Interpreting the results of the Semmes-Weinstein monofilament test: accounting for false-positive answers in the international consensus on the diabetic foot protocol by a new model.

AIMS: The Semmes-Weinstein monofilament is the most widely used test to diagnose the loss of protective sensation. The commonly used protocol of the International Consensus on the Diabetic Foot includes a 'sham' application that allows for false-positive answers. We sought to study the heretofore unexamined significance of false-positive answers. METHODS: Forty-five patients with diabetes and a history of pedal ulceration (Group I) and 81 patients with diabetes but no history of ulceration (Group II) were studied. The three original sites of the International Consensus on the Diabetic Foot at the hallux, 1st metatarsal and 5th metatarsal areas were used. At each location, the test was performed three times: 2 actual and 1 "sham" applications. Scores were graded from 0 to 3 based upon correct responses. Determination of loss of protective sensation was performed with and without calculating a false-positive answer as a minus 1 score. RESULTS: False-positive responses were found in a significant percentage of patients with and without history of ulceration. Introducing false-positive results as minus 1 into the test outcome significantly increased the number of patients diagnosed with loss of protective sensation in both groups. CONCLUSIONS: False-positive answers can significantly affect Semmes-Weinstein monofilament test results and the diagnosis of LOPS. A model that accounts for false-positive answers is offered.

Pilot study on the significance of random intrasite placement of the Semmes-Weinstein monofilament.

BACKGROUND: The possible effect of random intrasite placement on the outcome of the Semmes-Weinstein monofilament (SWF) test is not known. We sought to determine the significance of this variable in the diagnosis of loss of protective sensation (LOPS) in patients with diabetes. METHODS: Forty-five patients with diabetes with history of pedal ulceration (group 1), 81 patients with diabetes without history of ulceration (group 2) and 21 non-diabetic controls (group 3) were studied. The three original sites of the International Consensus on the Diabetic Foot at the hallux, first and fifth sub-metatarsal areas were divided into peripheral and interior zones resulting in a total of six zones. RESULTS: Mean total scores of monofilament test were significantly lower in peripheral zones as compared with interior zones of both feet in all three groups and affected the resulting percentage of loss of protective sensation. CONCLUSIONS: Intrasite monofilament placement can significantly affect monofilament test results and the diagnosis of loss of protective sensation. A model that corrects the effect of random intrasite placement is needed.

Effect of acute psychotic stress in nondiabetic subjects on beta-cell function and insulin sensitivity.

OBJECTIVE: To determine the effect of acute psychotic stress on glucose homeostasis in nondiabetic subjects. RESEARCH DESIGN AND METHODS: Beta-cell function and insulin sensitivity were determined by the homeostasis model assessment in 39 nondiabetic patients with acute psychotic stress reaction admitted to a psychiatric ward. The clinical global impression (CGI) score was used to evaluate the level of psychological stress. Patients were assessed on admission, after 2 weeks, before discharge, and 6 months after discharge. RESULTS: The mean CGI score decreased significantly with time: 5.3 +/- 0.8 and 1.6 +/- 0.7 on admission and predischarge, respectively (P < 0.001). This was associated with a significant reciprocal increase of mean beta-cell function from 96.8 +/- 33.2 to 134.4 +/- 60% at admission and postdischarge, respectively (P < 0.003), and a decrease of mean insulin sensitivity from 101.7 +/- 36 to 77.1 +/- 34.8% (P < 0.001). In contrast, mean glucose and HbA(1c) levels did not change significantly. Subgroup analysis demonstrated that patients with the highest stress score on admission (> or =6) had significantly higher glucose (P = 0.01) and insulin levels (P = 0.04) than patients with lower score (<6). Furthermore, insulin sensitivity and CGI score on admission were inversely correlated (r = -0.38, P < 0.02). In these patients, no correlation was found between beta-cell function or insulin sensitivity and BMI. CONCLUSIONS: These data indicate that beta-cell function and insulin sensitivity are inversely correlated with acute psychotic stress.

Feasibility and safety of multiple daily insulin injections in general medicine wards.

