The quality of care in type 1 and type 2 diabetes - A 2023 update of the AMD Annals Initiative.

AIMS: An initiative of continuous monitoring of the quality of diabetes care, promoted by the Association of Medical Diabetologists, is in place in Italy since 2006 (AMD Annals). The initiative was effective in improving quality of care indicators, assessed periodically through standardized measures. Here, we show the 2023 AMD Annals data on type 2 (T2D) and type 1 (T1D) diabetes. METHODS: A network of over 1/3 of diabetes centers in Italy periodically extracts anonymous data from electronic medical records, using a standardized software. Process, treatment and outcome indicators, and a validated score of overall care, the Q-score, were evaluated. RESULTS: 296 centers provided data on 573,164 T2D (mean age 69.7±11.2 years) and 42,611 T1D subjects (mean age 48.6±16.9 years). A HbA1c value ≤7.0% was documented in 56.3% of patients with T2D and 35.9% of those with T1D. Only 6.6% of T2D patients and 3.5% of those with T1D reached the composite outcome of HbA1c ≤7.0% + LDL-C <70 mg/dl + BP <130/80 mmHg. Notably, only 2.8% and 3.2% of T2D and T1D patients, respectively, showed a Q score <15, which correlates with an 80% higher risk of incident CVD events compared to scores >25. CONCLUSIONS: We documented an overall good quality of care in both T1D and T2D subjects. However, the failure to achieve the targets of the main risk factors, especially if combined, in a still too large proportion of patients testify the difficulty to apply the more and more stringent indications recommended by guidelines in the everyday clinical practice.

Temporal trends in the starting of insulin therapy in type 2 diabetes in Italy: data from the AMD Annals initiative.

AIMS: Opportunities and needs for starting insulin therapy in Type 2 diabetes (T2D) have changed overtime. We evaluated clinical characteristics of T2D subjects undergoing the first insulin prescription during a 15-year-observation period in the large cohort of the AMD Annals Initiative in Italy. METHODS: Data on clinical and laboratory variables, complications and concomitant therapies and the effects on glucose control after 12 months were evaluated in T2D patients starting basal insulin as add-on to oral/non-insulin injectable agents, and in those starting fast-acting in add-on to basal insulin therapy in three 5-year periods (2005-2019). RESULTS: We evaluated data from 171.688 T2D subjects who intensified therapy with basal insulin and 137.225 T2D patients who started fast-acting insulin. Overall, intensification with insulin occurred progressively earlier over time in subjects with shorter disease duration. Moreover, the percentage of subjects with HbA1c levels > 8% at the time of basal insulin initiation progressively decreased. The same trend was observed for fast-acting formulations. Clinical characteristics of subjects starting insulin did not change in the three study-periods, although all major risk factors improved overtime. After 12 months from the starting of basal or fast-acting insulin therapy, mean HbA1c levels decreased in all the three investigated time-periods, although mean HbA1c levels remained above the recommended target. CONCLUSIONS: In this large cohort of T2D subjects, a progressively earlier start of insulin treatment was observed during a long observation period, suggesting a more proactive prescriptive approach. However, after 12 months from insulin prescription, in many patients, HbA1c levels were still out-of-target.

The AMD ANNALS: A continuous initiative for the improvement of type 2 diabetes care.

AIMS: Since 2006, the Italian AMD (Associations of Medical Diabetologists) Annals Initiative promoted a continuous monitoring of the quality of diabetes care, that was effective in improving process, treatment and outcome indicators through a periodic assessment of standardized measures. Here, we show the 2022 AMD Annals data on type 2 diabetes (T2D). METHODS: A network involving ∼1/3 of diabetes centers in Italy periodically extracts anonymous data from electronic clinical records, by a standardized software. Process, treatment and outcome indicators, and a validated score of overall care, the Q-score, were evaluated. RESULTS: 295 centers provided the annual sample of 502,747 T2D patients. Overall, HbA1c value ≤7.0% was documented in 54.6% of patients, blood pressure <130/80 mmHg in 23.0%, and LDL-cholesterol levels <70 mg/dl in 34.3%, but only 5.2% were at- target for all the risk factors. As for innovative drugs, 29.0% of patients were on SGLT2-i, and 27.5% on GLP1-RAs. In particular, 59.7% were treated with either GLP1-RAs or SGLT2-i among those with established cardiovascular disease (CVD), 26.6% and 49.3% with SGLT2-i among those with impaired renal function and heart failure, respectively. Notably, only 3.2% of T2D patients showed a Q score <15, which correlates with a 80% higher risk of incident CVD events compared to scores >25. CONCLUSIONS: The 2022 AMD Annals data show an improvement in the use of innovative drugs and in the overall quality of T2D care in everyday clinical practice. However, additional efforts are needed to reach the recommended targets for HbA1c and major CVD risk factors.

