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Showing papers in "Diabetes Care in 1995"


Journal ArticleDOI
TL;DR: High internal reliability and consistent pattern of correlational findings indicates that the PAID is tapping into relevant aspects of emotional distress and that its particular feature, the measurement of diabetes-related emotional distress, is uniquely associated with diabetes-relevant outcomes.
Abstract: OBJECTIVE To describe a new measure of psychosocial adjustment specific to diabetes, the Problem Areas in Diabetes Survey (PAID), and to present initial information on its reliability and validity. RESEARCH DESIGN AND METHODS Before their routine clinic appointments, 451 female patients with type I and type II diabetes, all of whom required insulin, completed a self-report survey. Included in the survey was the PAID, a 20-item questionnaire in which each item represents a unique area of diabetes-related psychosocial distress. Each item is rated on a six-point Likert scale, reflecting the degree to which the item is perceived as currently problematic. A total scale score, hypothesized to reflect the overall level of diabetes-related emotional distress, is computed by summing the total item responses. To examine the concurrent validity of the PAID, the survey also included a series of standardized questionnaires assessing psychosocial functioning (general emotional distress, fear of hypoglycemia, and disordered eating), attitudes toward diabetes, and self-care behaviors. All subjects were assessed for HbA 1 , within 30 days of survey completion and again ∼ 1–2 years later. Finally, long-term diabetic complications were determined through chart review. RESULTS Internal reliability of the PAID was high, with good item-to-total correlations. Approximately 60% of the subject sample reported at least one serious diabetes-related concern. As expected, the PAID was positively associated with relevant psychosocial measures of distress, including general emotional distress, disordered eating, and fear of hypoglycemia, short- and long-term diabetic complications, and HbA 1 , and negatively associated with reported self-care behaviors. The PAID accounted for ∼ 9% of the variance in HbA 1 . Diabetes-related emotional distress, as measured by the PAID, was found to be a unique contributor to adherence to self-care behaviors after adjustment for age, diabetes duration, and general emotional distress. In addition, the PAID was associated with HbA 1 even after adjustment for age, diabetes duration, general emotional distress, and adherence to self-care behaviors. CONCLUSIONS These findings suggest that the PAID, a brief, easy-to-administer instrument, may be valuable in assessing psychosocial adjustment to diabetes. In addition to high internal reliability, the consistent pattern of correlational findings indicates that the PAID is tapping into relevant aspects of emotional distress and that its particular feature, the measurement of diabetes-related emotional distress, is uniquely associated with diabetes-relevant outcomes. These data are also consistent with the hypothesis that diabetes-related emotional distress, separate from general emotional distress, is an independent and major contributor to poor adherence. Given that the study was limited to female patients using insulin, further examination of the clinical usefulness of the PAID will need to focus on more heterogeneous samples.

1,167 citations


Journal ArticleDOI
TL;DR: The purpose of this review is to summarize current knowledge about the tests used most widely in monitoring the glycemic status of people with diabetes, and it includes tests of urine glucose and ketones and tests of blood glucose and glycated proteins (hemoglobin and serum proteins).
Abstract: Monitoring of glycemic status, as performed by patients and health care providers, is considered a cornerstone of diabetes care. Results of monitoring are used to assess the efficacy of therapy and to make adjustments in diet, exercise, and medications in order to achieve the best possible blood glucose control. The purpose of this review is to summarize current knowledge about the tests used most widely in monitoring the glycemic status of people with diabetes. The review addresses both patient- and physician/laboratory-based testing, and it includes tests of urine glucose and ketones and tests of blood glucose and glycated proteins (hemoglobin and serum proteins). The major emphasis is on the advantages and limitations of each test for routine clinical practice. Use of these tests for diabetes screening and diagnosis will not be addressed in this review. Since this review was first published in 1995, there have been many advances in the field, most notably standardization of glycated hemoglobin testing and new approaches to self-monitoring of blood glucose (SMBG), including minimally invasive continuous glucose monitoring over hours to days at a time. These and other advances are presented in detail in a recent report that was prepared by the National Academy of Clinical Biochemistry (NACB) and published as an American Diabetes Association (ADA) position statement (1). This review will attempt to complement, rather than duplicate, the material in the NACB report. If there was an ideal method of monitoring glycemic status, it might be a small noninvasive device, perhaps similar to a wristwatch that people with diabetes could wear to continuously monitor their blood glucose level. The device would warn of impending hypoglycemia. It also would store blood glucose data and perform a variety of calculations such as hourly, daily, weekly, or monthly blood glucose averages. Unfortunately, such a monitoring device is …

1,125 citations


Journal ArticleDOI
TL;DR: There is a need to understand the relation of hyperglycemia to pathogenetic mechanisms that lead to the development of specific complications, to develop new methods to detect and physiologically treat hyperglyCEmia, and to develop better methods of primary and secondary prevention of diabetic complications in people with IDDM and NIDDM.
Abstract: In summary, over the past 16 years, since the publication of Kelly West's book, epidemiological study has provided better insight into the relation of hyperglycemia and diabetic complications. Data from the WESDR demonstrate a strong consistent relationship between hyperglycemia and the incidence and progression of microvascular (diabetic retinopathy, loss of vision, and nephropathy) and macrovascular (amputation and cardiovascular disease mortality) complications in people with IDDM and NIDDM (Figs. 19 and 20). The DCCT has demonstrated that intensive insulin therapy will reduce the incidence and progression of microvascular complications in people with IDDM (22). A number of further challenges await laboratory scientists and epidemiologists regarding hyperglycemia in people with diabetes. There is a need to understand the relation of hyperglycemia to pathogenetic mechanisms that lead to the development of specific complications, to develop new methods to detect and physiologically treat hyperglycemia, and to develop better methods of primary and secondary prevention of diabetic complications in people with IDDM and NIDDM.

