Improving Type 2 Diabetes Care with Extended-Release Metformin: Real-Life Insights from a Physician Educational Program.

BACKGROUND: Compared to Immediate-Release (IR) metformin, Extended-Release (ER) metformin reduces side effects and pill burden while improving adherence; however, there is little real-life data on patient satisfaction with this innovative formulation to guide physicians toward a more holistic approach. OBJECTIVE: Our goal is to train general practitioners on holistic patient management, with the aim of increasing patient satisfaction and treatment adherence, reducing side effects, and improving quality of life in patients with poor tolerance to metformin-IR. DESIGN AND METHODS: We designed an educational program for physicians called SlowDiab, aimed at establishing a holistic patient approach. In this context, adult patients with T2DM who experienced gastrointestinal discomfort with metformin-IR were enrolled and switched to metformin- ER. Data on glycemic control were collected at baseline and 2 months after switching. A survey was carried out on patients to assess their level of satisfaction. RESULTS: In 69 enrolled patients (mean [min-max] age, 68.2 [41-90]), side effects decreased after switching from 61.8% to 16.2% (p < 0.01), and the mean perceived burden of adverse events on a scale of 1 to 10 also decreased (6.17 vs. 3.82; p < 0.05). Among patients previously intolerant to metformin-IR, 74.3% reported no longer experiencing any side effects after the switch. The mean number of tablets taken daily (2.28 vs. 1.66; p < 0.01) and mean plasma glycated hemoglobin (HbA1c) values (7.0% vs. 6.7%; p < 0.05) decreased, while 93.8% of patients were satisfied with the treatment change. Moreover, 84.2% reported an improvement in glycemic control after the switch. CONCLUSION: In a real-life setting, an educational program for general practitioners confirmed that metformin ER reduces side effects and improves pill burden, therapeutic adherence, and patient satisfaction compared to metformin IR.

Critical evaluation of the questionnaires assessing adherence to the Mediterranean diet that are based on servings.

BACKGROUND AND AIMS: The Mediterranean Diet (MD) is characterized by a high intake of vegetables, fruit, legumes, nuts, and olive oil, and moderate fish, dairy, and wine intake. A high adherence to MD has been associated with numerous health benefits, including reduced risk of chronic diseases such as cardiovascular disease, cancer, and type 2 diabetes. The clinical assessment of MD adherence is complicated by the absence of a univocally accepted tool and by the abundance of questionnaires developed to determine adherence, whose reliability and validity is uncertain. In this inter-associative document, we critically evaluated servings-based questionnaires for the assessment of MD adherence, aiming to identify the most valuable tool for the use in clinical practice. METHODS AND RESULTS: For each questionnaire, we analyzed the structure, evidence on health-related outcomes and agreement with the recommendations of MD. We found that most questionnaires do not accurately reflect the principles of MD in terms of the food groups and their optimal consumption frequency. Additionally, the comparison of questionnaires revealed low agreement and some concerns with regard to the scoring assumptions. CONCLUSIONS: Among the available questionnaires, we suggest the use of the 15-Items Pyramid based Mediterranean Diet Score (PyrMDS), which is the one with fewer flaws and a strong supporting body of theoretical and scientific evidence. The use of the PyrMDS may facilitate the assessment of MD adherence in clinical practice, which is instrumental in reducing the risk of non-communicable chronic diseases.

Effects of polyphenols on cardio-metabolic risk factors and risk of type 2 diabetes. A joint position statement of the Diabetes and Nutrition Study Group of the Italian Society of Diabetology (SID), the Italian Association of Dietetics and Clinical Nutrition (ADI) and the Italian Association of Medical Diabetologists (AMD).

