patients treated with insulin detemir, but this difference was not statistically significant (-0.76 mmol/l, P = 0.097). Within-subject variation in self-measured fasting blood glucose was lower with insulin detemir than with NPH insulin (SD 3.37 vs. 3.78 mmol/l, P < 0.001). Risk of hypoglycemia was 22% lower with insulin detemir than with NPH insulin (P < 0.05) and 34% lower for nocturnal (2300-0600) hypoglycemia (P < 0.005). Nightly plasma glucose profiles were smoother and more stable with insulin detemir (P = 0.05). Body weight was significantly lower with insulin detemir at the end of the trial (P < 0.001). CONCLUSIONS: Treatment with insulin detemir resulted in more predictable glycemic control, with smoother plasma glucose profiles than NPH insulin and a significant reduction in the risk of hypoglycemia. The reduction in body weight with insulin detemir is a potential additional advantage. Regimens optimized for insulin detemir may be able to improve glycemic control beyond that possible with NPH insulin.

Adult↗

Weight gain associated with improved glycemic control in population-based sample of subjects with type I diabetes.

Previous studies have suggested that weight gain is an identifiable risk of efforts to lower blood glucose with intensive insulin therapy in type I (insulin-dependent) diabetic subjects. This study examined this relationship in a population-based sample of type I diabetic subjects participating in the Wisconsin Epidemiologic Study of Diabetic Retinopathy. Four hundred five adults (aged greater than or equal to 21 yr) with type I diabetes, who were diagnosed before age 30 yr, were studied from 1980 to 1982 and in a follow-up examination from 1984 to 1986. Weight gain over the 4-yr interval averaged 1.8 +/- 5.9 kg. Weight gain was significantly associated (r = -0.26, P less than 0.001) with improvements in glycosylated hemoglobin levels; the quartile of subjects with the greatest improvements in glycemic control gained 3.4 kg, whereas the quartile of subjects with the smallest improvements in glycemic control lost 0.6 kg. Weight gain was also correlated with increases in the number of shots of insulin per day and change in the treatment regimen from one type of insulin to a combination of short- and long-acting insulins. These results suggest that weight gain may be an adverse consequence of improved glycemic control. Efforts to better understand the mechanism explaining weight gain and to prevent weight gain are needed.

Adult↗

Successful islet transplantation: continued insulin reserve provides long-term glycemic control.

Clinical islet transplantation is gaining acceptance as a potential therapy, particularly for subjects who have labile diabetes or problems with hypoglycemic awareness. The risks of the procedure and long-term outcomes are still not fully known. We have performed 54 islet transplantation procedures on 30 subjects and have detailed follow-up in 17 consecutive Edmonton protocol-treated subjects who attained insulin independence after transplantation of adequate numbers of islets. Subjects were assessed pretransplant and followed prospectively posttransplant for immediate and long-term complications related to the procedure or immunosuppressive therapy. The 17 patients all became insulin independent after a minimum of 9,000 islets/kg were transplanted. Of 15 consecutive patients with at least 1 year of follow-up after the initial transplant, 12 (80%) were insulin independent at 1 year. In 14 subjects who have maintained demonstrable C-peptide secretion, glucose control has been stable and glycemic lability and problems with hypoglycemic reactions have been corrected. After 2 of the 54 procedures, some thrombosis was detected in the portal vein circulation. Five subjects had bleeding related to the percutaneous portal vein access procedures: three required transfusion alone, and in one subject, who had a partial thrombosis of the portal vein, an expanding intrahepatic and subscapular hemorrhage occurred while on anticoagulation, requiring transfusion and surgery. Elevated liver function test results were found in 46% of subjects but resolved in all. Complications related to the therapy have been hypercholesterolemia requiring statin therapy in 65%; a rise in creatinine in two patients, both of whom had preexisting renal disease; a rise in protein in four, all of whom had preexisting proteinuria; and antihypertensive therapy increased or started in 53%. Three of the 17 patients have required retinal laser photocoagulation. There have been no cases of posttransplant lymphoproliferative disorder or cytomegalovirus infection, and no deaths. The acute insulin response to arginine correlated better with transplanted islet mass than acute insulin response to glucose (AIR(g)) and area under the curve for insulin (AUC(i)), but the AIR(g) and AUC(i) were more closely related to glycemic control. The AUC(i) directly posttransplant was lower in those who eventually became C-peptide deficient. Our results, with a maximum follow-up of 34 months, indicate that prolonged insulin independence can be achieved after islet transplantation. There are some risks associated acutely with the procedure, and hypercholesterolemia and hypertension are treatable concerns on longer-term follow-up. All patients with persisting C-peptide secretion have had a resolution of both glycemic lability and problems with hypoglycemic reactions. Apart from the rise in serum creatinine in two subjects, no serious consequences of immunosuppressive therapy have been encountered. Islet transplantation is a reasonable option in those with severe problems with glycemic lability or hypoglycemia.

