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1. Type 1 diabetes control and pregnancy outcomes in women treated with continuous subcutaneous insulin infusion (CSII) or with insulin glargine and multiple daily injections of rapid-acting insulin analogues (glargine-MDI).

Author

Bruttomesso D, Bonomo M, Costa S, Dal Pos M, Di Cianni G, Pellicano F, Vitacolonna E, Dodesini AR, Tonutti L, Lapolla A, Di Benedetto A, and Torlone E

Subjects
Adult, Diabetes Complications mortality, Diabetes Complications prevention & control, Diabetes Mellitus, Type 1 mortality, Female, Fetal Diseases mortality, Fetal Diseases prevention & control, Humans, Infant, Newborn, Infusions, Subcutaneous, Insulin Glargine, Insulin Infusion Systems, Morbidity, Pregnancy, Pregnancy in Diabetics mortality, Retrospective Studies, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemic Agents administration & dosage, Insulin, Long-Acting administration & dosage, Pregnancy Outcome, Pregnancy in Diabetics drug therapy
Abstract

Aim: The best way to treat pregnant patients who have type 1 diabetes is still unclear. For this reason, the present study compared metabolic control and maternal-fetal outcomes in patients treated with continuous subcutaneous infusions of rapid-acting insulin analogues (CSII) or with insulin glargine and multiple daily injections of rapid-acting insulin analogues (glargine-MDI)., Methods: This retrospective multicentre study involved 144 women with type 1 diabetes, 100 of whom were using CSII and 44 glargine-MDI. Outcomes analyzed were metabolic control, diabetes complications, pregnancy outcome, perinatal morbidity and mortality, and fetal malformations., Results: The two groups were comparable for age, prepregnancy BMI, primiparous rate and diabetes complications, although patients using CSII had longer duration of diabetes (P=0.03) and higher White classifications (P=0.04). In both groups, metabolic control improved during pregnancy, but good control was reached earlier among patients using CSII. At parturition, patients using CSII had lower HbA(1c) (6.2±0.7% vs 6.5±0.8%; P=0.02) and required less insulin (P<0.01). Weight gain was similar in both groups, and maternal-fetal outcomes did not differ., Conclusion: In pregnant patients with type 1 diabetes, MDI and CSII are equivalent in terms of metabolic control and fetal-maternal outcomes, although patients using CSII achieved good control earlier and with less insulin., (Copyright © 2011 Elsevier Masson SAS. All rights reserved.)

Published
2011
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2. Use of insulin detemir in pregnancy: a report on 10 Type 1 diabetic women.

Author

Lapolla A, Di Cianni G, Bruttomesso D, Dalfrà MG, Fresa R, Mello G, Napoli A, Romanelli T, Sciacca L, Stefanelli G, Torlone E, and Mannino D

Subjects
Adult, Female, Humans, Insulin therapeutic use, Insulin Detemir, Insulin, Long-Acting, Pregnancy, Diabetes Mellitus, Type 1 drug therapy, Fetal Development drug effects, Hypoglycemic Agents therapeutic use, Insulin analogs & derivatives, Pregnancy in Diabetics
Published
2009
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3. Insulin analogs and pregnancy: an update.

Author

Torlone E, Di Cianni G, Mannino D, and Lapolla A

Subjects
Female, Humans, Hypoglycemic Agents pharmacology, Insulin pharmacology, Insulin therapeutic use, Insulin Aspart, Insulin Detemir, Insulin Glargine, Insulin Lispro, Insulin, Long-Acting, Pregnancy, Diabetes, Gestational drug therapy, Hypoglycemic Agents therapeutic use, Insulin analogs & derivatives
Abstract

It is well known that good metabolic control maintained throughout pregnancy reduces maternal and fetal complications in diabetes. Before conception and throughout pregnancy, insulin therapy needs to be optimized and, in this context, the insulin analogs currently available in the market may help to achieve good metabolic control. We therefore review here what is known about the potential benefits and risks related to the use of these new insulins in pregnancy. Clinical and experimental data on insulin aspart and lispro strongly suggest that they have no adverse maternal or fetal effects during pregnancy in women with pregestational and gestational diabetes, and that their use results in improved glycemic control, fewer hypoglycemic episodes, and improved patient satisfaction. At present there are no published data on the use of glulisine in pregnancy. Insulin glargine during pregnancy is not recommended but, in the last years, larger surveys (retrospective and case-control studies) have been published on this field and, to date, results of about 335 pregnancies with type 1 diabetes are available showing an incidence of congenital malformation similar to that obtained with human insulin. There are no published data concerning the use of detemir in pregnancy but the results of a prospective study are expected in 2010.

Published
2009
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4. Perinatal outcomes associated with the use of glargine during pregnancy.