AIM: A large body of evidence supports a role of polyphenols in the prevention of chronic diseases, i.e. type 2 diabetes (DMT2), cardiovascular diseases and some types of cancer. In the present manuscript, the effect of polyphenol/phenolic compounds on the main cardio-metabolic risk factors (body weight, blood pressure, blood glucose concentrations, plasma lipids, inflammation and oxidative stress) in humans will be discussed. DATA SYNTHESIS: Epidemiological evidence supports the beneficial effects of polyphenol-rich diets in the prevention of T2D risk. However, the available evidence from randomized controlled clinical trials did not allow the identification of specific phenolic compounds or polyphenol-rich foods that effectively improve cardio-metabolic risk factors. The most promising results in terms of the management of cardio-metabolic risk factors derive from RCTs based on a long-term intake of polyphenol-rich foods and beverages. Therefore, future studies should focus on a diet containing different classes of polyphenols rather than a specific food or phenolic compound. The hypothesis is that a polyphenol-rich diet may have a pleiotropic effect on cardiometabolic risk factors thanks to the specific action of different polyphenol subclasses. CONCLUSION: The lack of conclusive evidence on the effectiveness of polyphenols in the management of cardio-metabolic risk factors does not allow recommendation of their use as supplements to reduce T2D and CVD risk. However, the daily consumption of naturally polyphenol-rich foods and beverages might be advised according to the current nutritional dietary recommendation.

Cow's Milk Consumption and Health: A Health Professional's Guide.

The most recent scientific evidence supports the consumption of cow's milk and dairy products as part of a balanced diet. However, these days, the public and practicing physicans are exposed to a stream of inconsistent (and often misleading) information regarding the relationship between cow's milk intake and health in the lay press and in the media. The purpose of this article, in this context, is to facilitate doctor-patient communication on this topic, providing physicians with a series of structured answers to frequently asked patient questions. The answers range from milk and milk-derived products' nutritional function across the life span, to their relationship with diseases such as osteoporosis and cancer, to lactose intolerance and milk allergy, and have been prepared by a panel of experts from the Italian medical and nutritional scientific community. When consumed according to appropriate national guidelines, milk and its derivatives contribute essential micro- and macronutrients to the diet, especially in infancy and childhood where bone mass growth is in a critical phase. Furthermore, preliminary evidence suggests potentially protective effects of milk against overweight, obesity, diabetes, and cardiovascular disease, while no clear data suggest a significant association between milk intake and cancer. Overall, current scientific literature suggests that an appropriate consumption of milk and its derivatives, according to available nutritional guidelines, may be beneficial across all age groups, with the exception of specific medical conditions such as lactose intolerance or milk protein allergy. Key teaching points: Milk and its derivatives contribute essential micro and macronutrients to the diet, when consumed according to appropriate national guidelines, especially in infancy and childhood where bone mass growth is in a critical phase. Preliminary evidence suggests potentially protective effects of milk against overweight, obesity, diabetes and cardiovascular disease No clear data are available about the association between milk intake and cancer. Current scientific literature suggests that an appropriate consumption of milk and its derivatives may be beneficial at all ages, with the exception of specific medical conditions such as lactose intolerance or milk protein allergy.

Efficacy, safety and acceptability of the new pen needle 34G × 3.5 mm: a crossover randomized non-inferiority trial; AGO 02 study.

OBJECTIVE: Insulin injection aspects, such as fear of injection and pain, directly affect glycemic control, patient adherence and quality of life. Use of thinner and shorter needles could increase acceptance of injections. The aim of the study is to evaluate the non-inferiority of the new 34G × 3.5 mm needle compared to a 32G × 4 mm in patients with diabetes treated with insulin. METHODS: This is an open, randomized, two-period crossover, non-inferiority trial. Every treatment period lasted 3 weeks. Patients with type 1 or type 2 diabetes, treated with multiple daily insulin injections, were randomly assigned to receive a 34G × 3.5 mm or a 32G × 4 mm pen needle. The primary endpoint was the non-inferiority of the 34G × 3.5 mm in comparison with the 32G × 4 mm pen needle in terms of percentage absolute change of blood fructosamine (% |ΔFru|), using a non-inferiority margin of 20%. RESULTS: Overall 77 patients were randomized and 73 completed the study. Patients characteristics were: 52% male, 80.5% affected by type 1 diabetes, mean age 52 years (±14.6), mean BMI 24.5 kg/m2 (±5.6), HbA1c 8% (±1.1) and baseline fructosamine level 350 µmol/l (±84). Mean fructosamine levels increased by 0.56 µmol/l with the 34G needle, while a reduction of 7.29 µmol/l was documented with the 32G needle. The difference between the two groups (7.84 µmol/l) was not statistically significant (p = .27). The % |ΔFru| between the two groups was 7.55% (95% CI 5.67-9.44), meeting the non-inferiority criterion. Glycemic variability, expressed as standard deviation of fasting blood glucose and post-prandial glucose, was not different between the two treatment groups (p = .63 and p = .77, respectively). CONCLUSIONS: The 34G × 3.5 mm needle was non-inferior to the 32G × 4 mm needle regarding fructosamine levels and glycemic variability supporting the suitability of the 34G × 3.5 mm needle for insulin injection in patients with diabetes. CLINICAL TRIAL REGISTRATION: NCT02690467.