AIM: Intravenous insulin improves clinical outcome in patients hospitalized in intensive care units. Whether glucose control with multiple daily subcutaneous insulin injections (MDI) is beneficial in patients hospitalized in general medical wards is unknown. We tested the feasibility, safety and efficacy of glucose control with MDI in diabetic patients hospitalized in a general medicine ward. METHODS: Eighty-eight adults with diabetes mellitus were studied in an internal medicine department. All patients were treated with subcutaneous pre-meal insulin analogue and Glargin insulin. A conservative and an intensified protocol was tested. RESULTS: Mean daily glucose levels decreased in the conservatively treated patients from 275+/-71 mg/dl at day 1 to 197.0+/-60 mg/dl at day 4 of hospitalization p=0.0001 and in the intensified protocol to 191+/-38 mg/dl already on day 1 remaining stable throughout the hospitalization. A mean daily glucose <180 mg% was reached by day 2 in 48% of patients in the intensified and in 32% in the conservative groups. Only one serious event of hypoglycemia was noted in the intensified group. CONCLUSION: Intensive insulin treatment with MDI is feasible, safe and efficacious in general medicine wards.

TH1/TH2 cytokine secretion of first degree relatives of T1DM patients.

Th1/Th2 cytokine imbalance has been demonstrated in Type 1 diabetes (T1DM) patients. We characterized the peak levels, secretory pattern and total cytokine production of the Th1 cytokines (IL-2 and IFN gamma) and Th2 cytokines (IL-4 and IL-10), by stimulated peripheral blood mononuclear cells of twenty six first-degree relatives of T1DM patients, and eleven matched controls. At enrollment, first degree relatives demonstrated a significant increase in peak and overall secretion of IL-2; P<0.01 and P<0.005 respectively and IL-4 cytokine; P<0.05 and P<0.01 respectively, as compared to normal controls. Their mean IFN gamma secretion increased significantly, P<0.05, after one year while their higher IL-2 and IL-4 secretion remained unchanged. Ab-negative and Ab-positive relatives demonstrated a similar cytokine secretion pattern. Four relatives all Ab positive, developed diabetes: Peak IL-4 levels were low in three and markedly decreased within one year in one of these relatives, while peak IL-2 and IFN gamma levels were elevated in all of them. These data demonstrate that secretion of both Th1 and Th2 cytokines is increased in first-degree relatives of T1DM patients independently of their diabetes-associated autoantibodies. The presence of low IL-4 and elevated IL-2 and IFN gamma levels in autoAb positive relatives is associated with progression to overt disease.

Fibromyalgia in diabetes mellitus.

OBJECTIVE: The aim of this study was to evaluate the prevalence of fibromyalgia (FM) in patients with diabetes mellitus (DM). SUBJECTS: The study included 100 consecutive unselected patients with DM attending our diabetes clinic. Patients were divided into two groups: 45 patients with type 1 diabetes and 55 patients with type 2 diabetes. A group of 50 healthy hospital staff members served as controls. The FM was diagnosed according to the 1990 American College of Rheumatology criteria. Counts of 18 tender points were performed by thumb palpation and assessed by dolorimeter. Routine biochemical tests and levels of HbA(1c) were recorded in each patient. RESULTS: The main outcome measure was the association of FM with DM. Fibromyalgia was diagnosed in 17 patients (17%) with DM and in only one (2%) healthy control ( P=0.008). No differences in patients were noted in the prevalence of FM between type 1 and type 2 diabetes (18.5% vs 15.5%, respectively). Patients with both FM and DM had significantly higher levels of HbA(1c) than DM patients without FM (9.2+/-1.1% vs 6.4+/-1.5%) ( P<0.05). Similarly, the numbers of tender points, pain scores, and the prevalence of sleep disturbances, fatigue, and headaches were higher in this group of patients. A significant correlation was observed between the numbers of tender points and HbA(1c) levels in the DM patients with FM ( r=0.72, P=0.027). CONCLUSION: Fibromyalgia is a common finding in patients with types 1 and 2 diabetes, and its prevalence could be related to control of the disease. As with other diabetes complications, FM might be prevented by improved control of blood glucose levels.