Adult↗

Predicting long-term glycemic control of post-educational type II diabetic patients by evaluating serum 1,5-anhydroglucitol levels.

1,5-Anhydroglucitol (1.5-AG) is known to closely reflect diabetic control within several days. The possibility of predicting long-term glycemic control after an educational hospitalization of type II diabetic patients was investigated by examining the relationship between changes in serum 1,5-AG levels after a short-term trial home stay following an educational program and long-term changes in glycosylated hemoglobin A1c (HbA1c) levels after discharge. After 22 patients with type II diabetes had successfully completed the educational hospitalization program, they returned as outpatients for 5 nights in a row. Changes in serum 1,5-AG levels were determined during this period. The HbA1c levels were then determined over a period of 3 months after discharge, and the relationship between changes in 1,5-AG and HbA1c levels was examined. Changes in serum 1,5-AG levels during the 5-day trial home stay and the changes in HbA1c levels during the 3 months after discharge from the hospital were found to be significantly correlated (r = 0.70, P < 0.01). A comparison of the decreased group, which exhibited a decrease in 1.5-AG levels of 5.0 mumol/l or more during the trial home stay, and the unchanged group, revealed that increases in body mass index 3 months after discharge were significantly higher in the decreased group (1.2 +/- 0.4%) than in the unchanged group (0.2 +/- 0.5%) (P < 0.05). Determination of serum 1,5-AG levels of patients with type II diabetes before and after a trial home stay following educational hospitalization was found to be useful in identifying patients at high risk of recurrence of poor glycemic control in the future.

Aged↗

Glycemic control and development of retinopathy in youth-onset insulin-dependent diabetes mellitus. Results of a 12-year longitudinal study.

BACKGROUND: In 1979, the authors began a prospective study of the natural history of retinopathy in youth-onset insulin-dependent diabetes mellitus (IDDM). Their major goal was to determine if there was an association between glycemic control and the development and progression of retinopathy. METHODS: The study consisted of 420 individuals with IDDM (onset younger than 20 years of age) and no retinopathy at baseline. Study subjects were enrolled between 1979 and 1988. Stereo color fundus photographs were obtained annually. Two eye endpoints were recorded: duration when retinopathy was first detected, and when proliferative retinopathy was detected. Glycemic control was assessed by quarterly determinations of glycohemoglobin (GHb). Life-table analyses were performed relating duration of diabetes, sex, GHb, and age of diabetes onset to development of retinopathy. RESULTS: Retinopathy did not develop before 2 years' duration or before puberty. The prevalence of retinopathy was 50% by 9 years' duration and 100% by 20 years' duration. Retinopathy developed in females approximately 2 years sooner than in males, but plotting duration as postpubertal years resulted in nearly identical rates. Retinopathy developed significantly earlier in subjects with prepubertal onset of diabetes than in subjects with postpubertal onset if duration was plotted as postpubertal years. When separated into three groups based on GHb levels (< 7.5%, 7.5%-9%, > 9%), retinopathy developed approximately 2 years later in subjects in the less than 7.5% GHb group than those in the higher GHb groups. Proliferative retinopathy developed in 11 subjects. Their mean GHb level was higher than the mean GHb for those without proliferative retinopathy (10.9 versus 8.6%; P < 0.01). The higher the level of GHb, the sooner proliferative changes were detected. CONCLUSION: Long-term glycemic control is significantly related to both development and progression of retinopathy. Prepubertal duration of diabetes is a significant risk factor for the development of retinopathy.

