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Improved Glucose Profile in Patients With Type 2 Diabetes With a New, High-Protein, Diabetes-Specific Tube Feed During 4 Hours of Continuous Feeding.
Lansink, M, Hofman, Z, Genovese, S, Rouws, CHFC, Ceriello, A
JPEN. Journal of parenteral and enteral nutrition. 2017;(6):968-975
Abstract
BACKGROUND Hyperglycemia frequently occurs in hospitalized patients receiving nutrition support. In this study, the effects of a new diabetes-specific formula (DSF) on glucose profile during 4 hours of continuous feeding and 4 hours after stopping feeding were compared with a standard formula (SF). MATERIALS AND METHODS In this randomized, controlled, double-blind, crossover study, ambulant, nonhospitalized patients with type 2 diabetes received the DSF or an isocaloric, fiber-containing SF via a nasogastric tube. After overnight fasting, the formula was continuously administered to the patients during 4 hours. Plasma glucose and insulin concentrations were determined during the 4-hour period and in the subsequent 4 hours during which no formula was provided. RESULTS During the 4-hour feeding period, DSF compared with SF resulted in a lower mean delta glucose concentration in the 3- to 4-hour period (0.3 ± 1.0 and 2.4 ± 1.5 mmol/L; P < .001). Also, the (delta) peak concentrations, (delta) mean concentrations, and incremental area under the curve (iAUC) for glucose and insulin were significantly lower during DSF compared with SF feeding (all comparisons: P < .001). Furthermore, fewer patients experienced hyperglycemia (>10 mmol/L) on DSF compared with SF (2 vs 11, P = .003, respectively). No differences in number of patients with hypoglycemia (<3.9 mmol/L) were observed. No significant differences in tolerance were observed. CONCLUSION Administration of a new, high-protein DSF during 4 hours of continuous feeding resulted in lower glucose and insulin levels compared with a fiber-containing SF in ambulant, nonhospitalized patients with type 2 diabetes. These data suggest that a DSF may contribute to lower glucose levels in these patients.
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Lispro insulin in people with non-alcoholic liver cirrhosis and type 2 diabetes mellitus.
Gentile, S, Guarino, G, Strollo, F, Romano, M, Genovese, S, Masarone, M, Ceriello, A
Diabetes research and clinical practice. 2016;:179-86
Abstract
AIMS: To compare metabolic control under lispro and recombinant regular human insulin (RHI) in people with diet-unresponsive type 2 diabetes mellitus (T2DM) and compensated non-alcoholic liver disease (CLD).
METHODS 108 people with T2DM and CLD were randomly allocated to RHI or lispro according to a 12+12 week cross-over protocol. A 1-week continuous glucose monitoring (CGM) session was performed at the end of each treatment period followed by a standard meal test with a 12IU lispro or RHI shot ahead.
RESULTS CGM showed higher glycemic excursions under RHI than under lispro (p<0.01) with lower glucose levels in the late post-absorption phase (p<0.05) and even more during the night (p<0.01). Post-challenge incremental areas under the curve (ΔAUC) were undistinguishable for insulin but lower for glucose, while insulin peaked higher and earlier and glycemic excursions were lower with lispro than with RHI (0.05
CONCLUSIONS Lispro granted lower early postprandial glucose levels and late postprandial hypoglycemic rates and therefore might represent the treatment of choice for people with T2DM and compensated CLD. This might depend on its faster/shorter-living effects, as well as, on the lower liver glucose output expected from its earlier hepatic distribution.
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Prospective, randomized trial on intensive SMBG management added value in non-insulin-treated T2DM patients (PRISMA): a study to determine the effect of a structured SMBG intervention.