Author

Di Cianni G, Torlone E, Lencioni C, Bonomo M, Di Benedetto A, Napoli A, Vitacolonna E, Mannino D, and Lapolla A

Subjects
Adult, Birth Weight drug effects, Blood Glucose drug effects, Case-Control Studies, Female, Fetal Macrosomia chemically induced, Humans, Infant Mortality, Infant, Newborn, Insulin adverse effects, Insulin Glargine, Insulin, Long-Acting, Italy, Pregnancy, Pregnancy Outcome, Retrospective Studies, Abnormalities, Drug-Induced etiology, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemic Agents adverse effects, Insulin analogs & derivatives, Pregnancy in Diabetics drug therapy
Abstract

Aims: Insulin glargine (IG), with its non-peaking action profile, might be useful in diabetic pregnancy. However, data on its safety are limited and its use during pregnancy is not recommended. This study focused on the effects of IG on perinatal outcome, particularly to estimate the rate of congenital anomalies and birthweight., Methods: This retrospective study included women with pre-gestational diabetes who used IG before (at least 1 month) and during pregnancy. For all women we recorded data regarding maternal glycaemic control and pregnancy outcome. We also compared women treated with IG throughout pregnancy and women who stopped taking IG at an earlier stage., Results: From 27 centres, 107 Type 1 diabetic pregnancies were identified. IG was started 10.3 +/- 6.9 months before conception and in 57.4% of cases was stopped during the first trimester; 42.6% of women continued using it until the end of pregnancy. There were six abortions (four spontaneous and two induced) and five newborns (4.9%) with congenital anomalies. Glycaemic control, birthweight and the prevalence of macrosomia and neonatal morbidity were similar in women who used IG for the full term compared with those who stopped IG earlier during pregnancy., Conclusions: This study, although limited, suggests that IG is safe and effective; the rate of congenital malformations was within the range expected for diabetic pregnancies treated with more traditional forms of insulin. IG used throughout pregnancy did not seem to influence birthweight or increase adverse outcomes.

Published
2008
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5. Outcome of pregnancy in type 1 diabetic patients treated with insulin lispro or regular insulin: an Italian experience.

Author

Lapolla A, Dalfrà MG, Spezia R, Anichini R, Bonomo M, Bruttomesso D, Di Cianni G, Franzetti I, Galluzzo A, Mello G, Menato G, Napoli A, Noacco G, Parretti E, Santini C, Scaldaferri E, Scaldaferri L, Songini M, Tonutti L, Torlone E, Gentilella R, Rossi A, and Valle D

Subjects
Birth Weight, Chromatography, High Pressure Liquid, Diabetes Mellitus, Type 1 complications, Female, Glycated Hemoglobin metabolism, Humans, Infant, Newborn, Infant, Small for Gestational Age, Insulin Lispro, Italy, Pregnancy, Retrospective Studies, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemic Agents therapeutic use, Insulin analogs & derivatives, Insulin therapeutic use, Pregnancy Complications drug therapy
Abstract

Some studies have shown that fetal outcome observed in patients using insulin lispro is much the same as in pregnant women using regular insulin. This study aims to analyze the Italian data emerging from a multinational, multicenter, retrospective study on mothers with type 1 diabetes mellitus before pregnancy, comparing those treated with insulin lispro for at least 3 months before and 3 months after conception with those treated with regular insulin. The data collected on pregnant women with diabetes attending 15 Italian centers from 1998 to 2001 included: HbA1c at conception and during the first and third trimesters, frequency of severe hypoglycemic episodes, spontaneous abortions, mode and time of delivery, fetal malformations and mortality. Seventy-two diabetic pregnancies treated with lispro and 298 treated with regular insulin were analyzed, revealing a trend towards fewer hypoglycemic episodes in the former, who also had a significantly greater reduction in HbA1c during the first trimester. The rate of congenital malformations was similar in the offspring of the two groups of women treated with insulin lispro or regular insulin. These findings suggest that insulin lispro could be useful for the treatment of hyperglycemia in type 1 diabetic pregnant women.

Published
2008
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6. Successful use of insulin glargine during entire pregnancy until delivery in six Type 1 diabetic women.

Author

Torlone E, Gennarini A, Ricci NB, and Bolli GB

Subjects
Adult, Female, Fertilization drug effects, Humans, Infant, Newborn, Insulin therapeutic use, Insulin Glargine, Insulin, Long-Acting, Male, Pregnancy, Blood Glucose drug effects, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemic Agents therapeutic use, Insulin analogs & derivatives, Pregnancy Outcome, Pregnancy in Diabetics drug therapy
Published
2007
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7. Better long-term glycaemic control with the basal insulin glargine as compared with NPH in patients with Type 1 diabetes mellitus given meal-time lispro insulin.