934 citations


Journal ArticleDOI
TL;DR: This study indicated that patient empowerment is an effective approach to developing educational interventions for addressing the psychosocial aspects of living with diabetes and is conducive to improving blood glucose control.
Abstract: OBJECTIVE The purpose of this study was to determine if participation in a patient empowerment program would result in improved psychosocial self-efficacy and attitudes toward diabetes, as well as a reduction in blood glucose levels. RESEARCH DESIGN AND METHODS This study was conducted as a randomized, wait-listed control group trial. The intervention group received a six-session (one session per week) patient empowerment education program; the control group was assigned to a wait-list. At the end of 6 weeks, the control group completed the six-session empowerment program. Six weeks after the program, both groups provided follow-up data. RESULTS The intervention group showed gains over the control group on four of the eight self-efficacy subscales and two of the five diabetes attitude subscales. Also, the intervention group showed a significant reduction in glycated hemoglobin levels. Within groups, analysis of data from all program participants showed sustained improvements in all of the self-efficacy areas and two of the five diabetes attitude subscales and a modest improvement in blood glucose levels. CONCLUSIONS This study indicated that patient empowerment is an effective approach to developing educational interventions for addressing the psychosocial aspects of living with diabetes. Furthermore, patient empowerment is conducive to improving blood glucose control. In an ideal setting, patient education would address equally blood glucose management and the psychosocial challenges of living with diabetes.

817 citations


Journal ArticleDOI
TL;DR: Excessive insulin secretion in utero, as assessed by AFI concentration, is a strong predictor of IGT in childhood, and AFI and obesity are independently associated with IGT by multiple logistic analysis.
Abstract: OBJECTIVE To test the hypothesis that long-term postnatal development may be modified by metabolic experiences in utero. RESEARCH DESIGN AND METHODS We enrolled offspring of women with pregestational diabetes (this included insulin-dependent diabetes mellitus. [1DDM] and non-insulin-dependent diabetes mellitus [NIDDM]) and gestational diabetes in a prospective study from 1977 through 1983. Fetal /3-cell function was assessed by measurement of arrmiotic fluid insulin (AF1) at 32–38 weeks gestation. Postnatally, plasma glucose and insulin were measured yearly from 1.5 years of age after fasting and 2 h after 1.75 g/kg oral glucose. Control subjects had a single oral glucose challenge at 10-16 years. RESULTS In offspring of diabetic mothers, the prevalence of impaired glucose tolerance (IGT) (2-h glucose concentration >7.8 mmol/1) was: 1.2% at 10 years of age (9 boys and 8 girls) include one girl with NIDDM. IGT was not associated with the etiology of the mother9s diabetes (gestational versus pregestational) or macrosomia at birth. IGT was found in only 3.7% (1 of 27) of adolescents whose AFI was normal (≥100 pmol/l) and 33.3% (12 of 36) of those with elevated AFI ( P CONCLUSIONS In confirmation of our original hypothesis, IGT in the offspring is a long-term complication of maternal diabetes. Excessive insulin secretion in utero, as assessed by AFI concentration, is a strong predictor of IGT in childhood.

625 citations


Journal ArticleDOI
TL;DR: The results indicate that a high intake of fat, especially that of saturated fatty acids, contributes to the risk of glucose intolerance and NIDDM and Foods such as fish, potatoes, vegetables, and legumes may have a protective effect.
Abstract: OBJECTIVE To investigate the role of diet as a predictor of glucose intolerance and non-insulin-dependent diabetes mellitus (NIDDM). RESEARCH DESIGN AND METHODS At the 30-year follow-up survey of the Dutch and Finnish cohorts of the Seven Countries Study, in 1989/1990, men were examined according to a standardized protocol including a 2-h oral glucose tolerance test. Information on habitual food consumption was obtained using the cross-check dietary history method. Those 338 men in whom information on habitual diet was also available 20 years earlier were included in this study. Subjects known as having diabetes in 1989/1990 were excluded from the analyses. RESULTS Adjusting for age and cohort, the intake of total, saturated, and monounsaturated fatty acids and dietary cholesterol 20 years before diagnosis was higher in men with newly diagnosed diabetes in the survey than in men with normal or impaired glucose tolerance. After adjustment for cohort, age, past body mass index, and past energy intake, the past intake of total fat was positively associated with 2-h postload glucose level ( P P P CONCLUSIONS Although the regression coefficients were in general not very large, these results indicate that a high intake of fat, especially that of saturated fatty acids, contributes to the risk of glucose intolerance and NIDDM. Foods such as fish, potatoes, vegetables, and legumes may have a protective effect. In addition, the observed inverse association between vitamin C and glucose intolerance suggests that antioxidants may also play a role in the development of derangements in glucose metabolism.

538 citations


Journal ArticleDOI
TL;DR: Reduced-awareness individuals may benefit from interventions designed to teach them to recognize all of their potential early warning symptoms, and both disease duration and level of glucose control explains their reduced awareness of hypoglycemia.
Abstract: OBJECTIVE To prospectively evaluate the frequency and severity of hypoglycemic episodes in IDDM subjects who declare themselves to have reduced awareness of hypoglycemia, to validate their self-designations in their natural environment, and to determine objectively the presence or absence of autonomic and neuroglycopenic symptoms associated with their low blood glucose (BG) levels. RESEARCH DESIGN AND METHODS A total of 78 insulin-dependent diabetes mellitus (IDDM) subjects (mean age 38.3 ± 9.2 years; duration of diabetes 19.3 ± 10.4 years) completed two sets of assessments separated by 6 months. The assessments included reports of frequency and severity of low BG, symptoms associated with low BG, and a BG symptom/estimation trial using a hand-held computer (HHC). Diaries of hypoglycemic episodes were kept for the intervening 6 months. HbA 1 levels were determined at each assessment. RESULTS Of the subjects, 39 declared themselves as having reduced awareness of hypoglycemia (reduced-awareness subjects). There were no differences between these reduced-awareness subjects and aware subjects with regard to age, sex, disease duration, insulin dose, or HbA 1 . During the HHC trials, reduced-awareness subjects were significantly less accurate in detecting BG P = 0.001) and had significantly fewer autonomic (0.41 ± 0.82 vs. 1.08 ± 1.22, P = 0.006, reduced-awareness vs. aware) and neuroglycopenic (0.44 ± 0.85 vs. 1.18 ± 1.32, P = 0.004, reduced-awareness vs. aware) symptoms per subject. Prospective diary records revealed that reduced-awareness subjects experienced more moderate (351 vs. 238, P = 0.026) and severe (50 vs. 17, P = 0.0062) hypoglycemic events. The second assessment results were similar to the first and verified the reliability of the data. CONCLUSIONS IDDM subjects who believe they have reduced awareness of hypoglycemia are generally correct. They have a history of more moderate and severe hypoglycemia, are less accurate at detecting BG

