Healthcare resource use, direct and indirect costs of hypoglycemia in type 1 and type 2 diabetes, and nationwide projections. Results of the HYPOS-1 study.

BACKGROUND AND AIMS: To obtain an accurate picture of the total costs of hypoglycemia, including the indirect costs and comparing the differences between type 1 (T1DM) and type 2 diabetes mellitus (T2DM). METHODS AND RESULTS: HYPOS-1 was a multicenter, retrospective cohort study which analyzed the data of 2229 consecutive patients seen at 18 diabetes clinics. Data on healthcare resource use and indirect costs by diabetes type were collected via a questionnaire. The domains of inpatient admission and hospital stay, work days lost, and third-party assistance were also explored. Resource utilization was reported as estimated incidence rates (IRs) of hypoglycemic episodes per 100 person-years and estimated costs as IRs per person-years. For every 100 patients with T1DM, 9 emergency room (ER) visits and 6 emergency medical service calls for hypoglycemia were required per year; for every 100 patients with T2DM, 3 ER visits and 1 inpatient admission were required, with over 3 nights spent in hospital. Hypoglycemia led to 58 work days per 100 person-years lost by the patient or a family member in T1DM versus 19 in T2DM. The costs in T1DM totaled €90.99 per person-year and €62.04 in T2DM. Direct and indirect costs making up the total differed by type of diabetes (60% indirect costs in T1DM versus 43% in T2DM). The total cost associated with hypoglycemia in Italy is estimated to be €107 million per year. CONCLUSIONS: Indirect costs meaningfully contribute to the total costs associated with hypoglycemia. As compared with T1DM, T2DM requires fewer ER visits and incurs lower indirect costs but more frequent hospital use.

[After the 2001 European Society of Cardiology Guidelines: is it possible to reduce the number of patients with syncope to be hospitalized?]. / Dopo le Linee Guida 2001 della Società Europea di Cardiologia: è possibile ridurre il numero di pazienti con sincope da ospedalizzare?

AIM: The aim of this paper was to evaluate how many patients with syncope should be hospitalized according to the 2001 European Society of Cardiology (ESC) Guidelines on the management of syncope. METHODS: Starting from August 2002 we prompted a Syncope Unit (SU), as a multi-disciplinary functional structure including the Emergency Department. One of the main objectives of the SU was the implementation of the 2001 ESC Guidelines on Syncope and of the relevant criteria for hospitalization. All the clinical data concerning the patients presenting with syncope were prospectively collected and stored in a dedicated database. RESULTS: Between September 1, 2002 and April 30, 2003, 402 patients were observed for a syncope. Out of these, 19 had a cardiogenic syncope, 3 focal neurologic disorders, 25 a severe trauma, 4 severe orthostatic hypotension and 5 carotid syncope. Therefore, 56 patients out of 402 were found to have indication to therapeutical hospitalization. Among the remaining 346 patients, 83 patients were found to have a structural heart disease and/or an abnormal ECG, 1 had syncope during exercise, 3 presented a familial history of sudden death. Thirty-three were found to have severe comorbidities and further 14 had occasional indication to hospitalization. Thus, 190 out of the 402 patients with syncope (47.3%) presented at least 1 criterion for hospitalization according to the ESC Guidelines. CONCLUSION: The implementation of the ESC Guidelines on Syncope is technically feasible. Nevertheless, even when the Guidelines are strictly observed, a high percentage of patients with syncope has still to be hospitalized. Our data suggest that new criteria should be established for a safe Emergency Department discharge of the patients with syncope, particularly of those with structural heart disease or abnormal ECG.

Biochemical and ultrasound tests for early diagnosis of active neuro-osteoarthropathy (NOA) of the diabetic foot.