Author

Porcellati F, Rossetti P, Pampanelli S, Fanelli CG, Torlone E, Scionti L, Perriello G, and Bolli GB

Subjects
Adult, Blood Glucose drug effects, Blood Glucose metabolism, Blood Glucose Self-Monitoring, Cognition drug effects, Diabetes Mellitus, Type 1 blood, Drug Administration Schedule, Drug Therapy, Combination, Female, Glycated Hemoglobin metabolism, Humans, Hypoglycemia chemically induced, Hypoglycemic Agents adverse effects, Insulin adverse effects, Insulin Glargine, Insulin Lispro, Insulin, Isophane adverse effects, Insulin, Isophane therapeutic use, Insulin, Long-Acting, Male, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemic Agents therapeutic use, Insulin analogs & derivatives, Insulin therapeutic use
Abstract

Background: Glargine is a long-acting insulin analogue potentially more suitable than NPH insulin in intensive treatment of Type 1 diabetes mellitus (T1 DM), but no study has proven superiority. The aim of this study was to test superiority of glargine on long-term blood glucose (BG) as well as on responses to hypoglycaemia vs. NPH., Methods: One hundred and twenty-one patients with T1 DM on intensive therapy on four times/day NPH and lispro insulin at each meal, were randomized to either continuation of NPH four times/day (n = 60), or once daily glargine at dinner-time (n = 61) for 1 year. Lispro insulin at meal-time was continued in both groups. In 11 patients from each group, responses to stepped hyperinsulinaemic-hypoglycaemia were measured before and after 1 year's treatment., Results: Mean daily BG was lower with glargine [7.6 +/- 0.11 mmol/l (137 +/- 2 mg/dl)] vs. NPH [8.1 +/- 0.22 mmol/l (146 +/- 4 mg/dl)] (P < 0.05). HbA(1c) at 4 months did not change with NPH, but decreased with glargine (from 7.1 +/- 0.1 to 6.7 +/- 0.1%), and remained lower than NPH at 12 months (6.6 +/- 0.1%, P < 0.05 vs. NPH). Frequency of mild hypoglycaemia [self-assisted episodes, blood glucose < or = 4.0 mmol/l (72 mg/dl)] was lower with glargine vs. NPH (7.2 +/- 0.5 and 13.2 +/- 0.6 episodes/patient-month, P < 0.05). After 1 year, NPH treatment resulted in no change of responses to hypoglycaemia, whereas with glargine plasma glucose, thresholds and maximal responses of plasma adrenaline and symptoms to hypoglycaemia improved (P < 0.05)., Conclusions: The simpler glargine regimen decreases the percentage of HbA(1c) and frequency of hypoglycaemia and improves responses to hypoglycaemia more than NPH. Thus, glargine appears more suitable than NPH as basal insulin for intensive treatment of T1 DM.

Published
2004
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8. Intensive replacement of basal insulin in patients with type 1 diabetes given rapid-acting insulin analog at mealtime: a 3-month comparison between administration of NPH insulin four times daily and glargine insulin at dinner or bedtime.

Author

Rossetti P, Pampanelli S, Fanelli C, Porcellati F, Costa E, Torlone E, Scionti L, and Bolli GB

Subjects
Adult, Drug Administration Schedule, Eating, Fasting, Female, Humans, Insulin administration & dosage, Insulin blood, Insulin Glargine, Insulin Lispro, Insulin, Long-Acting, Male, Postprandial Period, Blood Glucose metabolism, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemic Agents therapeutic use, Insulin analogs & derivatives, Insulin therapeutic use, Insulin, Isophane therapeutic use
Abstract