Adolescent↗

Effect of conventional and intensified insulin therapy on free-insulin profiles and glycemic control in NIDDM.

OBJECTIVE: To investigate the effects on 24-h insulin and glucose profiles of two- and four-dose insulin regimens in patients with non-insulin-dependent diabetes mellitus (NIDDM) who have failed oral agent therapy. RESEARCH DESIGN AND METHODS: Ten patients with NIDDM and 10 matched nondiabetic control subjects took part in the study, a randomized crossover trial with 8-wk treatment periods. We determined 24-h profiles of blood glucose and free insulin in control subjects and patients when they were taking oral agents and at the end of each treatment period. The two-dose regimen was mixed (15% regular, 85% NPH) insulin given before breakfast and dinner, and the four-dose regimen was regular insulin given before meals and NPH given at 2200. RESULTS: Patients taking oral agents had higher mean blood glucose than control subjects (mean +/- SE 12.6 +/- 0.6 vs. 4.5 +/- 0.1 mM, P less than 0.0001) and similar 24-h insulin concentrations but lower postprandial insulin concentrations (at breakfast, 87.6 +/- 13.8 vs. 228.6 +/- 29.4 pM, P less than 0.01). Mean 24-h insulin concentrations were the same on two- and four-dose regimens, and both regimens caused basal hyperinsulinemia. Glycemic control also improved. Postprandial insulin peaks were higher at lunch and dinner on the four-dose regimen, and postprandial blood glucose was lower. Fasting proinsulin was elevated in patients compared with the control subjects (25.1 +/- 4.7 pM vs. 5.0 +/- 0.9 pM, P less than 0.001) and was suppressed to normal during insulin treatment. CONCLUSIONS: Two- and four-dose insulin regimens can achieve similar glycemic control. Both regimens cause basal hyperinsulinemia but normalize the hyperproinsulinemia observed during failure of oral agent therapy. Four-dose insulin regimens offer few advantages to the glycemic control achieved with two-dose regimens but may be more physiological.

Blood Glucose↗

Glycemic control and outcome of diabetic patients after successful percutaneous coronary revascularization.

OBJECTIVE: Our purpose was to examine whether the outcome of diabetic patients after successful percutaneous coronary revascularization (PCR) is influenced by the degree of control of hyperglycemia at the time of revascularization. BACKGROUND: Diabetic patients have a worse outcome after PCR. METHODS: We examined whether the degree of glycemic control (HbA(1c) levels) affected the occurrence of all-cause death and death/myocardial infarction among diabetic patients after successful PCR from October 1979 through December 1998. HbA(1c) was analyzed both as a continuous and a categorical variable (good [HbA(1c) <8.0%, n = 700], moderate [8.0% < or = HbA(1c) < or =10%, n = 442], or poor [HbA(1c) >10%, n = 231] control). RESULTS: HbA(1c) levels were determined at a median (25th, 75th interquartiles) of 3 (1, 10) days after the index procedure for patients with good control, 2 (1, 7) days for moderate control, and 2 (1, 6) days for poor control. Median follow-up after successful PCR was 3.2 (1.2, 6.1) years, 3.9 (1.7,6.3) years, and 4.7 (2.1, 7.1) years, respectively. HbA(1c) as a continuous variable did not have an impact on either death (hazard ratio [95% confidence interval] 1.04 [0.98-1.10]) or death/myocardial infarction (1.02 [0.98-1.07]). As a categorical variable, patients with moderate and poor control had a similar hazard of death (0.99 [0.78-1.26] and 1. 14 [0.86-1.52], respectively) and death/myocardial infarction (1.01 [0.82-1.24] and 1.12 [0.87-1.45], respectively) relative to those with good control. CONCLUSIONS: The degree of glycemic control among diabetic patients at the time of their index intervention did not have an impact on long-term outcomes after successful PCR.

Aged↗

The role of intensive glycemic control in the management of patients who have acute myocardial infarction.