OBJECTIVES: To test the effectiveness of a combined approach to an early diagnosis of neuro-osteoarthropathy (NOA) of the diabetic foot, we studied a group of outpatients with active NOA, presenting for the first time to our Diabetic Foot Clinic in 1998, by means of an integrated approach designed to assess bone turnover. PATIENTS AND METHODS: Fifteen consecutive diabetic patients (five Type 1 and ten Type 2 diabetic individuals, age 61.9+/-12.2 years, diabetes duration 18.7+/-8.9 years, HbA(1c) 8.4+/-1.5%) with active NOA (Group 1) were compared to nine diabetic patients with chronic stable NOA (Group 2), 14 neuropathic diabetic patients without NOA (Group 3), 13 non-neuropathic diabetic patients (Group 4) and 15 healthy controls (Group 5). Determination of serum carboxy-terminal collagen telopeptide (ICTP), bone alkaline phosphatase isoenzyme (B-ALP), osteocalcin (BGP) concentrations, as well as urinary excretion of deoxypyridinoline (DPD) were obtained in all individuals for assessment of bone reabsorption and new bone formation. Moreover in all individuals quantitative ultrasound (QUS) of the calcaneal bone was performed and mass density of lumbar spine and femur bone was determined by dual-energy X-ray absorptiometry (DEXA). RESULTS: QUS was significantly lower in the active NOA patients as compared with other groups (P<0.01), while ICTP was higher in both NOA groups (P<0.01). Urinary DPD was higher in the neuropathic non-NOA group (P<0.01) than the other groups, and osteocalcin was higher in healthy controls compared to diabetic patients without NOA. QUS and ICTP were inversely correlated (r=0.44, P=0.000). QUS in the active NOA group was significantly (P<0.01) lower in the affected compared to the unaffected foot. CONCLUSION: Our results indicate a possible role for an integrated approach to the diagnosis and monitoring of NOA involving the diabetic foot. DPD may identify patients at-risk for NOA, ICTP could be tested as a marker for NOA in asymptomatic cases. Finally, QUS of the calcaneal bone may be useful in discriminating active versus quiescent phases.

Sodium carboxyl-methyl-cellulose dressings in the management of deep ulcerations of diabetic foot.

AIMS: To test the safety and effectiveness of carboxyl-methyl-cellulose dressing (Aquacel; ConvaTec, UK) in the management of deep diabetic foot ulcers, a group of consecutive out-patients attending the foot clinic of the Department of Metabolic Diseases was studied. METHODS: Patients were selected according to the following inclusion criteria: a foot ulcer deeper than 1 cm for > 3 weeks, good peripheral blood supply (palpable peripheral pulses or ABPI > 0.9). Exclusion criteria were as follows: active infection, as evident from clinical signs (purulent discharge, redness, swelling, tenderness) and confirmed by culture exams, plasma creatinine > 2 mg/dl, recent episodes of ketoacidosis, malignancies, and any therapy or pathology which might interfere with the healing process. Twenty patients were enrolled in the study and having obtained their informed consent, their lesions were surgically debrided with the complete elimination of all necrotic tissue and debris up to the bleeding healthy tissue; then ulcers were staged and measured, and patients were randomly assigned to two different treatment groups. Patients in group A were dressed with saline-moistened gauze, while patients in group B were dressed with Aquacel according to the manufacturer's instructions. All patients in both groups received special post-operative shoes (Podiabetes; Zeno Buratto, Treviso, Italy) and crutches until complete re-epithelialization. Ulcers were all left to heal by secondary intent. After 8 weeks patients were blindly evaluated for: the rate of reduction of lesional volume (RLV), rate of granulation tissue (GT), number of infective complications (IC). Intralesional (ILTC) and perilesional (PLTC) temperatures were also recorded with a thermocouple surface digital thermometer, and the difference between the two values (Delta TC) was calculated. Healing time (HT, days), was then compared between the two groups. Data were compared by analysis of variance (ANOVA), linear regression, Kaplan-Meier survival analysis and Fisher's exact test. RESULTS: HT was significantly shorter in Group B than in Group A (P < 0.001). RLV was significantly (P < 0.01) higher in Group B patients compared with Group A, as well as GT (P < 0.05). IC were in 1/10 Group B and in 3/10 Group A (P = 0.582). In addition, both ILTC and Delta TC were higher in Group B compared with Group A ones (P < 0.01). CONCLUSIONS: Carboxyl-methyl-cellulose dressings were shown to be safe, effective and well tolerated in the management of non-ischaemic, non-infected deep diabetic foot ulcers.