Objective: To establish differences in blood glucose between different regimens of optimized basal insulin substitution in type 1 diabetic patients given lispro insulin at meals, i.e., NPH injected four times a day versus glargine insulin once daily at dinner or at bedtime., Research Design and Methods: A total of 51 patients with type 1 diabetes on intensive therapy (NPH four times/day and lispro insulin at each meal) were randomized to three different regimens of basal insulin substitution while continuing lispro insulin at meals: continuation of NPH four times/day (n = 17), once daily glargine at dinnertime (n = 17), and once daily glargine at bedtime (n = 17) for 3 months. Blood glucose targets were fasting, preprandial, and bedtime concentrations at 6.4-7.2 mmol/l and 2 h after meals at 8.0-9.2 mmol/l. The primary end point was HbA(1c)., Results: Mean daily blood glucose was lower with dinnertime glargine (7.5 +/- 0.2 mmol/l) or bedtime glargine (7.4 +/- 0.2 mmol/l) versus NPH (8.3 +/- 0.2 mmol/l) (P < 0.05). A greater percentage of blood glucose values were at the target value with glargine at dinner and bedtime versus those with NPH (P < 0.05). HbA(1c) at 3 months did not change with NPH but decreased with glargine at dinnertime (from 6.8 +/- 0.2 to 6.4 +/- 0.1%) and glargine at bedtime (from 7.0 +/- 0.2 to 6.6 +/- 0.1%) (P < 0.04 vs. NPH). Total daily insulin doses were similar with the three treatments, but with glargine there was an increase in basal and a decrease in mealtime insulin requirements (P < 0.05). Frequency of mild hypoglycemia (self-assisted episodes, blood glucose < or =4.0 mmol/l) was lower with glargine (dinnertime 8.1 +/- 0.8 mmol/l, bedtime 7.7 +/- 0.9 mmol/l) than with NPH (12.2 +/- 1.3 mmol/l) (episodes/patient-month, P < 0.04). In-hospital profiles confirmed outpatient blood glucose data and indicated more steady plasma insulin concentrations at night and before meals with glargine versus NPH (P < 0.05). There were no differences between glargine given at dinnertime and at bedtime., Conclusions: Regimens of basal insulin with either NPH four times/day or glargine once/day in type 1 diabetic patients both result in good glycemic control. However, the simpler glargine regimen decreases the HbA(1c) level and frequency of hypoglycemia versus NPH. In contrast to NPH, which should be given at bedtime, insulin glargine can be administered at dinnertime without deteriorating blood glucose control.

Published
2003
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9. Contribution of postprandial versus interprandial blood glucose to HbA1c in type 1 diabetes on physiologic intensive therapy with lispro insulin at mealtime.

Author

Ciofetta M, Lalli C, Del Sindaco P, Torlone E, Pampanelli S, Mauro L, Chiara DL, Brunetti P, and Bolli GB

Subjects
Adult, Circadian Rhythm, Drug Administration Schedule, Eating, Female, Humans, Hypoglycemic Agents administration & dosage, Insulin administration & dosage, Insulin therapeutic use, Insulin Lispro, Male, Postprandial Period, Blood Glucose metabolism, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 drug therapy, Glycated Hemoglobin metabolism, Hypoglycemic Agents therapeutic use, Insulin analogs & derivatives
Abstract

Objective: To quantitate the contribution of postprandial blood glucose, which improves with the short-acting insulin analog lispro [Lys(B28),Pro(B29)] in type 1 diabetes, to the overall 24-h blood glucose concentration and the long-term HbA1c concentration under conditions of different postabsorptive blood glucose., Research Design and Methods: A total of 24 type 1 diabetic patients on long-term intensive therapy with premeal human regular insulin (Hum-R) and bedtime NPH were randomly assigned to a continuation of Hum-R (group 1, n = 8), lispro (group 2, n = 8), or lispro + NPH (in variable proportions) administered at mealtime (group 3, n = 8) for 3 months, NPH administered at bedtime was continued in all three groups. Data from home blood glucose monitoring were collected, and a 24-h plasma glucose and insulin profile was obtained during a 2-day hospital visit to calculate areas under the postprandial glucose curve (3.5 h after breakfast, 3.5 h after lunch, and 3.0 h after dinner for a total of 10.0 h) and the postabsorptive blood glucose curve (the remaining 14.0 h out of 24.0 h) (AUC). Eight nondiabetic subjects were also studied., Results: The substitution of Hum-R with lispro (group 2) resulted in lower postprandial blood glucose, but greater postabsorptive blood glucose (P < 0.05 vs. group 1). The postprandial blood glucose AUC was lower (161 +/- 19 vs. 167 +/- 20 mg.100 ml-1.h-1), but the postabsorptive blood glucose AUC was greater (155 +/- 22 vs. 142 +/- 19 mg.100 ml-1.h-1) (P < 0.05). Therefore, the 24-h blood glucose AUC was no different (NS). Consequently, HbA1c was no different (NS). This occurred because in group 2, mealtime lispro resulted in normal prandial plasma insulin, but also resulted in lower interprandial concentration (P < 0.05 vs. group 1). When NPH was added to lispro (30% at breakfast, 40% at lunch, 10% at dinner) in group 3, postabsorptive plasma insulin was similar to group 1 (NS), in group 3, the postprandial blood glucose AUC (153 +/- 17 mg.100 ml-1.h-1) was lower and the postabsorptive blood glucose AUC was no different, as compared with group 1 (NS). Therefore, the 24-h blood glucose AUC was lower (147 +/- 17 vs. 155 +/- 21 and 158 +/- 20 mg.100 ml-1.h-1), and HbA1c was lower (6.41 +/- 0.12 vs. 6.84 +/- 0.2 and 6.96 +/- 0.2% (groups 3, 1, and 2 respectively, P < 0.05). Frequency of hypoglycemia was greater in group 2 (P < 0.05), but not in group 3 (NS) vs. group 1.

