Efficacy and durability of multifactorial intervention on mortality and MACEs:a randomized clinical trial in type-2 diabetic kidney disease

Background: Multiple modifiable risk factors for late complications in patients with diabetic kidney disease (DKD), including hyperglycemia, hypertension and dyslipidemia, increase the risk of a poor outcome. DKD is associated with a very high cardiovascular risk, which requires simultaneous treatment of these risk factors by implementing an intensified multifactorial treatment approach. However, the efficacy of a multifactorial intervention on major fatal/non-fatal cardiovascular events (MACEs) in DKD patients has been poorly investigated. Methods: Nephropathy in Diabetes type 2 (NID-2) study is a multicentre, cluster-randomized, open-label clinical trial enrolling 395 DKD patients with albuminuria, diabetic retinopathy (DR) and negative history of CV events in 14 Italian diabetology clinics. Centres were randomly assigned to either Standard-of-Care (SoC) (n = 188) or multifactorial intensive therapy (MT, n = 207) of main cardiovascular risk factors (blood pressure 40/50 mg/dL for men/women and < 175 mg/dL, respectively). Primary endpoint was MACEs occurrence by end of follow-up phase. Secondary endpoints included single components of primary endpoint and all-cause death. Results: At the end of intervention period (median 3.84 and 3.40 years in MT and SoC group, respectively), targets achievement was significantly higher in MT. During 13.0 years (IQR 12.4–13.3) of follow-up, 262 MACEs were recorded (116 in MT vs. 146 in SoC). The adjusted Cox shared-frailty model demonstrated 53% lower risk of MACEs in MT arm (adjusted HR 0.47, 95%CI 0.30–0.74, P = 0.001). Similarly, all-cause death risk was 47% lower (adjusted HR 0.53, 95%CI 0.29–0.93, P = 0.027). Conclusion: MT induces a remarkable benefit on the risk of MACEs and mortality in high-risk DKD patients. Clinical Trial Registration ClinicalTrials.gov number, NCT00535925. https://clinicaltrials.gov/ct2/show/NCT0053592

Optimizing insulin glargine plus one injection of insulin glulisine in type 2 diabetes in the ELEONOR study: similar effects of telecare and conventional self-monitoring of blood glucose on patient functional health status and treatment satisfaction.

OBJECTIVE: To determine the functional health status and treatment satisfaction in patients with type 2 diabetes from the Evaluation of Lantus Effect ON Optimization of use of single dose Rapid insulin (ELEONOR) study that investigated whether a telecare program helps optimization of basal insulin glargine with one bolus injection of insulin glulisine. RESEARCH DESIGN AND METHODS: Functional health status and treatment satisfaction were investigated using the 36-Item Short-Form (SF-36) Health Survey, the World Health Organization Well-Being Questionnaire (WBQ), and the Diabetes Treatment Satisfaction Questionnaire. RESULTS: Of 291 randomized patients, 238 completed the study (telecare: 114; self-monitoring blood glucose: 124). Significant improvements were detected in most SF-36 domains, in WBQ depression and anxiety scores, and in treatment satisfaction, without differences between study groups. CONCLUSIONS: An insulin regimen that substantially improves metabolic control, while minimizing the risk of hypoglycemia, can positively affect physical and psychologic well-being and treatment satisfaction irrespective of the educational support system used

Telecare Provides comparable efficacy to conventional self-monitored blood glucose in patients with type 2 diabetes titrating one injection of insulin glulisine-the ELEONOR study.

BACKGROUND: We compared telecare and conventional self-monitored blood glucose (SMBG) programs for titrating the addition of one bolus injection of insulin glulisine in patients with type 2 diabetes uncontrolled on oral hypoglycemic agents for ≥3 months who were first titrated with basal insulin glargine. METHODS: This randomized, multicenter, parallel-group study included 241 patients (mean screening glycosylated hemoglobin [HbA(1c)], 8.8% [73 mmol/mol]). In the run-in phase, any antidiabetes medication, except for metformin, was discontinued. Metformin was then up-titrated to 2 g/day (1 g twice daily) until study completion. Following run-in, all patients started glargine for 8-16 weeks, targeting fasting plasma glucose (FPG) ≤5.6 mmol/L using conventional SMBG. Patients with FPG ≤7 mmol/L added a glulisine dose at the meal with the highest postprandial plasma glucose excursion, titrated to target 2-h postprandial plasma glucose level &lt;7.8 mmol/L using telecare or SMBG for 24 weeks. Patients with FPG &gt;7 mmol/L at week 16 were withdrawn from the study. RESULTS: After glargine titration, 224 patients achieved FPG ≤7 mmol/L, without any difference between telecare and SBMG groups (mean±SD, 6.2±0.8 vs. 6.0±0. 9 mmol/L, respectively). HbA(1c) levels were lower following titration and were similar for telecare and SMBG (7.9±0.9% vs. 7.8±0.9% [63 vs. 62 mmol/mol], respectively). Adding glulisine further reduced HbA(1c) in both groups (-0.7% vs. -0.7%); 45.2% and 54.8% (P=0.14), respectively, of patients achieved HbA(1c) ≤7.0% (≤53 mmol/mol). Weight change and hypoglycemia were similar between groups. CONCLUSIONS: Patients adding one dose of glulisine at the meal with the highest postprandial plasma glucose excursion to titrated basal glargine achieved comparable improvements in glycemic control irrespective of traditional or telecare blood glucose monitoring

Telecare Provides comparable efficacy to conventional self-monitored blood glucose in patients with type 2 diabetes titrating one injection of insulin glulisine-the ELEONOR study.