Scavini, M, Bosi, E, Ceriello, A, Giorgino, F, Porta, M, Tiengo, A, Vespasiani, G, Bottalico, D, Marino, R, Parkin, C, et al
Acta diabetologica. 2013;(5):663-72
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Abstract
Self-monitoring of blood glucose (SMBG) is a core component of diabetes management. However, the International Diabetes Federation recommends that SMBG be performed in a structured manner and that the data are accurately interpreted and used to take appropriate therapeutic actions. We designed a study to evaluate the impact of structured SMBG on glycemic control in non-insulin-treated type 2 diabetes (T2DM) patients. The Prospective, Randomized Trial on Intensive SMBG Management Added Value in Non-insulin-Treated T2DM Patients (PRISMA) is a 12-month, prospective, multicenter, open, parallel group, randomized, and controlled trial to evaluate the added value of an intensive, structured SMBG regimen in T2DM patients treated with oral agents and/or diet. One thousand patients (500 per arm) will be enrolled at 39 clinical sites in Italy. Eligible patients will be randomized to the intensive structured monitoring (ISM) group or the active control (AC) group, with a glycosylated hemoglobin (HbA1c) target of <7.0%. Intervention will comprise (1) structured SMBG (4-point daily glucose profiles on 3 days per week [ISM]; discretionary, unstructured SMBG [AC]); (2) comprehensive patient education (both groups); and (3) clinician's adjustment of diabetes medications using an algorithm targeting SMBG levels, HbA1c and hypoglycemia (ISM) or HbA1c and hypoglycemia (AC). The intervention and trial design build upon previous research by emphasizing appropriate and collaborative use of SMBG by both patients and physicians. Utilization of per protocol and intent-to-treat analyses facilitates assessment of the intervention. Inclusion of multiple dependent variables allows us to assess the broader impact of the intervention, including changes in patient and physician attitudes and behaviors.
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Post hoc subgroup analysis of the HEART2D trial demonstrates lower cardiovascular risk in older patients targeting postprandial versus fasting/premeal glycemia.
Raz, I, Ceriello, A, Wilson, PW, Battioui, C, Su, EW, Kerr, L, Jones, CA, Milicevic, Z, Jacober, SJ
Diabetes care. 2011;(7):1511-3
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Abstract
OBJECTIVE To identify the Hyperglycemia and Its Effect After Acute Myocardial Infarction on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus (HEART2D) trial subgroups with treatment difference. RESEARCH DESIGN AND METHODS In 1,115 type 2 diabetic patients who had suffered from an acute myocardial infarction (AMI), the HEART2D trial compared two insulin strategies targeting postprandial or fasting/premeal glycemia on time until first cardiovascular event (cardiovascular death, nonfatal MI, nonfatal stroke, coronary revascularization, or hospitalization for acute coronary syndrome). The HEART2D trial ended prematurely for futility. We used the classification and regression tree (CART) to identify baseline subgroups with potential treatment differences. RESULTS CART estimated the age of >65.7 years to best predict the difference in time to first event. In the subgroup aged>65.7 years (prandial, n=189; basal, n=210), prandial patients had a significantly longer time to first event and a lower proportion experienced a first event (n=56 [29.6%] vs. n=85 [40.5%]; hazard ratio 0.69 [95% CI 0.49-0.96]; P=0.029), despite similar A1C levels. CONCLUSIONS Older type 2 diabetic AMI survivors may have a lower risk for a subsequent cardiovascular event with insulin targeting postprandial versus fasting/premeal glycemia.
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Administration of a new diabetes-specific enteral formula results in an improved 24h glucose profile in type 2 diabetic patients.
Ceriello, A, Lansink, M, Rouws, CH, van Laere, KM, Frost, GS
Diabetes research and clinical practice. 2009;(3):259-66
Abstract
AIMS: Study the effect of several boluses of a new diabetes-specific formula (DSF) during the day on 24h glucose profile. METHODS In this randomized, controlled, double-blind, cross-over study 12 ambulatory type 2 diabetic patients were included. Subjects received a new DSF and an isocaloric standard fibre-containing formula (SF) while continuing their anti-diabetic medication. Subjects received 100% of their calculated daily energy requirements as bolus feeding every 3h (5 times/day, starting at 8.00 a.m.+/-1h). RESULTS Glucose profiles were significantly better after administration of DSF compared with SF determined as mean glucose concentration (+/-SEM) (8.7+/-0.5 versus 9.6+/-0.6 mmol/L, p<0.05 during 24h; 9.4+/-0.6 versus 10.7+/-0.6 mmol/L, p<0.001 during daytime) or as incremental area under the curve during daytime (-44%; p<0.05). Subjects receiving DSF experienced less hyperglycaemic time over 24h (-26%; p<0.05) and during daytime (-30%; p<0.05). Furthermore, lower individual and mean (delta) peak glucose levels were found (p<0.05). No clinically relevant differences in gastrointestinal tolerance were observed. CONCLUSIONS Using DSF resulted in significantly better 24h and postprandial glucose profiles than fibre-containing SF after bolus administration and may therefore help to improve glycaemic control in diabetic patients.