Sex- and gender-differences in chronic long-term complications of type 1 and type 2 diabetes mellitus in Italy.

AIMS: This review summarizes the contribution of Italian diabetologists devoted to a better understanding of the complex relationship linking sex/gender and long-term complications of type 1 (T1DM) and type 2 diabetes (T2DM) over the last fifteen years. DATA SYNTHESIS: Microvascular and macrovascular complications of diabetes show sex- and gender-related differences, involving pathophysiological mechanisms, epidemiological features and clinical presentation, due to the interaction between biological and psychosocial factors. These differences greatly impact on the progression of diabetes and its long-term complications, especially in the cardiovascular, renal and liver districts. CONCLUSION: A better knowledge of such sex- and gender-related characteristics is required for a more precise patient phenotypization, and for the choice of a personalized antihyperglycemic treatment. Despite such mounting evidence, current diabetes clinical guidelines do not as yet adequately consider sex/gender differences.

Intracellular motor-driven transport of rodlike smooth organelles along microtubules.

Molecular motors are fascinating proteins that use the energy of ATP hydrolysis to drive vesicles and organelles along cytoskeleton filaments toward their final destination within the cell. Several copies of these proteins bind to the cargo and take turns transporting the cargo attaching to and detaching from the track stochastically. Despite the relevance of molecular motors to cell physiology, key aspects of their collective functioning are still unknown. In this work we propose a one-dimensional model for the transport of extensive and smooth organelles driven by molecular motors. We ran numerical simulations to study the behavior of the cargo for different motor configurations, focusing on the transport properties observable in the experiments, e.g., average speed of the organelle and variations in length. We found that active motors drive the cargo using two different mechanisms: Either they locate in front of the cargo and pull the organelle or they situate at the cargo lagging edge and push. Variations in the organelle length is in close relation with the fraction of motors in each configuration, which depends on the resisting load. The results of this model were contrasted with experimental data obtained from the tracking of rodlike mitochondria during active transport in Xenopus laevis melanophores.

Cost-effectiveness of sensor-augmented pump therapy in two different patient populations with type 1 diabetes in Italy.

BACKGROUND AND AIMS: Sensor-augmented pump therapy (SAP) combines real time continuous glucose monitoring (CGM) with Continuous Subcutaneous Insulin Infusion (CSII) and provides additional benefits beyond those provided by CSII alone. SAP with automated insulin suspension provides early warning of the onset of hyperglycemia and hypoglycemia and has the functionality to suspend insulin delivery if sensor glucose levels are predicted to fall below a predefined threshold. Aim of this study was to assess the cost-effectiveness of SAP with automated insulin suspension versus CSII alone in type 1 diabetes. METHODS AND RESULTS: Cost-effectiveness analysis was performed using the CORE Diabetes Model. The analysis was performed in two different cohorts: one with high baseline HbA1c and one at elevated risk for hypoglycemic events. Clinical input data were sourced from published data. The analysis was conducted from a societal perspective over a lifetime time horizon; costs and clinical outcomes were discounted at 3% per year. In patients with poor glycemic control, SAP with automated insulin suspension resulted in improved discounted quality-adjusted life expectancy (QALY) versus CSII (12.44 QALYs vs. 10.99 QALYs) but higher mean total lifetime costs (€324,991 vs. €259,852), resulting in an incremental cost effectiveness ratio (ICER) of €44,982 per QALY gained. In patients at elevated risk for hypoglycemia, the ICER was €33,692 per QALY gained for SAP versus CSII. CONCLUSION: In Italy, the use of SAP with automated insulin suspension is associated with projected improvements in outcomes as compared to CSII. These benefits translate into an ICER usually considered as good value for money, particularly in patients at elevated risk of hypoglycemia.

Predictors of treatment response to liraglutide in type 2 diabetes in a real-world setting.