Nutraceuticals and functional foods for the control of plasma cholesterol levels. An intersociety position paper.

Current evidence shows that cholesterol management either reduces the likelihood of cardiovascular disease (CVD) or slows down its progression. Hence, it is important that all health professionals make appropriate use of all the available intervention strategies to control risk factors: from dietary improvement and positive lifestyle changes to the use of functional foods, food supplements, and drugs. This review examines the effect of the most frequently occurring cholesterol-lowering substances in functional foods or in supplements across Europe, namely plant sterols and stanols, monacolin K found in red yeast rice, berberine and beta-glucans. We conclude that currently available supplements and functional foods can effectively reduce plasma LDL cholesterol levels by about 5 to 25%, either alone or in combination. Suitable candidates for these products are mainly individuals at low absolute cardiovascular risk at a young age or according to classic algorithms. Of note, despite being freely available for purchase, these products should be used following shared agreement between the physician and the patient ("concordance").

Palm oil and human health. Meeting report of NFI: Nutrition Foundation of Italy symposium.

The use of palm oil by the food industry is increasingly criticized, especially in Italy, for its purported negative effects on human health and environment. This paper summarizes the conclusions of a Symposium on this topic, gathered by the Nutrition Foundation of Italy, among experts representing a number of Italian Medical and Nutritional Scientific Societies. Toxicological and environmental issues were not considered. Participants agreed that: no evidence does exist on the specific health effects of palm oil consumption as compared to other saturated fatty acids-rich fats; the stereospecific distribution of saturated fatty acids in the triacylglycerol molecule of palm oil limits their absorption rate and metabolic effects; in agreement with International guidelines, saturated fatty acids intake should be kept <10% of total energy, within a balanced diet; within these limits, no effect of palm oil consumption on human health (and specifically on CVD or cancer risk) can be foreseen.

Effectiveness, safety and feasibility of an evidence-based insulin infusion protocol targeting moderate glycaemic control in intensive cardiac care units.

OBJECTIVES: To assess the effectiveness, safety and feasibility of the revised, simplified nurse-managed version of our insulin infusion protocol, adapted to the new recommended glycaemic target of 140 to 180 mg/dL (Desio Diabetes Diagram i.v. 140-180). METHODS: All clinical responses to the Desio Diabetes Diagram i.v. 140-180 in use for 3 years were recorded in patients with diabetes or hyperglycaemia admitted to our intensive cardiac care unit. To assess the feasibility, we asked nurses to complete an ad hoc questionnaire anonymously when the new insulin infusion protocol had been in use for 2 years. RESULTS: From December 2010 to December 2013, 276 patients (173 men, median age 75 years) were treated according to the Desio Diabetes Diagram i.v. 140-180. The median time to reach glycaemic target was 4 h (Q1-Q3 2-8) in 128 patients with blood glucose >180 mg/dL and 2 h (Q1-Q3 1-4) in 82 patients with blood glucose <140 mg/dL. Once the target had been reached, insulin infusion was maintained for a median of 38 h (Q1-Q3 24-48) with blood glucose between 140 and 180 mg/dL for 58.3% of the infusion time. Over a total of 11,863 h of infusion, seven blood glucose <70 mg/dL occurred. The Desio Diabetes Diagram i.v. 140-180 protocol was considered easy to use by 93% of nurses. CONCLUSIONS: The Desio Diabetes Diagram i.v. 140-180 protocol, fully managed by nurses, with insulin and glucose intravenous infusion proved effective, safe and feasible in maintaining blood glucose between 140 and 180 mg/dL in patients with diabetes or hyperglycaemia admitted to the intensive cardiac care unit for acute cardiac events.