524 citations


Journal ArticleDOI
TL;DR: Intense stepped insulin therapy in NIDDM patients who have failed glycemic control on pharmacological therapy is effective in maintaining near-normal gly glucose control for > 2 years without excessive severe hypoglycemia, weight gain, hypertension, or dyslipidemia.
Abstract: OBJECTIVE It is not clear whether intensive pharmacological therapy can be effectively sustained in non-insulin-dependent diabetes mellitus (NIDDM). The relative risks and benefits of intensive insulin therapy in NIDDM are not well defined. Accordingly, we designed a feasibility study that compared standard therapy and intensive therapy in a group of NIDDM men who required insulin due to sustained hyperglycemia. RESEARCH DESIGN AND METHODS A prospective trial was conducted in five medical centers in 153 men of 60 ± 6 years of age who had a known diagnosis of diabetes for 7.8 ± 4 years. They were randomly assigned to a standard insulin treatment group (one morning injection per day) or to an intensive therapy group designed to attain near-normal glycemia and a clinically significant separation of glycohemoglobin from the standard arm. A four-step plan was used in the intensive therapy group along with daily self-monitoring of glucose: 1) an evening insulin injection, 2) the same injection adding daytime glipizide, 3) two injections of insulin alone, and 4) multiple daily injections. Patient accrual and adherence, glycohemoglobin (HbA 1c ), side effects, and measurements of endpoints for a prospective long-term trial were assessed. RESULTS Accrual goals were met, mean follow-up time was 27 months (range 18–35 months), and patients kept 98.6% of scheduled visits. After 6 months, the mean HbA 1c in the intensive therapy group was at or below 7.3% and remained 2% lower than the standard group for the duration of the trial. Most of the decrease in the mean HbA 1c in the intensive group was obtained by a single injection of evening intermediate insulin, alone or with daytime glipizide. By the end of the trial, 64% of the patients had advanced to two or more injections of insulin a day, aiming for normal HbA 1c . However, only a small additional fall in HbA 1c was attained. Severe hypoglycemia was rare (two events per 100 patients per year) and not significantly different between the groups, nor were changes in weight, blood pressure, or plasma lipids. There were 61 new cardiovascular events in 40 patients and 10 deaths (6 due to cardiovascular causes). CONCLUSIONS Intense stepped insulin therapy in NIDDM patients who have failed glycemic control on pharmacological therapy is effective in maintaining near-normal glycemic control for > 2 years without excessive severe hypoglycemia, weight gain, hypertension, or dyslipidemia. Cardiovascular event rates are high at this stage of NIDDM. A long-term prospective trial is needed to assess the risk-benefit ratio of intensified treatment of hyperglycemia in NIDDM patients requiring insulin.

397 citations


Journal ArticleDOI
TL;DR: Ginseng therapy elevated mood, improved psychophysical performance, and reduced fasting blood glucose (FBG) and body weight, and Ginseng may be a useful therapeutic adjunct in the management of NIDDM.
Abstract: OBJECTIVE To investigate the effect of ginseng on newly diagnosed non-insulin-dependent diabetes mellitus (NIDDM) patients. RESEARCH DESIGN AND METHODS In this double-blind placebo-controlled study, 36 NIDDM patients were treated for 8 weeks with ginseng (100 or 200 mg) or placebo. Efficacy was evaluated with psychophysical tests and measurements of glucose balance, serum lipids, aminoterminalpropeptide (PIIINP) concentration, and body weight. RESULTS Ginseng therapy elevated mood, improved psychophysical performance, and reduced fasting blood glucose (FBG) and body weight. The 200-mg dose of ginseng improved glycated hemoglobin, serum PIIINP, and physical activity. Placebo reduced body weight and altered the serum lipid profile but did not alter FBG. CONCLUSIONS Ginseng may be a useful therapeutic adjunct in the management of NIDDM.

378 citations


Journal ArticleDOI
TL;DR: Both neuropathy and vasculopathy are strong independent risk factors for the development of diabetic foot ulcers, and the strongest risk factor is impaired cutaneous oxygenation.
Abstract: OBJECTIVE To describe the relative contributions of neurological and vascular abnormalities to the overall risk of diabetic foot ulceration. RESEARCH DESIGN AND METHODS A case-control study of diabetic veterans from the Seattle Veterans Affairs Medical Center was conducted using data collected from 46 patients with diabetic foot ulcers and 322 control subjects. Neuropathy was determined by vibratory, monofilament, and tendon reflex testing. Macro-vascular disease was measured by ankle-arm blood pressure index, and cutaneous perfusion was measured by transcutaneous oxygen tension (TcPO 2 ) on the dorsal foot. A multi variate logistic regression model was used to adjust for confounding variables and to calculate the odds ratios (ORs) for each independent risk factor. RESULTS Three variables were significant independent predictors of foot ulceration: absence of Achilles tendon reflexes (adjusted OR 6.48, 95% confidence interval [CI] 2.37–18.06), insensate to the 5.07 monofilament (adjusted OR 18.42, 95% CI 3.83–88.47), and TcPO 2 CONCLUSIONS Both neuropathy and vasculopathy are strong independent risk factors for the development of diabetic foot ulcers. In our model, the strongest risk factor is impaired cutaneous oxygenation. However, in the clinical setting, sensory examination with a 5.07 monofilament probably remains the single most practical measure of risk assessment.