Published
1999
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10. Long-term intensive treatment of type 1 diabetes with the short-acting insulin analog lispro in variable combination with NPH insulin at mealtime.

Author

Lalli C, Ciofetta M, Del Sindaco P, Torlone E, Pampanelli S, Compagnucci P, Cartechini MG, Bartocci L, Brunetti P, and Bolli GB

Subjects
Adult, Diabetes Mellitus, Type 1 blood, Drug Administration Schedule, Drug Combinations, Female, Glycated Hemoglobin analysis, Humans, Hypoglycemic Agents administration & dosage, Insulin administration & dosage, Insulin therapeutic use, Insulin Lispro, Insulin, Isophane administration & dosage, Male, Time Factors, Diabetes Mellitus, Type 1 drug therapy, Eating physiology, Hypoglycemic Agents therapeutic use, Insulin analogs & derivatives, Insulin, Isophane therapeutic use
Abstract

Objective: To establish whether the short-acting insulin analog lispro can be successfully implemented in long-term intensive insulin therapy in type 1 diabetes, and if so, what its effects are on glycemic control and frequency and awareness of hypoglycemia., Research Design and Methods: We randomized 56 type 1 diabetic patients to treatment with either lispro (n = 28) or human regular insulin (Hum-R; n = 28) as mealtime insulin for 1 year (open design, parallel groups). Lispro was injected at mealtime and Hum-R was given 10-40 min before meals (bedtime NPH was continued on both occasions). With lispro, NPH was added at breakfast (approximately 70/30), lunch (approximately 60/40), and supper (approximately 80/20) (mixing percentage of lispro/NPH) to optimize premeal and bedtime blood glucose., Results: Total daily insulin units were no different in the two treatment groups, but with lispro approximately 30% less short-acting insulin at meals and approximately 30% more NPH was needed versus Hum-R (P < 0.05). The bedtime NPH dosage was no different. With lispro + NPH, the mean daily blood glucose was lower than with Hum-R (8.0 +/- 0.1 vs. 8.8 +/- 0.1 mmol/l; P < 0.05), HbA1c was lower (6.34 +/- 0.10 vs. 6.71 +/- 0.11%, mean value over 1 year; P < 0.002), and hypoglycemia (blood glucose < or = 3.8 mmol/l) was less frequent (7.4 +/- 0.5 vs. 11.5 +/- 0.7 episodes/patient-month) and tended to occur more within 90 min after meals than in the postabsorptive state (P < 0.05 vs. Hum-R). After 1 year, plasma adrenaline and symptom responses to experimental, stepped hypoglycemia improved with lispro and were closer to the responses of 12 nondiabetic control subjects versus Hum-R both in terms of thresholds and magnitude (P < 0.05)., Conclusions: We concluded that mealtime injection of lispro + NPH improves the 24-h blood glucose and the percentage HbA1c as compared with Hum-R. The improvement can be maintained long term. Intensive therapy with lispro + NPH results in less frequent hypoglycemia and better awareness and counterregulation of hypoglycemia.

Published
1999
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11. Use of the short-acting insulin analogue lispro in intensive treatment of type 1 diabetes mellitus: importance of appropriate replacement of basal insulin and time-interval injection-meal.

Author

Del Sindaco P, Ciofetta M, Lalli C, Perriello G, Pampanelli S, Torlone E, Brunetti P, and Bolli GB

Subjects
Adult, Blood Glucose metabolism, Body Weight, Cross-Over Studies, Diabetes Mellitus, Type 1 blood, Female, Glycated Hemoglobin metabolism, Humans, Hypoglycemia chemically induced, Insulin adverse effects, Insulin therapeutic use, Insulin Lispro, Male, Solubility, Time Factors, Diabetes Mellitus, Type 1 drug therapy, Food, Hypoglycemic Agents, Insulin administration & dosage, Insulin analogs & derivatives
Abstract

To establish whether lispro may be a suitable short-acting insulin preparation for meals in intensive treatment of Type 1 diabetes mellitus (DM) in patients already in chronic good glycaemic control with conventional insulins, 69 patients on intensive therapy (4 daily s.c. insulin injections, soluble at each meal, NPH at bedtime, HbA1c <7.5%) were studied with an open, cross-over design for two periods of 3 months each (lispro or soluble). The % HbA1c and frequency of hypoglycaemia were assessed under four different conditions (Groups I-IV). Lispro was always injected at mealtime, soluble 10-40 min prior to meals (with the exception of Group IV). Bedtime NPH was continued with both treatments. When lispro replaced soluble with no increase in number of daily NPH injections (Group I, n = 15), HbA1c was no different (p = NS), but frequency of hypoglycaemia was greater (p < 0.05). When NPH was given 3-4 times daily, lispro (Group II, n = 18), but not soluble (Group III, n = 12) decreased HbA1c by 0.35 +/- 0.25% with no increase in hypoglycaemia. When soluble was injected at mealtimes, HbA1c increased by 0.18 +/- 0.15% and hypoglycaemia was more frequent than when soluble was injected 10-40 min prior to meals (Group IV, n = 24) (p < 0.05). It is concluded that in intensive management of Type 1 DM, lispro is superior to soluble in terms of reduction of % HbA1c and frequency of hypoglycaemia, especially for those patients who do not use a time interval between insulin injection and meal. However, these goals cannot be achieved without optimization of basal insulin.