Effectiveness of a nurse-managed protocol to prevent hypoglycemia in hospitalized patients with diabetes.

BACKGROUND: Hypoglycemia due to inadequate carbohydrate intake is a frequent complication of insulin treatment of diabetic in-patients. Objective. To assess the effectiveness of a nurse-managed protocol to prevent hypoglycemia during subcutaneous insulin treatment. DESIGN: Prospective pre-post-intervention study. METHODS: In 350 consecutive diabetic in-patients the incidence of hypoglycemia (blood glucose < 70 mg/dL) during subcutaneous insulin treatment was assessed before (phase A) and after (phase B) the protocol was adopted to permit (1) the patient to opt for substitutive food to integrate incomplete carbohydrate intake in the meal; (2) in case of lack of appetite or repeatedly partial intake of the planned food, prandial insulin administered at the end of the meal to be related to the actual amount of carbohydrates eaten; (3) intravenous infusion of glucose during prolonged fasting. RESULTS: Eighty-four patients in phase A and 266 in phase B received subcutaneous insulin for median periods of, respectively, 7 (Q1-Q3 6-12) and 6 days (Q1-Q3 4-9). Hypoglycemic events declined significantly from 0.34 ± 0.33 per day in phase A to 0.19 ± 0.30 in phase B (P > 0.001). CONCLUSIONS: A nurse-managed protocol focusing on carbohydrate intake reduced the incidence of hypoglycemia in patients with diabetes receiving subcutaneous insulin in hospital.

Changes in prescribing patterns and clinical outcomes in elderly diabetic patients in 2000 and 2010: analysis of a large Italian population-based study.

PURPOSE: To describe prescribing patterns in elderly Italian diabetic patients of the Lombardy Region in 2000 and 2010 using an administrative database. Hospital admissions and mortality were also recorded and compared in the two index years. METHODS: Analyses were performed on the whole cohort of elderly diabetic patients and across age groups. Direct age standardization was done, with data from the Lombardy Region database for 2005 used as reference to compare diabetic populations in the two index years. Logistic regression models were used to analyze changes in hospital admissions and mortality and to calculate odds ratios. RESULTS: Using data retrieved from the Lombardy Region database we identified 176,384 and 283,982 elderly diabetic patients in 2000 and 2010, respectively. The overall rates of patients treated with antidiabetic drugs were 92.5% in 2000 and 97.0% in 2010. Between 2000 and 2010 the prescribing of glibenclamide declined by 30.0% (from 52.9 to 22.9%, p < 0.001) and that of biguanides rose by 17.4 % (from 47.5 to 64.8%, p < 0.001). In 2010 thiazolidinediones, dipeptidyl peptidase-4 inhibitors and incretin mimetic drugs were seldom prescribed. Drugs for cardiovascular prevention rose in all age classes from 2000 to 2010, and the rates of hospital admission overall fell from 32.0 to 26.8% (p < 0.001) during the same period, with the exception of those aged ≥85 years. Between 2000 and 2010 the mortality rate decreased in patients aged 65-74 years (from 3.4 to 2.9%, p < 0.0001) and rose significantly in those aged ≥85 years. CONCLUSIONS: The drug prescription profile of elderly diabetic patients changed from 2000 to 2010, with a tendency toward recommended drugs. These changes may possibly be linked to the decrease in both hospital admissions and mortality in the diabetic group aged 65-74 years.

Transition from intravenous to subcutaneous insulin: effectiveness and safety of a standardized protocol and predictors of outcome in patients with acute coronary syndrome.