374 citations


Journal ArticleDOI
TL;DR: These studies suggest that LA improves SDN, in significant part by reducing the effects of oxidative stress, and the drug may have potential in the treatment of human diabetic neuropathy.
Abstract: OBJECTIVE To determine whether lipoic acid (LA) will reduce oxidative stress in diabetic peripheral nerves and improve neuropathy. RESEARCH DESIGN AND METHODS We used the model of streptozotocin-induced diabetic neuropathy (SDN) and evaluated the efficacy of LA supplementation in improving nerve blood flow (NBF), electrophysiology, and indexes of oxidative stress in peripheral nerves affected by SDN, at 1 month after onset of diabetes and in age-matched control rats. LA, in doses of 20, 50, and 100 mg/kg, was administered intraperitoneally five times per week after onset of diabetes. RESULTS NBF in SDN was reduced by 50% LA did not affect the NBF of normal nerves but improved that of SDN in a dose-dependent manner. After 1 month of treatment, LA-supplemented rats (100 mg/kg) exhibited normal NBF. The most sensitive and reliable indicator of oxidative stress was reduction in reduced glutathione, which was significantly reduced in streptozotocin-induced diabetic and alpha-tocopherol-deficient nerves; it was improved in a dose-dependent manner in LA-supplemented rats. The conduction velocity of the digital nerve was reduced in SDN and was significantly improved by LA. CONCLUSIONS These studies suggest that LA improves SDN, in significant part by reducing the effects of oxidative stress. The drug may have potential in the treatment of human diabetic neuropathy.

Journal ArticleDOI
TL;DR: Diabetes self-management education is the process of providing the person with diabetes with the knowledge and skills needed to perform self-care, manage crises, and make lifestyle changes required to successfully manage this disease.
Abstract: Since the earliest days of insulin therapy, health care providers have discovered that simply prescribing the correct dose of insulin, oral agents, or correct meal plans is not enough to achieve adequate metabolic control or to prevent medical crises resulting from diabetes. Severe knowledge deficits in self-management skills such as medication administration, glucose testing, diet, sick day guidelines, and foot care have been identified in 50-80% of diabetic adults (1-6) and children (7). Patient hospitalizations for uncontrolled diabetes are often attributed to deficiencies in diabetes knowledge and self-management skills. A survey of hospitals in Rhode Island revealed poor diabetes control as the cause for admission of 33% of patients with diabetes during a 4-year period (8). Similar potentially preventable conditions (hyperglycemia, hypoglycemia, and diabetic ketoacidosis) accounted for 24% of emergency room visits by patients with diabetes at one hospital (9). It may be argued that these adverse events resulted from poor adherence to self-management skills rather than a knowledge deficit. However, inappropriate self-care behaviors may reflect poor understanding about diabetes or the rationale for treatment (1) or prior exposure to misguided treatment or teaching (10). Background and definition Diabetes self-management education is the process of providing the person with diabetes with the knowledge and skills needed to perform self-care, manage crises, and make lifestyle changes required to successfully manage this disease. The goal of the process is to enable the patient to become the most knowledgeable and hopefully the most active participant in his or her diabetes care. The term selfmanagement education emphasizes the need for people with diabetes to manage their diabetes on a day-to-day basis. For this reason the terms diabetes education and self-management education will refer to the same process. More than 50% of people with diabetes receive limited or no diabetes selfmanagement education. In a nationwide sample, 41% of people with type I diabetes, 51% of people with insulin-treated type II diabetes, and 76% of people with non-insulin-treated type II diabetes reported having never attended a diabetes education class, course, or any other education program about diabetes (11).

Journal ArticleDOI
TL;DR: The levels of HbA1c, GA, and FA do not reflect the simple mean but reflect the weighted mean of the preceding plasma glucose level over a considerably longer period than was previously speculated.
Abstract: OBJECTIVE To examine the kinetics of HbA 1c , glycated albumin (GA), and fructosamine (FA) levels in response to plasma glucose change and their relationship with the preceding plasma glucose level. RESEARCH DESIGN AND METHODS The time courses of HbA 1c , GA, and FA after acute glycemic normalization were observed in nine patients with newly diagnosed non-insulin-dependent diabetes mellitus and compared with theoretical ones. Their weight functions against preceding plasma glucose level were analyzed assuming a stepwise plasma glucose change and compared with the theoretical prediction. RESULTS The fasting plasma glucose level was acutely normalized after admission with a half-time of 6.3 ± 2.4 days (mean ± SD). The HbA 1c level decreased linearly during the initial 2 months with a half-time of 34.6 ± 10.1 days, followed by a gradual decrease thereafter. GA and FA levels decreased very rapidly during the initial 2–3 weeks with half-times of 17.1 ± 2.8 and 12.2 ± 4.8 days, respectively, followed by a gradual decrease thereafter. The time courses of HbA 1c , GA, and FA agreed well with theoretically estimated decay curves. Experimental values of weight functions against the preceding plasma glucose level agreed well with the theoretical prediction. The weight functions for glycated proteins had maximum values on the days just before the measurement of glycated proteins and gradually decreased with an increasing time interval. The lengths of the periods over which the weight functions for HbA 1c , GA, and FA extend back were estimated to be roughly 100, 40, and 30 days, respectively. CONCLUSIONS The levels of HbA 1c , GA, and FA do not reflect the simple mean but reflect the weighted mean of the preceding plasma glucose level over a considerably longer period than was previously speculated.