Published
1998
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12. Pharmacokinetics, pharmacodynamics and glucose counterregulation following subcutaneous injection of the monomeric insulin analogue [Lys(B28),Pro(B29)] in IDDM.

Author

Torlone E, Fanelli C, Rambotti AM, Kassi G, Modarelli F, Di Vincenzo A, Epifano L, Ciofetta M, Pampanelli S, and Brunetti P

Subjects
Adult, Blood Glucose analysis, Cognition physiology, Diabetes Mellitus, Type 1 complications, Female, Humans, Hypoglycemia chemically induced, Hypoglycemia metabolism, Hypoglycemic Agents pharmacokinetics, Infusions, Intravenous, Injections, Subcutaneous, Insulin blood, Insulin pharmacokinetics, Insulin pharmacology, Insulin Lispro, Liver metabolism, Male, Diabetes Mellitus, Type 1 metabolism, Glucose metabolism, Hypoglycemic Agents pharmacology, Insulin analogs & derivatives
Abstract

The aim of these studies was to compare the pharmacokinetics, pharmacodynamics, counterregulatory hormone and symptom responses, as well as cognitive function during hypoglycaemia induced by s.c. injection of 0.15 IU/kg of regular human insulin (HI) and the monomeric insulin analogue [Lys(B28),Pro (B29)] (MI) in insulin-dependent-diabetic (IDDM) subjects. In these studies glucose was infused whenever needed to prevent decreases in plasma glucose below 3 mmol/l. After MI, plasma insulin increased earlier to a peak (60 vs 90 min) which was greater than after HI (294 +/- 24 vs 255 +/- 24 pmol/l), and plasma glucose decreased earlier to a 3 mmol/l plateau (60 vs 120 min) (p < 0.05). The amount of glucose infused to prevent plasma glucose falling below 3 mmol/l was approximately three times greater after MI than HI (293 +/- 26 vs 90 +/- 25 mumol.kg-1 x 60-375 min-1, p < 0.05). After MI, hepatic glucose production was more suppressed (0.7 +/- 1 vs 5.9 +/- 0.54 mumol.kg-1.min-1) and glucose utilization was less suppressed than after HI (11.6 +/- 0.65 vs 9.1 +/- 0.11 mumol.kg-1.min-1) (p < 0.05). Similarly, plasma NEFA, glycerol, and beta-OH-butyrate were more suppressed after MI than HI (p < 0.05), whereas plasma lactate increased only after MI, but not after HI. Responses of counterregulatory hormones, symptoms and deterioration in cognitive function during plasma glucose plateau of 3 mmol/l were superimposable after MI and HI (p = NS).(ABSTRACT TRUNCATED AT 250 WORDS)

Published
1994
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13. Continuous Subcutaneous Insulin Infusion in Italy: Third National Survey