Hyperglycemia is associated with excess mortality in AMI and should be treated aggressively in the intensive care setting. The exact goal of therapy is unclear because different blood glucose targets were used in earlier studies (eg, 215 mg/dL in DIGAMI versus 110 mg/dL in the Belgian study of critically-ill patients). In the setting of AMI, it is prudent to avoid excessive hypoglycemia and, thus, more modest goals for blood glucose may be considered until more definitive data are present. Aggressive therapy with continuous infusion of insulin seems to improve a host of metabolic and physiologic effects that are associated with acute hyperglycemia and improves mortality in the acute setting. Aggressive glycemic control should be coupled with appropriate use of reperfusion therapies, glycoprotein IIb/IIa inhibitors, aspirin, 1-blockers, ACE inhibitors, and antithrombotic agents. The role of intensive chronic glucose control in reducing CV events is less clear but earlier studies were not well-powered; did not achieve aggressive, durable glycemic control; and did not use insulin-sensitizing agents routinely. Given the results of the DIGAMI trial, the goal of therapy postdischarge should include strict glycemic control while future studies help to delineate the role of insulin-sensitizing agents versus insulin-providing agents in reducing recurrent macrovascular events. Careful attention also should be paid to aggressive lifestyle modifications and treatment of hypertension, hyperlipidemia, and left ventricular dysfunction, as well as appropriate use of anti-platelet and antithrombotic agents.

Diabetic Angiopathies↗

Comparison of glycated albumin (GA) and glycated hemoglobin (HbA1c) in type 2 diabetic patients: usefulness of GA for evaluation of short-term changes in glycemic control.

We studied the cross-sectional relationship between GA and HbA1c in 142 type 2 diabetic patients who had an HbA1c level < 7.5% for at least one year without fluctuation by more than 0.5%. We also followed the changes of GA and HbA1c in 18 type 2 diabetic patients for 16 weeks as they progressed from untreated severe hyperglycemia (HbA1c > or = 9.0%) to good glycemic control (HbA1c < or = 6.5%) by intensive insulin treatment. The annual mean levels of GA and HbA1c in the stably controlled patients showed a weak, but significant, correlation (r = 0.23, p<0.001) in the 142 diabetic patients. However, the GA/HbA1c ratio ranged widely from 2.0 to 4.0 showing a normal distribution (2.9 +/- 0.34, M +/- SE), although patients with conditions affecting albumin turnover or RBC lifespan were excluded from the study. The GA/HbA1c ratio was significantly higher when patients were in hyperglycemic than when glycemic control was good (3.5 +/- 0.15 vs. 2.9 +/- 0.07, M +/- SE, p<0.01). GA decreased more rapidly than HbA1c during intensive insulin therapy, but the percent reduction of HbA1c eventually corresponded with that of GA by 16 weeks after the start of treatment. These results demonstrate that, although unknown influences on GA or HbA1c may exist, GA may be a useful marker for monitoring short-term variations of glycemic control during treatment of diabetic patients.

Aged↗

Comparison of fructosamine with glycosylated hemoglobin and plasma proteins as measures of glycemic control.

The relative value of fructosamine as an alternative to glycosylated hemoglobin (HbA1) and other measures of glycemic control was assessed in 100 insulin-dependent (IDDM) and 104 non-insulin-dependent (NIDDM) diabetic patients. We measured HbA1 (by electrophoretic and affinity methods), plasma glucose, glycosylated plasma proteins, and fructosamine in blood taken at a single clinic visit. The values were compared both by correlation analysis and by considering whether the various indices of glycemic control placed the patients in the same clinical decision categories as they were in by the HbA1 (affinity) result. Fructosamine correlated moderately well with HbA1 (affinity; r = .8) and placed 71% of IDDM and 72% of NIDDM patients in the same clinical category of good, moderate, or poor control. Differences can probably be partly attributed to the different periods over which HbA1 and fructosamine reflect average glycemia and partly to imprecision.

Adolescent↗

Personal models of diabetes in relation to self-care, well-being, and glycemic control. A prospective study in adolescence.