Journal ArticleDOI
TL;DR: Walking, which can be safely performed and easily incorporated into daily life, can be recommended as an adjunct therapy to diet treatment in obese NIDDM patients, not only for BW reduction, but also for improvement of insulin sensitivity.
Abstract: OBJECTIVE To evaluate the effects of walking combined with diet therapy (1,000–1,600 kcal/day) on insulin sensitivity in obese non-insulin-dependent diabetes mellitus (NIDDM) patients. RESEARCH DESIGN AND METHODS Subjects were divided into two groups: 10 patients were managed by diet alone (group D), and 14 patients were placed in the diet and exercise group (group DE). Group DE was instructed to walk at least 10,000 steps/day on a flat field as monitored by pedometer (19,200 ± 2,100 steps/day), and group D was told to maintain a normal daily routine (4,500 ± 290 steps/day). A glucose clamp procedure at an insulin infusion rate of 40 mU · m −2 · min −1 was performed before and after the 6-; to 8-week training program. Mean serum insulin concentrations ranged from 720 to 790 pmol/l. RESULTS While body weight (BW) in groups D and DE decreased significantly ( P that in group D (7.8 ± 0.8 vs. 4.2 ± 0.5 kg, P −1 · min −1 ( P −1 · min −1 ( P P = 0.0005) for the improvement of MCR. Significant correlations were also observed between Δ MCR and average steps per day ( r = 0.7257, P CONCLUSIONS Walking, which can be safely performed and easily incorporated into daily life, can be recommended as an adjunct therapy to diet treatment in obese NIDDM patients, not only for BW reduction, but also for improvement of insulin sensitivity.

Journal ArticleDOI
TL;DR: The use of specially designed shoes is effective in preventing relapses in diabetic patients with previous ulceration, and the use of therapeutic shoes was negatively associated with foot ulcer relapses.
Abstract: OBJECTIVE To evaluate the efficacy of manufactured shoes specially designed for diabetic patients (Podiabetes by Buratto Italy) to prevent relapses of foot ulcerations. RESEARCH DESIGN AND METHODS A prospective multicenter randomized follow-up study of patients with previous foot ulcerations was conducted. Patients were alternatively assigned to wear either their own shoes (control group, C; n = 36) or therapeutic shoes (Podiabetes group, P; n = 33). The number of ulcer relapses was recorded during 1-year follow-up. RESULTS Both C and P groups had similar risk factors for foot ulceration (i.e., previous foot ulceration, mean vibratory perception threshold > 25 mV). After 1 year, the foot ulcer relapses were significantly lower in P than in C (27.7 vs. 58.3%; P = 0.009; odds ratio 0.26 [0.2–1.54]). In a multiple regression analysis, the use of therapeutic shoes was negatively associated with foot ulcer relapses (coefficient of variation = −0.315; 95% confidence interval = −0.54 to −0.08; P = 0.009). CONCLUSIONS The use of specially designed shoes is effective in preventing relapses in diabetic patients with previous ulceration.

Journal ArticleDOI
TL;DR: It is suggested that many investigators are unclear about a number of issues involving the use of areas under the curve (AUCs), so issues in the calculation, use, meaning, and presentation of AUCs are reconsidered.
Abstract: Recently, several articles appearing in the diabetes literature have suggested that many investigators are unclear about a number of issues involving the use of areas under the curve (AUCs). This prompted us to reconsider issues in the calculation, use, meaning, and presentation of AUCs. We discuss five issues: 1) What is a curve and an area? 2) How should one graphically present a group's curve? 3) How should one calculate AUCs? 4) Should one subtract baseline values from outcome values before calculating AUCs? And 5) are AUCs the best way to combine multiple readings into a single index?

Journal ArticleDOI
TL;DR: In men, dietary habits may unfavorably influence glucose tolerance independent of obesity, while in women, the association of body mass index with 2-h glucose was fully accounted for by the waist-to-hip ratio.
Abstract: OBJECTIVE To study the prevalence and determinants of glucose intolerance in a general Caucasian population. RESEARCH DESIGN AND METHODS A random sample of 50- to 74-year old Caucasians ( n = 2,484) underwent oral glucose tolerance tests. Multiple regression analyses were performed to study the association of 2-h postload plasma glucose values with potential determinants. RESULTS Prevalence of known and newly detected diabetes and impaired glucose tolerance was 3.6, 4.8, and 10.3%, respectively. In women, but not in men, the association of body mass index with 2-h glucose was fully accounted for by the waist-to-hip ratio. Maternal history of diabetes was twice as prevalent as paternal history, but paternal history only was associated with 2-h glucose. In addition, paternal history was a stronger determinant in men than in women. An independent positive association with 2-h plasma glucose was found for alcohol use of > 30 g/day in women and for intake of total protein, animal protein, and polyunsaturated fatty acids in men. An independent inverse association with 2-h plasma glucose was demonstrated for height (both sexes), alcohol use of ≤ 30 g/day (both sexes), energy intake (in men), and, unexpectedly, current smoking (in men). CONCLUSIONS The prevalence of diabetes in elderly Caucasians was 8.3%. In men, dietary habits may unfavorably influence glucose tolerance independent of obesity.

Journal ArticleDOI
TL;DR: The risk for progression of diabetic retinopathy was increased by initial glycosylated hemoglobin elevations as low as 6 SD above the control mean, which may be due to suboptimal control itself or to the rapid improvement in metabolic control that occurred in early pregnancy.
Abstract: OBJECTIVE To evaluate the role of metabolic control in the progression of diabetic retinopathy during pregnancy. RESEARCH DESIGN AND METHODS We conducted a prospective cohort study of 155 diabetic women in the Diabetes in Early Pregnancy Study followed from the periconceptional period to 1 month postpartum. Fundus photographs were obtained shortly after conception (95% within 5 weeks of conception) and within 1 month postpartum. Glycosylated hemoglobin was measured weekly during the 1st trimester and monthly thereafter. RESULTS In the 140 patients who did not have proliferative retinopathy at baseline, progression of retinopathy was seen in 10.3, 21.1, 18.8, and 54.8% of patients with no retinopathy, microaneurysms only, mild nonproliferative retinopathy, and moderate-to-severe nonproliferative retinopathy at baseline, respectively. Proliferative retinopathy developed in 6.3% with mild and 29% with moderate-to-severe baseline retinopathy. Elevated glycosylated hemoglobin at baseline and the magnitude of improvement of glucose control through week 14 were associated with a higher risk of progression of retinopathy (adjusted odds ratio for progression in those with glycohe-moglobin ≥ 6 SD above the control mean versus those within 2 SD was 2.7; 95% confidence interval was 1.1-7.2; P = 0.039). CONCLUSIONS The risk for progression of diabetic retinopathy was increased by initial glycosylated hemoglobin elevations as low as 6 SD above the control mean. This increased risk maybe due to suboptimal control itself or to the rapid improvement in metabolic control that occurred in early pregnancy. Excellent metabolic control before conception may be required to avoid this increase in risk. Those with moderate-to-severe retinopathy at conception need more careful ophthalmic monitoring, particularly if their diabetes was suboptimally controlled at conception.