Author

Bruttomesso D., Laviola L., Lepore G., Bonfanti R., Bozzetto L., Corsi A., Di Blasi V., Girelli A., Grassi G., Iafusco D., Rabbone I., Schiaffini R., Montani V., Colleluori P., Paciotti V., Alfidi P., Grosso J., Tumini S., Cipriano P., Vitacolonna E., Di Vieste G., Minnucci A., Antenucci D., La Penna G., Taraborrelli M., Macerala B., Citro G., De Morelli G., Gnasso A., Irace C., Citriniti F., Lazzaro N., Bruzzese M., Mammi F., De Berardinis F., Santoro E., Corigliano G., Corigliano M., Parillo M., Schettino M., Fresa R., Annuzzi G., Bassi V., Santinelli C., Buono P., Mozzillo E., De Feo E., Esposito K., Petrizzo M., Foglia A., Gatti A., Gentile S., Guarino G., Zanfardino A., Lambiase C., Vitale A., Zucchini S., Maltoni G., Forlani G., Moscatiello S., Suprani T., Bensa M., Tomasi F., Monesi M., Nizzoli M., Acquati S., Chierici G., Milli B., Iughetti L., Predieri B., Cavani R., Romano S., Manicardi V., Michelini M., Cimicchi M. C., Ugolotti D., Zavaroni I., Dei Cas A., Dall'Aglio E., Papi M., Tardio S. M., Calderini M. C., Riboni S., D'Amato L., Zavaroni D., Gastaldi L., Di Bartolo P., Pellicano F., Cirillo A., Graziani V., Di Secli C., Amarri S., Lasagni A., Marsciani A., Pedini A., Pagliani U., Rossi C., Tortul C., Brunato B., Assaloni R., Zanette G., Livolsi P., Petrucco A., Tercelj K., Manca E., Candido R., Tommasi E., Tornese G., Faleschini E., Tonutti L., Agus S., Zanatta M., Rosolen A., Comici A., Graziano F. M., Misischi I., Pozzilli P., Maurizi A. R., Falasca P., Tuccinardi F., Ricciardi G. P., Di Masa P., Ragonese M., Cipolloni L., Buzzetti R., Moretti C., Leto G., Crino A., Bocchini S., Di Perna P., Giuliano M., Frontoni S., Malandrucco I., Pitocco D., Scalpone R., Toscanella F., Cappa M., Ventura C., Bonato V., De Bernardinis M., Cavallo M. G., Leonetti F., Morano S., Mandosi E., Cicconetti E., Ciampittiello G., Marini M. A., Sabato D., Napoli A., Giraudo F., Toscano V., Massimiani F., Fava D., Gargiulo P., Mecca N., Tubili C., Nardone M. R., Morviducci L., Manca-Bitti M. L., Arcano S., Leotta S., Suraci C., Chiaramonte F., Visalli N., Forte E., Palmacci C., Arnaldi C., Tosini D., Querci F., Trevisan R., Bonfadini S., Prandi E., Felappi B., Locatelli F., Fuso V., Rocca A., Meneghini E., Massafra C., Terni T., Elli P., Ruggeri P., Carrai E., Musacchio N., Lovagnini Scher C. A., Marelli G., Vilei V., Richini D., Inversini C., Franzetti I., Bonacina M., Ciucci A., Sciangula L., Duratorre E., Bonomo M., Bertuzzi F., Chebat E., Muratori M., Scaramuzza A., Zuccotti G. V., Bollati P. M., Colapinto P., Orsi E., Palmieri E., Laurenzi A., Molinari C., Frontino G., Veronelli A., Zecchini B., Bianchi A., Torchio G., Lovati E., Ghilardi G., Dagani R., Carugo D., Berra C., Favacchio G., Fochesato E., Pissarelli A., Bucciarelli L., Bulgheroni M., Guerraggio L., Zonca S., Bossi A. C., Berzi D., Mangone I., Cazzaniga E., Rabini R. A., Boemi M., Faloia E., Boscaro M., Sternari G., Iannilli A., Cherubini V., Busciantella Ricci N., Cartechini M. G., Tesei A. M., Maolo G., Galetta M., Vespasiani G., Tinti G., Manfrini S., Aiello A., Di Vincenzo S., Vitale C., Di Caro P., Lera R., Secco A., Lesina A., Romeo F., Origlia C., Giorda C., Chiambretti A. M., Fornengo R., De Donno V., Gallarotti F., Manti R., Marafetti L., Cadario F., Savastio S., Barbieri P., Massucco P., Ali A., Gottero C., Degiovanni M., Bertaina S., Maghenzani G., Tinti D., Fontana F., Giorgino F., Stefanelli G., Cavallo L., Zecchino C., Piccinno E., Ortolani F., Gallo F., Moramarco F., Marino A., Sparasci G., Mileti G., Lamacchia O., Picca G., Coccioli M. S., Micale F., Serra R., Romano I., Savino T., De Cosmo S., Rauseo A., Delvecchio M., Lapolla R., Braione A. F., Papagno G., Baroni M., Melis M., Cossu E., Songini M., Cambuli V. M., Lo Presti D., Timpanaro T. A., Chiavetta A., Garofalo M. R., Tommaselli L., Tumminia A., Scarpitta A. M., Di Benedetto A., Giunta L., Lombardo F., Salzano G., Cardella F., Roppolo