OBJECTIVE: Personal models of diabetes have been shown to be proximal determinants of self-care behavior in adults with diabetes, both cross-sectionally and prospectively. This study set out to test the predictive utility of this approach in adolescents with diabetes. RESEARCH DESIGN AND METHODS: Participants were recruited from four regional hospitals in southern England (n = 54). They completed questionnaires assessing diabetes self-care, well-being, and personal models of diabetes (perceived impact, perceived seriousness, and short- and long-term treatment effectiveness) at baseline and 1-year follow-up. GHb assays performed as part of the patients' usual diabetes care were used to assess glycemic control. RESULTS: After controlling for baseline anxiety, change in perceived impact of diabetes prospectively predicted adolescents' anxiety (beta = -0.21; t = -2.65; P < 0.01). After controlling for baseline dietary self-care, change in perceived effectiveness of the diabetes treatment regimen to control diabetes predicted dietary self-care (beta = -0.39; t = -3.28; P < 0.0005). Poorer dietary self-care and being female were predictive of poorer glycemic control (r2 = 0.29; F = 2.74; P < 0.005). CONCLUSIONS: This study provides further support for the role of personal models of illness in determining responses to illness. As adolescents take responsibility for the management of their diabetes, parents, clinicians, educators, and interventionists should consider these adolescents' beliefs about their diabetes and its treatment as key factors influencing self-care, emotional well-being. and glycemic control.

Adolescent↗

Change in glycemic control predicts change in weight in adolescent boys with type 1 diabetes.

OBJECTIVE: To characterize the intraindividual relationships between changes in weight, glycosylated hemoglobin (HbA1c) levels, and reported total daily insulin dose between clinic visits in adolescent boys with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: Intraindividual changes in HbA1c, anthropometric data, and reported total daily insulin dose between consecutive visits for 94 adolescent boys with T1D were analyzed. RESULTS: Average quarterly weight gain was 2.8 kg during periods of improving, 1.5 kg during periods of minimal change, and 0.8 kg during periods of worsening glycemic control (improving vs. minimal change p < 0.001; minimal change vs. worsening p = 0.11; improving vs. worsening p < 0.001). Analyzing the quarterly weight velocity according to change in reported total daily dose of insulin, we found significantly greater weight gain during intervals when the family reported a decreasing insulin dose compared to intervals when the family reported no change in insulin dose (p = 0.003). Conversely, weight change during periods of reported increasing insulin dose was similar to that when the family reported that the boy's insulin dose did not change. CONCLUSIONS: Quarterly weight velocity was correlated with degree of change in glycemic control between visits in adolescent boys with T1D. When weight loss or inadequate weight gain and worsening glycemic control occur, the possibility of insulin omission must be explored. Reviewing the adolescent's growth data and then the division of responsibilities for diabetes management within the family, clinicians must reconcile discrepancies between weight velocity and a reportedly adequate dose of insulin.

Adolescent↗

Frequency and accuracy of self-monitoring of blood glucose in children: relationship to glycemic control.

We evaluated the long-term effects of self-monitoring of blood glucose (SMBG) on glycemic control in a large unselected group of insulin-dependent diabetic (IDD) children and adolescents (N = 282) treated at a diabetes clinic. Among those who had been taught SMBG techniques (N = 229) and reported frequency of use (N = 209), only 26% reported monitoring three or more times per day. HbA1 levels of patients who monitored their blood most frequently did not differ from those who monitored blood less frequently or those who monitored only urine. Likewise, HbA1 levels of patients who monitored with machines did not differ from Chemstrip bG users. Accuracy was assessed in a subsample of 100 randomly selected Chemstrip bG users by comparing their Chemstrip reading with a laboratory value. Fifty-eight percent of the readings were within 20% of the laboratory value. Accuracy did not relate to frequency of monitoring or to HbA1 levels. These data suggest that frequency and accuracy of SMBG are independent and that neither ensures good glycemic control.

Adolescent↗

Phobic symptoms, particularly the fear of blood and injury, are associated with poor glycemic control in type I diabetic adults.