AIMS: There is an unmet need among healthcare providers to identify subgroups of patients with type 2 diabetes who are most likely to respond to treatment. METHODS: Data were taken from electronic medical records of participants of an observational, retrospective study in Italy. We used logistic regression models to assess the odds of achieving glycated haemoglobin (HbA1c) reduction ≥ 1.0% point after 12-month treatment with liraglutide (primary endpoint), according to various patient-related factors. RECursive Partitioning and AMalgamation (RECPAM) analysis was used to identify distinct homogeneous patient subgroups with different odds of achieving the primary endpoint. RESULTS: Data from 1325 patients were included, of which 577 (43.5%) achieved HbA1c reduction ≥ 1.0% point (10.9 mmol/mol) after 12 months. Logistic regression showed that for each additional 1% HbA1c at baseline, the odds of reaching this endpoint were increased 3.5 times (95% CI: 2.90-4.32). By use of RECPAM analysis, five distinct responder subgroups were identified, with baseline HbA1c and diabetes duration as the two splitting variables. Patients in the most poorly controlled subgroup (RECPAM Class 1, mean baseline HbA1c > 9.1% [76 mmol/mol]) had a 28-fold higher odds of reaching the endpoint versus patients in the best-controlled group (mean baseline HbA1c ≤ 7.5% [58 mmol/mol]). Mean HbA1c reduction from baseline was as large as - 2.2% (24 mol/mol) in the former versus - 0.1% (1.1 mmol/mol) in the latter. Mean weight reduction ranged from 2.5 to 4.3 kg across RECPAM subgroups. CONCLUSIONS: Glycaemic response to liraglutide is largely driven by baseline HbA1c levels and, to a lesser extent, by diabetes duration.

Dietary nutritional profile and phenolic compounds consumption in school children of highlands of Argentine Northwest.

The objective of this work was to assess dietary patterns and consumption of phenolic compounds from fruits and vegetables byschoolchildren of high altitude regions from northwest of Argentina. A nutritional survey including food-frequency consumption, 24-h dietary recall and anthropometric measurements was applied to 241 children from 6 to 12years old. The amounts of the different classes of phenolic compounds were established from Food Composition Tables available in phenol-explorer website. Statistics analyses were performed using IBM SPSS 20.0. Nutritional status assessment showed underweight (2.2%), low weight (12.7%), overweight (12.7%) and obesity (7.4%). Mean intake of phenolic compounds was 412mg/day. Most consumed foods were infusions and sugar products, consumption of vegetables, fruits and dairy products were low compared to recommendations for this age. Considering that polyphenols have protective health effects, its low consumption could be a risk of development of chronic non communicable diseases.

Titanium-released from dental implant enhances pre-osteoblast adhesion by ROS modulating crucial intracellular pathways.

It is important to understand the cellular and molecular events that occur at the cell-material interface of implants used for bone repair. The mechanisms involved in the initial stages of osteoblast interactions with the surface of the implant material must be decisive for cell fating surrounding them. In order to address this issue, we decided to investigate if conditioned medium for dental implants was able to modulate murine pre-osteoblast metabolism. First, we determined the concentration of titanium (Ti)-containing conditioned medium and found that it was 2-fold increased (p < 0.0001). We have reported that this conditioned medium significantly up-modulated pre-osteoblast adhesion up to 24 h (p < 0.0001). In parallel, our results showed that both phosphorylations of FAK (focal adhesion kinase) at Y397 (p < 0.0011) and Cofilin at Ser03 (p < 0.0053) were also up-modulated, as well as for Rac1 expression (p < 0.0175); both of them are involved with cell adaptation by rearranging cytoskeleton actin filaments. Thereafter, Ti-containing medium stimulated ROS (reactive oxygen species) production by pre-osteoblast cells, and it is very possible that ROS compromised PTP-1B (protein tyrosine phosphatase 1B) activation since PTP1B was down-phosphorylated (p < 0.0148). The low PTP activity guarantees the phosphorylation of FAK at Y-residue, causing better pre-osteoblast adhesion in response to Ti-containing medium. Altogether, these data indicate that ROS indirectly modulate FAK phosphorylation in response to Ti-released from dental implants. Taken the results in account, these data showed for the first time that the implanted dental device is able to dynamically affect surrounding tissues, mainly by promoting a better performance of the pre-osteoblast cells. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 105A: 2968-2976, 2017.

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.

Mesenchymal stem cells are enriched in head neck squamous cell carcinoma, correlates with tumour size and inhibit T-cell proliferation.