Journal ArticleDOI
TL;DR: Intensive therapy was implemented successfully in the DCCT and the metabolic results that occurred with the different treatment regimens indicated that intensive and conventional treatment subjects adhered to their respective insulin injection regimens >97% of the time.
Abstract: OBJECTIVE To describe the methods used to implement intensive and conventional therapies in the Diabetes Control and Complications Trial (DCCT) and the metabolic results that occurred with the different treatment regimens. RESEARCH DESIGN AND METHODS The DCCT was a controlled clinical trial that demonstrated the beneficial effect of intensive therapy on the long-term complications of insulin-dependent diabetes mellitus (IDDM). A total of 1,441 volunteers with IDDM, aged 13–39, from 29 centers in the U.S. and Canada, were randomly assigned to conventional or intensive diabetes therapy. Intensive therapy, which used multiple daily injections (MDI) of insulin (≥3 injections/day) or continuous subcutaneous insulin infusion (CSI1), was implemented by a team that included diabetes nurses, dietitians, behavioral experts, and diabetologists. Volunteers in the intensive treatment group could use MDI or CSII, based on patient and clinic preference, and could switch between therapies over the course of the study. The volunteers were followed for a mean of 6.5 years (range 3–9 years). RESULTS A detailed analysis of implementation of the two treatments indicates that intensive and conventional treatment subjects adhered to their respective insulin injection regimens >97% of the time. Adherence to other elements of intensive treatment was similarly high and resulted in median HbAlc values between 6.7 and 7.2, compared with 8.7–9.2 with conventional therapy, over the course of the study. Severe hypoglycemia occurred three times more often in intensively treated subjects. Although subjects on intensive treatment were not randomly assigned to MDI or CSII, we compared those subjects who used either of these methods for >90% of the study time. CSIIy-treated patients maintained a mean HbAlc of 6.8 vs. 7.0 in MDI-treated subjects during the trial (P < 0.05). The frequency of hypoglycemia with coma and seizure and diabetic ketoacidosis was modestly higher with CSII than with MDI. CONCLUSIONS Intensive therapy was implemented successfully in the DCCT. The detailed description herein will serve to facilitate translation of the DCCT results to the clinical setting.

Journal ArticleDOI
TL;DR: The results of the Diabetes Control and Complications Trial (DCCT) have engendered an intensive review of the philosophy of diabetes care, with a clear indication that the patient must be viewed as a responsible and active decision maker in diabetes care in the 1990s and beyond.
Abstract: The results of the Diabetes Control and Complications Trial (DCCT) have engendered an intensive review of our approach to diabetes care. With major changes in diabetes care in the offing, this is an appropriate time to review one's philosophy of diabetes care in an effort to determine whether our approach is suited to the unique requirements of this lifelong self-managed disease. Although the DCCT represents a monumental scientific achievement, it is not altogether clear how the results of this trial should be translated into improved diabetes care (1-4). As Dr. Skyler pointed out at this year's American Diabetes Association meeting (5), there are potential risks (e.g., micro vascular complications that could have been delayed or prevented) in failing to recommend intensive therapy for patients for whom it would be appropriate, as well as potential risks (e.g., severe episodes of hypoglycemia and the concomitant risk of injury) of implementing intensive therapy in patients who may not be suitable candidates. Dr. Skyler's suggested solution to the aforementioned dilemma was to have patients participate in a careful informed consent process, during which they would be helped to consider both the costs and benefits of engaging in intensive therapy. This proposed solution is a clear indication that the patient must be viewed as a responsible and active decision maker in diabetes care in the 1990s and beyond.

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TL;DR: Several review articles summarize trials documenting that treatment with angiotensin-converting enzyme (ACE) inhibitors (and other antihypertensive agents) in microalbuminuric insulindependent diabetes mellitus and relatively young non-insulin-dependentabetes mellitus (NIDDM) patients decreases albuminuria and is likely to postpone the decline in glomerular nitration rate.
Abstract: U rinary albumin excretion rate (UAER) is the main parameter used in diabetic patients for the clinical evaluation of early renal disease (1-3); likewise, it is a key to other complications (3-5). The parameter is not only related to diagnosis, but it is also important to early intervention, e.g., optimized diabetes care (6), and more specifically, to early antihypertensive treatment (6-10). Several review articles summarize trials documenting that treatment with angiotensin-converting enzyme (ACE) inhibitors (and other antihypertensive agents) in microalbuminuric insulindependent diabetes mellitus (IDDM) and relatively young non-insulin-dependent diabetes mellitus (NIDDM) patients decreases albuminuria and is likely to postpone the decline in glomerular nitration rate (7-9). Optimal diabetic control may be difficult to achieve in some patients with microalbuminuria (11), and the trials in the microalbuminuric patients with this treatment modality do not provide totally coherent results (11-13). However, new data on the microalbuminuric patients in the Diabetes Control and Complications Trial (DCCT) documented a positive effect of intensified treatment (12), but good metabolic control may be problematic in some of these patients, who generally have higher HbAlc values compared with matched normoalbuminuric patients (14). With respect to primary prevention of mi-