OBJECTIVE: To investigate the presence of psychiatric disorders and symptoms in type I diabetic patients and to identify those that may influence metabolic control as assessed by GHb levels. RESEARCH DESIGN AND METHODS: This was a cross-sectional study. One hundred and two consecutive patients with type I diabetes who were regular outpatient visitors of a diabetology department were evaluated. The psychiatric assessments included self-rating questionnaires (General Health Questionnaire and Fear Questionnaire) and observer-rating questionnaires (Montgomery-Asberg Depression Rating Scale [MADRS] and Mini International Interview). Diabetic characteristics were assessed by a structured interview. The observer was blind to the diabetic characteristics of the patients. RESULTS: Type I diabetic patients with GHb levels > or = 8% had higher psychological distress, scored significantly higher for symptoms of agoraphobia and for fear of blood and injury, had substantially higher levels of anxiety-depression, and performed significantly fewer blood glucose measurements per day. They did not differ in MADRS score from patients with GHb levels < 8%. Multivariate analysis showed that GHb was positively associated with the total score of phobic symptoms and the level of anxiety-depression and inversely associated with the number of daily blood glucose measurements. These factors explained 41% of the variance of GHb. The inverse relationship between GHb and the number of blood glucose measurements per day was mainly influenced by the fear of blood and injury. Patients with high scores for the fear of blood and injury performed fewer blood glucose measurements and had poorer glycemic control; conversely, subjects without fear of blood and injury performed more daily blood glucose measurements and had better glycemic control. CONCLUSIONS: Phobic symptoms are frequent in patients with type I diabetes. The intensity of phobic symptoms and anxiety-depression negatively influences metabolic control. Increased fear of blood and injury may lead some patients to perform few home blood glucose measurements and may result in poorer glycemic control. This suggests that, by decreasing the fear of blood, injury, and injection, metabolic control may be improved.

Adolescent↗

Correlation between glycemic control and menstruation in diabetic adolescents.

OBJECTIVE: To determine if a correlation exists between the degree of glycemic control in insulin-dependent diabetic adolescents and menstrual regulation. STUDY DESIGN: A retrospective review of charts of diabetic girls aged 10-18 was performed. Office visits were scheduled every three to six months, at which time pubertal development, menstrual function, growth and diabetic control, including hemoglobin (Hgb) A1C, and complications were assessed. Forty-six patients were eligible for data analysis. Descriptive and inferential statistics, including chi 2 and Student t tests, were applied. RESULTS: Thirty-seven (81%) patients had regular menstrual cycles, and nine (19%) had menstrual disturbances, including secondary amenorrhea (one), oligomenorrhea (seven) and primary amenorrhea followed by oligomenorrhea (one). There were two pregnancies. Six patients used hormonal contraception but none for menstrual regulation. There was a statistically significant difference (P < .05) in mean Hgb A1C concentrations between those with menstrual disturbances (11.4) and those with regular menses (9.7). As Hgb A1C values increased, the percent of patients with menstrual disturbances increased, becoming statistically significant when the Hgb A1C was > 10 (odds ratio 7.3, 95% confidence interval 1.5-35.6). There was no difference (P > .05) between the two groups with respect to age at menarche (156 vs. 152 months), age at onset of diabetes (144 vs. 108 months) and interval between diabetes onset and menarche (54 vs. 41 months). There were no patients in either group with diabetic retinopathy or nephropathy. Four patients were hypertensive, but there was no statistically significant difference (P > .05) between groups. CONCLUSION: Tighter glycemic control, as measured by Hgb A1C concentrations, corresponded to improved menstrual regulation in adolescent insulin-dependent diabetics.

Adolescent↗

Diabetic peripheral neuropathy: effects of age, duration of diabetes, glycemic control, and vascular factors.