BACKGROUND: Cancer is a multifactorial disease not only restricted to transformed epithelium, but also involving cells of the immune system and cells of mesenchymal origin, particularly mesenchymal stem cells (MSCs). Mesenchymal stem cells contribute to blood- and lymph- neoangiogenesis, generate myofibroblasts, with pro-invasive activity and may suppress anti-tumour immunity. METHODS: In this paper, we evaluated the presence and features of MSCs isolated from human head neck squamous cell carcinoma (HNSCC). RESULTS: Fresh specimens of HNSCC showed higher proportions of CD90+ cells compared with normal tissue; these cells co-expressed CD29, CD105, and CD73, but not CD31, CD45, CD133, and human epithelial antigen similarly to bone marrow-derived MSCs (BM-MSCs). Adherent stromal cells isolated from tumour shared also differentiation potential with BM-MSCs, thus we named them as tumour-MSCs. Interestingly, tumour-MSCs showed a clear immunosuppressive activity on in vitro stimulated T lymphocytes, mainly mediated by indoelamine 2,3 dioxygenase activity, like BM-MSCs. To evaluate their possible role in tumour growth in vivo, we correlated tumour-MSC proportions with neoplasm size. Tumour-MSCs frequency directly correlated with tumour volume and inversely with the frequency of tumour-infiltrating leukocytes. CONCLUSIONS: These data support the concept that tumour-MSCs may favour tumour growth not only through their effect on stromal development, but also by inhibiting the anti-tumour immune response.

Severe hypoglycemia and ketoacidosis over one year in Italian pediatric population with type 1 diabetes mellitus: a multicenter retrospective observational study.

BACKGROUND AND AIMS: Evaluation of incidence and correlates of severe hypoglycemia (SH) and diabetes ketoacidosis (DKA) in children and adolescents with T1DM. METHODS AND RESULTS: Retrospective study conducted in 29 diabetes centers from November 2011 to April 2012. The incidence of SH and DKA episodes and their correlates were assessed through a questionnaire administered to parents of patients aged 0-18 years. Incidence rates and incident rate ratios (IRRs) were estimated through multivariate Poisson regression analysis and multilevel analysis. Overall, 2025 patients were included (age 12.4 ± 3.8 years; 53% males; diabetes duration 5.6 ± 3.5 years; HbA1c 7.9 ± 1.1%). The incidence of SH and DKA were of 7.7 and 2.4 events/100 py, respectively. The risk of SH was higher in females (IRR = 1.44; 95%CI 1.04-1.99), in patients using rapid acting analogues as compared to regular insulin (IRR = 1.48; 95%CI 0.97-2.26) and lower for patients using long acting analogues as compared to NPH insulin (IRR = 0.40; 95%CI 0.19-0.85). No correlations were found between SH and HbA1c levels. The risk of DKA was higher in patients using rapid acting analogues (IRR = 4.25; 95%CI 1.01-17.86) and increased with insulin units needed (IRR = 7.66; 95%CI 2.83-20.74) and HbA1c levels (IRR = 1.63; 95%CI 1.36-1.95). Mother's age was inversely associated with the risk of both SH (IRR = 0.95; 95%CI 0.92-0.98) and DKA (IRR = 0.94; 95%CI 0.88-0.99). When accounting for center effect, the risk of SH associated with the use of rapid acting insulin analogues was attenuated (IRR = 1.48; 95%CI 0.97-2.26); 33% and 16% of the residual variance in SH and DKA risk was explained by center effect. CONCLUSION: The risk of SH and DKA is mainly associated with treatment modalities and strongly depends on the practice of specialist centers.

Impact of a chronic care model based on patient empowerment on the management of Type 2 diabetes: effects of the SINERGIA programme.