Impaired ascendant central pathways conduction in impotent diabetic subjects.

OBJECTIVES: Diabetic impotence is generally due to peripheral neuropathy, but a central pathway impairment has also been suggested. We evaluated somatosensory transmission in a group of impotent diabetic men to assess the role of central nervous system (CNS) involvement. MATERIALS AND METHODS: Somatosensory evoked potentials (SEPs) of pudendal (pdn) and posterior tibial (ptn) nerves were recorded in 74 patients. Type and duration of diabetes, severity of sexual dysfunction, medium term metabolic control, occurrence of microangiopathic chronic complications and autonomic neuropathy were evaluated. RESULTS: Our data show an impairment of central conduction times in pdn (25.7%) and ptn (39.2%) greater than peripheral nervous impairment (pdn 12.2%, ptn 8.1%), in impotent diabetic patients without any further major complication. Central nervous conduction delay resulted to be correlated with poor glycemic control. Significant evident autonomic dysfunction was found only in a minority of cases. CONCLUSION: Our data might suggest that altered conduction along CNS and somatic peripheral neuropathy might develop independently. We confirm the hypothesis of a "central diabetic neuropathy" and suggest that central sensory pathways involvement, not related to peripheral impairment, could play a role in the pathogenesis of erectile dysfunction in diabetic patients.

Hardness of plantar skin in diabetic neuropathic feet.

To evaluate if skin hardness in diabetic neuropathic feet was increased and if its eventual modifications could be correlated to the severity of neuropathy, we studied a group of diabetic outpatients with and without neuropathy. Patients, selected among those who were attending their routine screening for diabetic neuropathy at our diabetologic clinic, were divided into two groups according to the presence (ND+) or absence (ND-) of diabetic neuropathy with the criteria of the S. Antonio Consensus Conference on Diabetic Neuropathy. Patients then underwent an evaluation of vibration perception threshold (VPT) by means of a biotesiometer, measurement of skin hardness (DMT) by means of a durometer, and transcutaneous oxygen tension (TcPO2) determination. VPT was determined at allux (VPT-A) and external malleolus (VPT-M), DMT was measured at heel (DMT-H), at medial (DMT-M) and lateral (DMT-L) midfoot, and at posterior midcalf (DTM-C) as a control site; TcPO2 was evaluated at dorsum (TcPO2-D) and at medial midfoot (TcPO2-M), respectively. All measurements were performed on the nondominant side with the patients supine. Patients were compared with age and gender-matched healthy volunteers (Controls), who underwent the same evaluations in the same order. ND+ patients showed higher values of VPT than ND- and Controls, both at first toe and at malleolus analysis of variance (ANOVA) p<0.01), as well of DMT in all the three sites explored (ANOVA, p<0.01). Moreover, ND+ showed no difference in DMT among the sites, while both in ND- and in controls DMT-M was significantly (p<0.05) lower than DMT-H and DMT-L. No difference among the three groups were observed in TcPO2 measurements, and no difference in DMT-C was observed either. A significant correlation was observed between DMT-H and VPT-M (r2 = 0.516) and between DMT-M and VPT-A (r2 = 0.624) in ND+ patients. Skin hardness was diffusely increased in ND+ patients, and this increase strongly correlates with the severity of neuropathy. Simple, noninvasive determination of skin hardness could identify patient at potential risk to develop neuropathic foot ulcers.

Conservative surgical approach versus non-surgical management for diabetic neuropathic foot ulcers: a randomized trial.