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TL;DR: The increased incidence of congestive heart failure and the increased mortality and morbidity in the diabetic patient following myocardial infarction or coronary artery bypass graft can be explained by the presence of diabetic cardiomyopathy.
Abstract: The increased incidence of congestive heart failure and the increased mortality and morbidity in the diabetic patient following myocardial infarction or coronary artery bypass graft can be explained by the presence of diabetic cardiomyopathy. Noninvasive studies in young diabetic patients show no cardiac abnormality, but in older diabetic patients mild cardiac diastolic dysfunction is detectable. This mild cardiomyopathy can become clinically detectable in the presence of hypertension and can be severe in the presence of myocardial ischemia. Microvascular disease is unlikely to cause diabetic cardiomyopathy. Cellular changes, including defects in calcium transport and fatty acid metabolism, may lead to myocellular hypertrophy and myocardial fibrosis, initially causing diastolic dysfunction that may advance to systolic dysfunction. Glycemic control, energetic detection and treatment of hypertension with appropriate antihypertensive agents, and early detection and treatment of ischemic heart disease are essential in preventing and treating diabetic cardiomyopathy.

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TL;DR: Diabetic patients with good long-term glycemic control had a better survival rate than subjects with high average FBG values, and the findings should be interpreted cautiously because possible confounding factors such as dyslipoproteinemia and smoking were not studied.
Abstract: OBJECTIVE To study the influence of long-term glycemic control on mortality in a cohort of newly detected type II diabetic individuals. RESEARCH DESIGN AND METHODS A total of 411 newly detected type II diabetic individuals diagnosed between 1972 and 1987 were followed until 31 December 1989. Clinical data concerning fasting blood glucose (FBG) values, body mass index (BMI), type of treatment, and concomitant diseases were collected during 8 randomly selected years. Long-term glycemic control was measured as annual averages of FBG values during these years. Mortality data were obtained from official registers. RESULTS There were 161 diabetic subjects who died during a mean follow-up time of 7.4 years. In univariate analyses, higher age at diagnosis; higher baseline or average FBG; and the presence of heart disease, cerebrovascular disease, or kidney disease at the beginning or during the course of diabetes were related to higher mortality. Type of diabetes treatment or having a diagnosis of hypertension was not related to mortality. In multiple logistic regression analyses, age at diagnosis and average FBG were independently related to all-cause ( P = 0.0002), cardiovascular ( P = 0.0006), and ischemic heart disease mortality ( P = 0.03). No correlations between glycemic control and noncardiovascular deaths were found. In a Cox9s regression analysis, average FBG was significantly related to length of survival when age at diabetes diagnosis was taken into account ( P CONCLUSIONS Diabetic patients with good long-term glycemic control had a better survival rate than subjects with high average FBG values. The findings should be interpreted cautiously because possible confounding factors such as dyslipoproteinemia and smoking were not studied.

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TL;DR: Prevalence rates of diabetes and impaired glucose tolerance in three American Indian populations were estimated using standardized diagnostic criteria, and diabetes rates were positively associated with age, level of obesity, amount of Indian ancestry, and parental diabetes status.
Abstract: OBJECTIVE To estimate prevalence rates of diabetes and impaired glucose tolerance (IGT) in three American Indian populations, using standardized diagnostic criteria, and to assess the association of diabetes with the following selected possible risk factors: age, obesity, family history of diabetes, and amount of Indian ancestry. RESEARCH DESIGN AND METHODS This cross-sectional study involved enrolled members, men and women aged 45-74 years, of 13 American Indian tribes or communities in Arizona, Oklahoma, and South and North Dakota. Eligible participants were invited to the clinic for a personal interview and a physical examination. Diabetes and IGT status were defined by the World Health Organization criteria and were based on fasting plasma glucose and oral glucose tolerance test results. Data on age, family history of diabetes, and amount of Indian ancestry were obtained from the personal interview, and measures of obesity included body mass index, percentage body fat, and waist-to-hip ratio. RESULTS A total of 4,549 eligible participants were examined, and diabetes status was determined for4,304(1,446 in Arizona, 1,449 in Oklahoma, and 1,409 in the Dakotas). In all three centers, diabetes was more prevalent in women than in men. Arizona had the highest age-adjusted rates of diabetes: 65% in men and 72% in women. Diabetes rates in Oklahoma (38% in men and 42% in women) and South and North Dakota (33% in men and 40% in women), although considerably lower than in Arizona, were several times higher than those reported for the U.S. population. Rates of IGT among the three populations (14-17%) were similar to those in the U.S. population. Diabetes rates were positively associated with age, level of obesity, amount of Indian ancestry, and parental diabetes status. CONCLUSIONS Diabetes is found in epidemic proportions in Native American populations. Prevention programs and periodic screening should be implemented among American Indians. Standards of care and intervention have been developed by the Indian Health Service for individuals in whom diabetes is diagnosed. These programs shoula be expanded to include those with IGT to improve glycemie control or to reduce the risk of development of diabetes as well as to reduce the risk of diabetic complications.

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TL;DR: Pregnancy is complicated by diabetes more often than was previously believed and more frequent testing may further increase the apparent prevalence of GDM.
Abstract: OBJECTIVE To determine the prevalence of pregnancy complicated by diabetes in a representative sample of the U.S. population. RESEARCH DESIGN AND METHODS We analyzed data from a multistaged cross-sectional probability sample of live births recorded in the U.S. in 1988 for women 15–49 years of age. The main outcome measure was pregnancy complicated by diabetes. RESULTS Diabetes was present in congruent to 154,000 (4%) of all pregnancies in the U.S. Gestational diabetes mellitus (GDM) accounted for 135,000 of such pregnancies (88%), non-insulin-dependent diabetes mellitus (NIDDM) for 12,000 (8%), and insulin-dependent diabetes mellitus for 7,000 (4%). On average, the mothers with NIDDM (29.6 years) and GDM (29.3 years) were older than mothers whose pregnancies were not complicated by diabetes (26.2 years; P CONCLUSIONS Pregnancy is complicated by diabetes more often than was previously believed. More frequent testing may further increase the apparent prevalence of GDM.