AIMS: Several chronic care models for diabetes have been implemented in Italy, although conclusive data on their effectiveness are lacking. In the Cusano-Milanino diabetes clinic, patients with Type 2 diabetes with a stable disease/therapy (i.e. a steady level of HbA(1c) without need for therapy changes) are included in the SINERGIA programme: diabetologists, nurses and dietitians empower patients and telemedicine resources are utilized efficiently. METHODS: Clinical outcomes measured in the year before and after the initiation of SINERGIA were compared. A generalized hierarchical linear regression model for repeated measures was used. RESULTS: Altogether, 1004 patients were included; baseline characteristics were (mean ± sd): age 66.6 ± 6.2 years, 54.1% male, diabetes duration 10.8 ± 7.7 years, BMI 29.5 ± 4.8 kg/m(2) , HbA(1c) 6.9 ± 0.9% (52 ± 14 mmol/mol); 72.9% of patients were treated with anti-hypertensive drugs; 32.7% were treated with lipid-lowering drugs. After a median follow-up of 12 months (range 6-24 months), the proportion of patients with HbA(1c) ≤ 7.0% (≤ 53 mmol/mol) increased from 32.7 to 45.8% (P<0.0001), while those with HbA(1c) ≥9% (≥75 mmol/mol) decreased from 10.5 to 4.3% (P<0.0001). Patients with LDL cholesterol <100 mg/dl (<2.59 mmol/l) increased from 40 to 47% (P <0.0001), while those with LDL cholesterol ≥130 mg/dl (≥3.36 mmol/l) decreased from 26.6 to 19.7%; blood pressure levels were slightly improved. The mean number of face-to-face encounters decreased from (median and range) 2.8 (2.3-3.4) to 2.3 (1.9-2.7) (P<0.0001) visits per patient/year. CONCLUSIONS: The SINERGIA model is effective in improving metabolic control and major cardiovascular risk factors, while allowing diabetologists to dedicate more time to patients with more acute disease.

Four-year impact of a continuous quality improvement effort implemented by a network of diabetes outpatient clinics: the AMD-Annals initiative.

AIMS: We evaluated the impact of a continuous quality improvement effort implemented by a network of Italian diabetes clinics operating in the national healthcare system. METHODS: This was a controlled before-and-after study involving 95 centres, of which 67 joined the initiative since 2004 (group A) and 18 were first involved in 2007 (group B, control). All centres used electronic medical record systems. Information on quality indicators was extracted for the period 2004-2007. Data were centrally analysed anonymously and results were published annually. Each centre's performance was ranked against the 'best performers'. We compared quality indicators between the two groups of centres over 4 years. RESULTS: Over 100 000 Type 2 diabetes mellitus patients were evaluated annually. The proportion of patients with glycated haemoglobin levels < 7% increased by 6% in group A (2007-2004 difference) and by 1.3% in group B. The proportion of patients with low-density lipoprotein-cholesterol < 100 mg/dl improved by over 10% in both groups. The rate of patients with blood pressure values < or = 130/85 mmHg increased in group A (+6.4%), but not in group B (-1.4%). The use of insulin increased in group A only (+5.2%), while the use of statins increased by over 20% in both groups. CONCLUSIONS: A physician-led quality improvement effort, based on the systematic evaluation of routine data, is effective in improving the performance of a large number of diabetes clinics. The small percentage increase in the number of patients at target, if applied to large numbers of patients, would translate into a significant impact on public health.

Obesity and changes in urine albumin/creatinine ratio in patients with type 2 diabetes: the DEMAND study.

BACKGROUND AND AIMS: Obesity is a potential risk factor for renal disease in non-diabetic subjects. It remains unclear whether this also applies to diabetic patients. We investigated whether obesity predicted changes in albumin excretion rate in individuals with type 2 diabetes. METHODS AND RESULTS: Fifty Italian diabetes outpatient clinics enrolled a random sample of 1289 patients. A morning spot urine sample was collected to determine urinary albumin/creatinine ratio (ACR) at baseline and after 1 year from the study initiation. Progression of albumin excretion was defined as a doubling in ACR, while regression was defined as a 50% reduction. Multivariate logistic regression analyses were used to evaluate correlates of these outcomes. Data are expressed as odds ratios (OR) with 95% confidence intervals (CI). The risk of progression increased by 7% (OR=1.07; 95%CI 1.00-1.15) for every 5-cm increase in waist circumference measured at baseline, and by 17% (OR=1.17; 95%CI 1.03-1.33) for every one-unit increase in BMI during follow-up. The likelihood of regression was not independently associated with any of the variables investigated. The effect of obesity on progression of ACR was independent of metabolic control, blood pressure, treatment, and baseline level of albumin excretion. CONCLUSIONS: We found a tight link between obesity and changes in albumin excretion in diabetic subjects, suggesting potential benefits of interventions on body weight on end-organ renal damage.

Comments on shielding for dual energy accelerators.