To test the efficacy of surgical treatment of non-infected neuropathic foot ulcers compared to conventional non-surgical management, a group of diabetic outpatients attending our diabetic foot clinic were studied. All patients who came to the clinic for the first time from January to December 1995 inclusive with an uncomplicated neuropathic ulcer were randomized into two groups. Group A received conservative treatment, consisting of relief of weight-bearing, regular dressings; group B underwent surgical excision, eventual debridement or removal of bone segments underlying the lesion and surgical closure. Healing rate, healing time, prevalence of infection, relapse during a 6-month period following intervention and subjective discomfort were assessed. Twenty-four ulcers in 21 patients were treated in group A (17 Type 2 DM/3 Type 1 DM, age 63.24 +/- 13.46 yr, duration of diabetes 18.2 +/- 8.41 yr, HbA1c 9.5 +/- 3.8%) and 22 ulcers in 21 patients in group B (19 Type 2 DM/2 Type 1 DM, age 65.53 +/- 9.87yr, duration of diabetes 16.84 +/- 10.61 yr; HbA1c 8.9 +/- 2.2%). Healing rate was lower (79.2% = 19/24 ulcers) in group A than in group B (95.5% = 21/22 ulcers; p < 0.05), and healing time was longer (128.9 +/- 86.60 days vs 46.73 +/- 38.94 days; p < 0.001). Infective complications occurred significantly more often in group A patients (3/24, 12.5% vs 1/22, 4.5%; p < 0.05), as did relapses of ulcerations (8 vs 3; p < 0.01). There were only two minor perioperative complications in group B patients. Patients reported a higher degree of satisfaction in group B (p < 0.01) as well as lower discomfort (p < 0.05) and restrictions (p < 0.05). Thus surgical treatment of neuropathic foot ulcers in diabetic patients proved to be an effective approach compared to conventional treatment in terms of healing time, complications, and relapses, and can be safely performed in an outpatient setting.

Diabetologic in-service education for health professionals from non-diabetological departments.

In order to test whether or not an in-service requalification course on diabetes care for health professionals (HP) of nondiabetological departments can enhance their level of knowledge about diabetes and the quality of care for diabetic inpatients admitted for reasons other than diabetes, we carried out a requalification course involving 171 HP (161 nurses and 10 midwives) from nondiabetological departments of our hospital. Areas of intervention were: general knowledge of diabetes (GKD), bedside monitoring of blood glucose (BMG), insulin preparation and administration (IPA), diagnosis and treatment of hypoglycemic crises (DTH), and hospitalization-related problems (HRP). HP, divided into groups of about 20 each, completed a basal evaluation by means of a 25-item multiple choice questionnaire, and then attended six separate educative sessions, each of focusing on one topic, consisting of a theory lesson and an interactive exercise of equivalent length. At the end of the course, HP were re-evaluated with the same questionnaire, and their skills in BMG, IPA and DTH were tested by means of specific operational checklists, which divided each complex operation into a sequence of single operations, and then compared them with those of a control group of untrained colleagues (CG). The global knowledge of diabetes after the courses significantly improved, as gathered from the percentages of correct answers in each questionnaire (61.82% +/- 23.64% vs 31.18% +/- 20.00%; P < 0.001); separate analysis of different areas evidenced improvements in GKD (72.28% +/- 12.47% vs 31.46% +/- 20.56%; P < 0.01), BMG (68.77% +/- 15.75% vs 37.50% +/- 27.75%; P < 0.01), IPA (72.02% +/- 11.72% vs 33.45% +/- 21.22%; P < 0.05), and DTH (90.76% +/- 6.86% vs 49.82% +/- 26.68%; P < 0.05), but not in HRP. Professional skills profiles of HP, evaluated by measuring the number of errors done performing each task, were significantly (P < 0.001) better than those of CG, for BMG (1.09 +/- 0.73 vs 4.91 +/- 2.01), IPA (2.36 +/- 1.64 vs 5.64 +/- 2.25), and DHT (1.27 +/- 0.94 vs 3.82 +/- 1.12). Linear regression showed a significant (P < 0.001) correlation of skills and knowledge after the course for BMG (r2 = .49), IPA (r2 = .53), and DTH (r2 = .61). Positive although nonspecific indicators of outcomes of the course were the increase (of about 100%) of requests to our metabolic unit for diabetological consultations from other departments as well as the mentioning of diabetes in the diagnosis of discharge, and the 20% increase in the consumption of sticks for BMG. The course produced a significant improvement of knowledge and skills on specific diabetological items among participants.