The aim of this study was to determine the factors associated with diabetic peripheral neuropathy and more particularly its relation to precisely assessed microangiopathy. Peripheral neuropathy was assessed in 135 diabetic patients: 28 insulin-dependent diabetes mellitus (IDDM), 85 non-insulin-dependent diabetes mellitus (NIDDM), and 22 insulin-treated NIDDM patients, on the basis of both clinical findings and extensive electrophysiological testing (four motor nerves and four sensory nerves, and right and left Hoffmann's reflex), using a total of 20 parameters. The percentage of women with severe clinical neuropathy was significantly higher than that of men, and the clinical neurological stage correlated significantly with age and duration of diabetes. According to multivariate analysis the clinical stage correlated only with gender and duration of diabetes. Several electrophysiological parameters were significantly more abnormal in women and correlated with age, type and duration of diabetes, and recent glycemic control. The multivariate analysis showed that 17 electrophysiological parameters correlated with duration of diabetes, nine correlated with age, seven with glycemic control, and only one with gender. The presence of clinical neuropathy also correlated with presence of retinopathy, arterial hypertension, macroangiopathy, and biological signs of nephropathy. All the electrophysiological parameters were significantly more abnormal in patients with retinopathy or macroangiopathy than in patients without these complications. Separate parameter analysis showed that at least one abnormal electrophysiological parameter was almost always found in patients with retinopathy, macroangiopathy, or incipient nephropathy, but abnormalities were also found to a slightly lesser extent in patients without these complications. Multivariate analysis showed that when duration of diabetes, retinopathy, macroangiopathy, and biological signs of nephropathy were introduced into the model, 11 electrophysiological parameters correlated with duration of diabetes, 11 with retinopathy, seven with macroangiopathy, and five with a sign of nephropathy. This study demonstrates that age and glycemic control have an effect, and diabetes duration a major effect on peripheral nerve function. It suggests that vascular factors may participate in the development of nerve lesions.

Adolescent↗

The feasibility of intensive insulin management in non-insulin-dependent diabetes mellitus. Implications of the Veterans Affairs Cooperative Study on Glycemic Control and Complications in NIDDM.

OBJECTIVE: To review the results from the Veterans Affairs Cooperative Study on Glycemic Control and Complications in NIDDM (VACSDM) and to discuss the implications of the results from this feasibility trial. DESIGN: A randomized clinical trial comprising 153 men with non-insulin-dependent diabetes mellitus (NIDDM) who remained hyperglycemic on usual pharmacologic therapy. Patients were randomized into two groups receiving either standard or intensive insulin therapy and were followed for 27 months. SETTING: Five Veterans Affairs medical centers. PATIENTS: 153 men with NIDDM, aged 40 to 69 years, who had hemoglobin A1c (HbA1c) levels of greater than 6.55% while receiving sulfonylurea or insulin therapy. INTERVENTION: Standard insulin therapy was one or two insulin injections daily. Intensive insulin therapy was done using a stepwise approach: 1) evening intermediate or long-acting insulin; 2) addition of daytime glipizide; 3) insulin twice daily, with no glipizide; and 4) insulin three to four times daily, with no glipizide. MEASUREMENTS: Fasting blood glucose and HbA1c levels, retinopathy, lipid and urinary albumin levels, cardiovascular events, hypoglycemia, and body mass index. RESULTS: In the intensive group, the HbA1c level fell 2.07 percentage points; the mean HbA1c level was 7.3% from 6 months onward. The standard group experienced little change. These changes occurred without significant weight gain and with a very low rate of severe hypoglycemia. Sixteen patients (20.5%) in the standard group and 24 patients (32%) in the intensive group had cardiovascular events (P = 0.1). CONCLUSIONS: It is feasible to achieve excellent glycemic control in men with NIDDM in whom standard pharmacologic therapy has failed. The benefit/risk ratio of intensive insulin management in this patient group is not established and has been made the subject of a long-term prospective clinical trial.

Adult↗

Effect of stress management training on glycemic control in patients with type 1 diabetes.

AIMS: In this study, the effect of stress management training on glycemic control has been investigated in type 1 diabetic patients. METHODS: The participants were 60 type 1 diabetic patients (aged 16-30). 30 Subjects attended in 3-month stress management training classes during which the prescribed insulin remained constant, but the remainder 30 ones did not. HbA1 from all patients were measured before and after the intervention. Besides, in order to assess the ways of coping, every patient completed a questionnaire and the scores were compared between two groups. RESULTS: Trained patients showed significantly improved ways of coping. HbA1 changed from 11.7+/-2.9 and 10.9+/-2.1 before training to 8.5+/-1.7 and 10.3+/-2.1 after intervention in trained and control groups respectively and the changes were significant in study group (P<0.001). In addition, the difference between means of HbA1 of two groups was statistically significant at the end of the study (P<0.001). CONCLUSIONS: Results show a clinically significant beneficial effect of stress management training on glycemic control among type 1 diabetic patient. It is recommended to consider this type of training as an addition to the treatment program in type 1 diabetic patient.

Adolescent↗