BACKGROUND: We compared telecare and conventional self-monitored blood glucose (SMBG) programs for titrating the addition of one bolus injection of insulin glulisine in patients with type 2 diabetes uncontrolled on oral hypoglycemic agents for ≥3 months who were first titrated with basal insulin glargine. METHODS: This randomized, multicenter, parallel-group study included 241 patients (mean screening glycosylated hemoglobin [HbA(1c)], 8.8% [73 mmol/mol]). In the run-in phase, any antidiabetes medication, except for metformin, was discontinued. Metformin was then up-titrated to 2 g/day (1 g twice daily) until study completion. Following run-in, all patients started glargine for 8-16 weeks, targeting fasting plasma glucose (FPG) ≤5.6 mmol/L using conventional SMBG. Patients with FPG ≤7 mmol/L added a glulisine dose at the meal with the highest postprandial plasma glucose excursion, titrated to target 2-h postprandial plasma glucose level &lt;7.8 mmol/L using telecare or SMBG for 24 weeks. Patients with FPG &gt;7 mmol/L at week 16 were withdrawn from the study. RESULTS: After glargine titration, 224 patients achieved FPG ≤7 mmol/L, without any difference between telecare and SBMG groups (mean±SD, 6.2±0.8 vs. 6.0±0. 9 mmol/L, respectively). HbA(1c) levels were lower following titration and were similar for telecare and SMBG (7.9±0.9% vs. 7.8±0.9% [63 vs. 62 mmol/mol], respectively). Adding glulisine further reduced HbA(1c) in both groups (-0.7% vs. -0.7%); 45.2% and 54.8% (P=0.14), respectively, of patients achieved HbA(1c) ≤7.0% (≤53 mmol/mol). Weight change and hypoglycemia were similar between groups. CONCLUSIONS: Patients adding one dose of glulisine at the meal with the highest postprandial plasma glucose excursion to titrated basal glargine achieved comparable improvements in glycemic control irrespective of traditional or telecare blood glucose monitoring

Abitudini alimentari dei pazienti con diabete di tipo 2: Impatto delle tradizioni gastronomiche regionali. Uno studio di popolazione

Despite all efforts, nutritional guidelines for people with diabetes are still not widely applied in clinical practice. Among the various possible reasons, there is the fact that eating habits are greatly influenced by local traditions. We investigated the dietary habits of diabetic patients from Northern, Central and Southern Italy, to see to what extent local gastronomic habits affect compliance with nutritional recommendations. We studied 1786 patients with type 2 diabetes, whose habitual diet was assessed using a validated food frequency questionnaire (EPIC - European Prospective Investi - gation on Cancer and Nutrition). The energy intake was similar in the three areas, but the consumption of total lipids, saturated and polyunsaturated fatty acids was significantly lower in Southern and Central Italy than in the Northern regions (p < 0.05). In contrast, the consumption of total carbohydrates and fiber was higher in Southern and Central Italy than in the North (p < 0.05). Higher intake of meat, salami and animal fats in Northern Italy accounted for the differences in fat intake. For carbohydrates and fiber the difference was explained by the higher intake of wholemeal bread and pulses in Southern Italy. Compliance with dietary recommendations was generally unsatisfactory. Consumption of saturated fatty acids was higher than recommended, and fiber intake much lower. In conclusion, dietary recommendations are poorly observed by patients with type 2 diabetes throughout the country, and eating habits are significantly influenced by the local gastronomic background. This is important for identifying educational measures aimed at improving adherence to nutritional guidelines

Abitudini alimentari dei pazienti con diabete di tipo 2: Impatto delle tradizioni gastronomiche regionali. Uno studio di popolazione

Despite all efforts, nutritional guidelines for people with diabetes are still not widely applied in clinical practice. Among the various possible reasons, there is the fact that eating habits are greatly influenced by local traditions. We investigated the dietary habits of diabetic patients from Northern, Central and Southern Italy, to see to what extent local gastronomic habits affect compliance with nutritional recommendations. We studied 1786 patients with type 2 diabetes, whose habitual diet was assessed using a validated food frequency questionnaire (EPIC - European Prospective Investi - gation on Cancer and Nutrition). The energy intake was similar in the three areas, but the consumption of total lipids, saturated and polyunsaturated fatty acids was significantly lower in Southern and Central Italy than in the Northern regions (p < 0.05). In contrast, the consumption of total carbohydrates and fiber was higher in Southern and Central Italy than in the North (p < 0.05). Higher intake of meat, salami and animal fats in Northern Italy accounted for the differences in fat intake. For carbohydrates and fiber the difference was explained by the higher intake of wholemeal bread and pulses in Southern Italy. Compliance with dietary recommendations was generally unsatisfactory. Consumption of saturated fatty acids was higher than recommended, and fiber intake much lower. In conclusion, dietary recommendations are poorly observed by patients with type 2 diabetes throughout the country, and eating habits are significantly influenced by the local gastronomic background. This is important for identifying educational measures aimed at improving adherence to nutritional guidelines