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TL;DR: This classification tree performed significantly better than an existing questionnaire and should serve as a simple, noninvasive, and potentially cost-effective tool for diagnosing diabetes in the U.S.
Abstract: OBJECTIVE To develop a simple questionnaire to prospectively identify individuals at increased risk for undiagnosed diabetes. RESEARCH DESIGN AND METHODS People with newly diagnosed diabetes ( n = 164) identified in the Second National Health and Nutrition Examination Survey and those with neither newly diagnosed diabetes nor a history of physician-diagnosed diabetes ( n = 3,220) were studied. Major historical risk factors for undiagnosed non-insulin-dependent diabetes were defined, and classification trees were developed to identify people at higher risk for previously undiagnosed diabetes. The sensitivity, specificity, and predictive value of the classification trees were described and compared with those of an existing questionnaire. RESULTS The selected classification tree incorporated age, sex, history of delivery of a macrosomic infant, obesity, sedentary lifestyle, and family history of diabetes. In a representative sample of the U.S. population, the sensitivity of the tree was 79%, the specificity was 65%, and the predictive value positive was 10%. CONCLUSIONS This classification tree performed significantly better than an existing questionnaire and should serve as a simple, noninvasive, and potentially cost-effective tool for diagnosing diabetes in the U.S.

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TL;DR: This study shows the importance of recognizing the prevalence of mismanagement among adolescents and the existence and prevalence of adolescent-generated diabetes management techniques.
Abstract: OBJECTIVE To document the existence and prevalence of adolescent-generated diabetes management techniques. RESEARCH DESIGN AND METHODS One hundred forty-four adolescents completed the confidential questionnaire developed for this study. Glycohemo-globin was also obtained for each individual. RESULTS Within the 10 days before their clinic visit, many adolescents admitted to engaging in various mismanagement behaviors, with 25% admitting to missing shots. Parents tend to underestimate adolescent mismanagement. Missing shots was significantly related to poor control ( P P CONCLUSIONS This study shows the importance of recognizing the prevalence of mismanagement among adolescents.

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TL;DR: Topical application of bFGF has no advantage over placebo for healing chronic neuropathic diabetic ulcer of the foot because diabetes causes significant wound-healing defects and using a single growth factor might be insufficient to accelerate wound closure of diabetic ulcers.
Abstract: OBJECTIVE To assess the efficacy and safety of topical human recombinant basic fibroblast growth factor (bFGF) on the healing of diabetic neurotrophic foot ulcers. RESEARCH DESIGN AND METHODS Seventeen diabetic patients suffering from chronic neuropathic ulcer of the plantar surface of the foot entered a pilot, randomized, double-blind study comparing local application of bFGF with placebo. Main inclusion criteria were a typical neuropathic ulcer of Wagner grade I-III, more than 0.5 cm in the largest diameter, with an abnormally high vibration perception threshold in the absence of significant peripheral vascular disease or wound infection. bFGF or placebo was applied daily during the 6 weeks as inpatients then twice a week for 12 weeks. Evolution of ulcer size was assessed through weekly clinical examination and computerized photographs. RESULTS In the bFGF group, three of nine ulcers healed compared with five of eight in the placebo group (NS). The weekly reduction in ulcer perimeter and area was identical in both groups, as was the rate of linear advance from entry to the 6th week of treatment (bFGF: 0.053 ± 0.048 mm vs. placebo: 0.116 ± 1.129 mm): the same result was obtained at the 11th week. Moreover, percent healed area at the end of the study did not differ significantly. No side effects were observed during bFGF application. CONCLUSIONS Topical application of bFGF has no advantage over placebo for healing chronic neuropathic diabetic ulcer of the foot. Because diabetes causes significant wound-healing defects, we hypothesized that using a single growth factor might be insufficient to accelerate wound closure of diabetic ulcers.

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TL;DR: It is concluded that minor trauma in diabetic patients with peripheral neuropathy might result in a fracture in those with a reduced bone density and thus trigger the development of Charcot neuroarthropathy.
Abstract: OBJECTIVE To determine factors that might be associated with the development of Charcot neuroarthropathy RESEARCH DESIGN AND METHODS This cross-sectional prevalence study examined neurological function and bone density in matched groups of neuropathic diabetic patients with and without radiological evidence of Charcot neuroarthropathy RESULTS Patients with Charcot neuroarthropathy had a global impairment of neurological function that was significantly greater than that of otherwise matched non-Charcot neuropathic patients All 17 Charcot patients had evidence of autonomic neuropathy compared with 10 of the control subjects ( P = 003) The Charcot patients had evidence of reduced bone density in the lower limbs compared with the neuropathic control subjects ( P = 0009), but relatively preserved bone density in the spine ( P = 04 vs control subjects) CONCLUSIONS We conclude that minor trauma in diabetic patients with peripheral neuropathy might result in a fracture in those with a reduced bone density and thus trigger the development of Charcot neuroarthropathy

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TL;DR: Controversy abounds on the current classification of diabetes, and while this may not be a major problem in children, it certainly presents a major challenge for researchers and clinicians in the diagnosis of diabetes in adults, particularly in young adults.
Abstract: HOW MANY FACES HAS DIABETES IN ADULTS? — Life would be much easier for researchers and clinicians if there were only one type of diabetes. The reality, however, is that diabetes is not one disease. From the most simple viewpoint, there are two major forms, insulin-dependent diabetes mellitus (IDDM), or type I diabetes, and noninsulin-dependent diabetes mellitus (NIDDM), or type II diabetes (1,2). Both forms are heterogenous, particularly NIDDM, and in addition, there are several less important forms from a numerical perspective (1). Controversy abounds on the current classification of diabetes, and while this may not be a major problem in children, it certainly presents a major challenge for researchers and clinicians in the diagnosis of diabetes in adults, particularly in young adults (3).