Determination of shielding requirements for medical linear accelerators has been greatly facilitated by the publication of the National Council on Radiation Protection and Measurements (NCRP) latest guidelines on this subject in NCRP Report No. 151. In the present report the authors review their own recent experience with patient treatments on conventional dual energy linear accelerators to examine the various input parameters needed to follow the NCRP guidelines. Some discussion is included of workloads, occupancy, use factors, and field size, with the effects of intensity modulated radiotherapy (IMRT) treatments included. Studies of collimator settings showed average values of 13.1 x 16.2 cm2 for 6 MV and 14.1 x 16.8 cm2 for 18 MV conventional ports, and corresponding average unblocked areas of 228 and 254 cm2, respectively. With an average of 77% of the field area unblocked, this gives a mean irradiated area of 196 cm2 for the 18 MV beam, which dominates shielding considerations for most dual energy machines. Assuming conservatively small room dimensions, a gantry bin angle of 18 degrees was found to represent a reasonable unit for tabulation of use factors. For conventional 18 MV treatments it was found that the usual treatment angles of 0, 90, 180, and 270 degrees were still favored, and use factors of 0.25 represent reasonable estimates for these beams. As expected, the IMRT fields (all at 6 MV) showed a high degree of gantry angle randomization, with no bin having a use factor in excess of 0.10. It is concluded that unless a significant number of patients are treated with high energy IMRT, the traditional use factors of 0.25 are appropriate for the dominant high energy beam.

Decreased chemiluminescence in leukocyte adhesion deficiency presenting with recurrent sepsis, amoebiasis and Candida albicans urinary tract infection.

Leukocyte adhesion deficiency (LAD) is a rare disorder of cellular immunity, generally due to various mutations producing reduced or altered expression of membrane integrins. The authors report a case of LAD due to integrins expression imbalance. LAD was suspected after recurrent sepsis, fungal infection and amoebiasis with persistent leukocytosis. Neutrophils were studied with chemiluminescence showing decreased functional activity: up to now, this seems the first chemiluminescence study of neutrophil function and the first report of amoebiasis at the onset in LAD.

Self-monitoring of blood glucose in non-insulin-treated diabetic patients: a longitudinal evaluation of its impact on metabolic control.

AIMS: In the framework of a nationwide outcomes research programme, we assessed the impact of self-monitoring of blood glucose (SMBG) on metabolic control over 3 years in patients with Type 2 diabetes mellitus (DM2) not treated with insulin. METHODS: The study involved 1896 patients who completed, at 6-month intervals for 3 years, a questionnaire investigating SMBG practice. Clinical information was collected by participating clinicians at the same time intervals. The predictive value of SMBG frequency on long-term metabolic control was estimated using multilevel analysis. The impact of SMBG on metabolic control was also evaluated in distinct and homogeneous subgroups of patients showing different likelihood of performing SMBG, identified using a tree-growing technique (RECPAM). RESULTS: Overall, 22% of the patients were on diet alone and 78% were treated with oral agents; 41% practiced SMBG > or = 1/week (10.3% > or = 1/day). The analysis of metabolic control according to the frequency of SMBG failed to show any significant impact of this practice on HbA1c levels over 3 years. Similarly, changes in SMBG frequency during the study were not related to significant changes in HbA1c levels. RECPAM analysis led to the identification of eight classes, characterized by substantial differences in the likelihood of performing SMBG with a frequency of at least 1/week. Nevertheless, in none of the RECPAM classes identified, did SMBG predict a better metabolic control over 3 years of follow-up. In those RECPAM classes indicating that SMBG was mainly performed to avoid hypoglycaemic episodes, SMBG was associated with a decrease in the frequency of hypoglycaemic episodes during the study. CONCLUSIONS: In a large sample of non-insulin-treated Type 2 diabetic patients, the performance and frequency of SMBG did not predict better metabolic control over 3 years. We could not identify any specific subgroups of patients for whom SMBG practice was associated with lower HbA1c levels during the study.

Molecular characterization of human gastric mucosa by HR-MAS magnetic resonance spectroscopy.

The present study was aimed at identifying the molecular profile characteristic of the healthy human gastric mucosa. Ex vivo HR-MAS magnetic resonance spectroscopy performed at 9.4 Tesla (400.13 MHz for (1)H) on gastric specimens collected during endoscopy, permits the identification of more than forty species giving a detailed picture of the biochemical pattern of the gastric tissues. These preliminary data will be used for a comparison with gastric preneoplastic and neoplastic situations. Moreover, the full knowledge of the biochemical pattern of the healthy gastric tissues is the necessary presupposition for the application of magnetic resonance spectroscopy directly in vivo.