OBJECTIVE: The study objectives were 1) to assess the effectiveness and safety of a standardized protocol for the transition to subcutaneous insulin and oral feeding in diabetic or hyperglycemic patients with acute coronary syndrome (ACS) who were receiving intravenous insulin and glucose at the time of the transfer from the intensive cardiac care unit to a general ward and 2) to identify predictors of transition outcome. RESEARCH DESIGN AND METHODS: This was a prospective observational study. The protocol specifies that patients receive a 100% of their daily subcutaneous insulin requirement from the first day of oral feeding, calculated from the intravenous insulin rate during the final 12 h divided into two: 50% basal and 50% prandial. RESULTS: In 142 patients (93 male, 49 female, age range 47-88 years, 135 with known diabetes) the first day after transition, 44.8% of blood glucose (BG) measurements were within the strict range of 100-140 mg/dL before meals and 100-180 mg/dL after meals, and 70.8% were within the broader ranges of 80-160 mg/dL and 80-200 mg/dL, respectively. Pre- or postprandial hypoglycemia (BG<70 mg/dL) occurred in 11 patients (7.7%) on the first day and in 38 patients (26.8%) on the first 3 days after transition. Old age, high doses of intravenous insulin, and wide BG variations in the 24 h before insulin infusion was stopped were predictive of poor BG control after transition. CONCLUSIONS: This study shows the effectiveness and safety of a standardized protocol for the transition from intravenous to subcutaneous insulin in patients with ACS when regular oral feeding was resumed.

Interactive diary for diabetes: A useful and easy-to-use new telemedicine system to support the decision-making process in type 1 diabetes.

BACKGROUND: Widespread use of carbohydrate (CHO) counting is limited by its complex educational needs, but a telemedicine system could simplify the patients' training. METHODS: The Diabetes Interactive Diary (DID) was set up on patients' mobile phones and allowed to record the blood glucose values and quantify the total CHO intake during a meal, by choosing the specific food and the amount ingested from a list of pictures. It also suggested the most appropriate insulin bolus in relation to the patient's CHO/insulin ratio. Data were sent to the physician by Short Message Service (also known as text message). Two pilot studies were carried out to investigate the feasibility and acceptability of the system and its effectiveness in improving metabolic control. RESULTS: In the first study, 50 patients were involved in a survey with questionnaires administered before and 12 weeks after the start of the DID. The system was considered by almost all the patients as easy to use and very helpful. CHO counting and insulin bolus calculation were ranked as the most useful functions. In the second study, 41 consecutive patients using DID under routine clinical practice conditions were evaluated after a median of 9 months of follow-up. DID was associated with a nonstatistically significant reduction in fasting blood glucose (FBG), postprandial glucose (PPG), and hemoglobin A1c levels. FBG and PPG coefficient of variation (CV) values were significantly reduced: FBG-CV decreased by 6.7% (95% confidence interval -11.9, -1.6; P = 0.02), while PPG-CV decreased by 11.5% (95% confidence interval -19.3, -3.7; P = 0.01). No patients reported serious hypoglycemic episodes requiring medical intervention. CONCLUSIONS: DID can represent a useful, safe, and easy-to-use tool to help the patient with type 1 diabetes promote dietary freedom. Adjustment of insulin doses according to CHO intake allowed the reduction of glucose variability, increasingly recognized as an important, independent risk factor for cardiovascular events.

Hyperglycemia during acute coronary syndrome: a nurse-managed insulin infusion protocol for stricter and safer control.

BACKGROUND: Diabetic patients with acute coronary syndromes (ACS) might benefit from tight glycemic control by means of insulin infusion. Nurse-implemented insulin infusion protocols (IIP) are available but none validated in patients with ACS admitted to a coronary care unit (CCU). AIMS: To assess feasibility, effectiveness and safety of a new nurse-managed IIP (Desio Diabetes Diagram, DDD) for intensive glucose control in patients with suspected ACS and known diabetes or blood glucose (BG) >200 mg/dL. METHODS AND RESULTS: To reach and maintain a target BG level of 100-139 mg/dL we adopted a nomogram based on the percent changes in the insulin infusion rate according to the current BG value and the percent change from previous BG level. Ninety-one consecutive patients (53 men, mean age 69.7+/-11.2 years) were treated with DDD IIP. Baseline BG was 202.2+/-86.8 mg/dL. The median time to achieve the target was 3 h (Q1-Q3 2-5 h). Afterwards target BG levels were maintained for 70.4+/-15.9% of the time. During 5004 h of insulin infusion BG never fell below 40 mg/dL. CONCLUSIONS: The nurse-managed DDD IIP was easily implemented in our CCU and permitted strict and safe glycemic control in hyperglycemic patients with ACS.