R., Provenzano V., Fleres M., Migliorini S., De Luca A., Leopardi A., Beltrami C., Toni S., Guasti G., Lenzi L., Lamanna C., Mannucci E., Lucchesi S., Dicianni G., Aragona M., Del Prato S., Fattor B., Eisath J., Pasquino B., Reinstadler P., Kaufmann P., Incelli G., Rauch S., Romanelli T., Cauvin V., Franceschi R., Soldani C., Scattoni R., Norgiolini R., Celleno R., Torlone E., Bolli G. B., Lalli C., Scarponi M., Bobbio A., Bechaz M., Pianta A., Marangoni A., Arico C. N., Alagona C., Confortin L., Rossi E., Boscolo Bariga A., Nogara A., Bettio M., Frison V., Guidoni G. L., Fongher C., Contin M. L., Cosma A., Vianello S., Bondesan L., Morea A., Volpi A., Coracina A., Panebianco G., Lombardi S., Costa S., Cipponeri E., Vedovato M., Scotton R., Monciotti C. M., Galderisi A., Dalfra M. G., Lapolla A., Zanon M., Lisato G., Mollo F., Calcaterra F., Miola M., Paccagnella A., Sambataro M., Moro E., Trombetta M., Negri C., Sabbion A., Maffeis C., Strazzabosco M., Mesturino C. A., Mingardi R., Bruttomesso, D., Laviola, L., Lepore, G., Bonfanti, R., Bozzetto, L., Corsi, A., Di Blasi, V., Girelli, A., Grassi, G., Iafusco, D., Rabbone, I., Schiaffini, R., Montani, V., Colleluori, P., Paciotti, V., Alfidi, P., Grosso, J., Tumini, S., Cipriano, P., Vitacolonna, E., Di Vieste, G., Minnucci, A., Antenucci, D., La Penna, G., Taraborrelli, M., Macerala, B., Citro, G., De Morelli, G., Gnasso, A., Irace, C., Citriniti, F., Lazzaro, N., Bruzzese, M., Mammi, F., De Berardinis, F., Santoro, E., Corigliano, G., Corigliano, M., Parillo, M., Schettino, M., Fresa, R., Annuzzi, G., Bassi, V., Santinelli, C., Buono, P., Mozzillo, E., De Feo, E., Esposito, K., Petrizzo, M., Foglia, A., Gatti, A., Gentile, S., Guarino, G., Zanfardino, A., Lambiase, C., Vitale, A., Zucchini, S., Maltoni, G., Forlani, G., Moscatiello, S., Suprani, T., Bensa, M., Tomasi, F., Monesi, M., Nizzoli, M., Acquati, S., Chierici, G., Milli, B., Iughetti, L., Predieri, B., Cavani, R., Romano, S., Manicardi, V., Michelini, M., Cimicchi, M. C., Ugolotti, D., Zavaroni, I., Dei Cas, A., Dall'Aglio, E., Papi, M., Tardio, S. M., Calderini, M. C., Riboni, S., D'Amato, L., Zavaroni, D., Gastaldi, L., Di Bartolo, P., Pellicano, F., Cirillo, A., Graziani, V., Di Secli, C., Amarri, S., Lasagni, A., Marsciani, A., Pedini, A., Pagliani, U., Rossi, C., Tortul, C., Brunato, B., Assaloni, R., Zanette, G., Livolsi, P., Petrucco, A., Tercelj, K., Manca, E., Candido, R., Tommasi, E., Tornese, G., Faleschini, E., Tonutti, L., Agus, S., Zanatta, M., Rosolen, A., Comici, A., Graziano, F. M., Misischi, I., Pozzilli, P., Maurizi, A. R., Falasca, P., Tuccinardi, F., Ricciardi, G. P., Di Masa, P., Ragonese, M., Cipolloni, L., Buzzetti, R., Moretti, C., Leto, G., Crino, A., Bocchini, S., Di Perna, P., Giuliano, M., Frontoni, S., Malandrucco, I., Pitocco, D., Scalpone, R., Toscanella, F., Cappa, M., Ventura, C., Bonato, V., De Bernardinis, M., Cavallo, M. G., Leonetti, F., Morano, S., Mandosi, E., Cicconetti, E., Ciampittiello, G., Marini, M. A., Sabato, D., Napoli, A., Giraudo, F., Toscano, V., Massimiani, F., Fava, D., Gargiulo, P., Mecca, N., Tubili, C., Nardone, M. R., Morviducci, L., Manca-Bitti, M. L., Arcano, S., Leotta, S., Suraci, C., Chiaramonte, F., Visalli, N., Forte, E., Palmacci, C., Arnaldi, C., Tosini, D., Querci, F., Trevisan, R., Bonfadini, S., Prandi, E., Felappi, B., Locatelli, F., Fuso, V., Rocca, A., Meneghini, E., Massafra, C., Terni, T., Elli, P., Ruggeri, P., Carrai, E., Musacchio, N., Lovagnini Scher, C. A., Marelli, G., Vilei, V., Richini, D., Inversini, C., Franzetti, I., Bonacina, M., Ciucci, A., Sciangula, L., Duratorre, E., Bonomo, M., Bertuzzi, F., Chebat, E., Muratori, M., Scaramuzza, A., Zuccotti, G. V., Bollati, P. M., Colapinto, P., Orsi, E., Palmieri, E., Laurenzi, A., Molinari, C., Frontino, G., Veronelli, A., Zecchini, B., Bianchi, A., Torchio, G., Lovati, E., Ghilardi, G., Dagani, R., Carugo, D., Berra, C., Favacchio, G., Fochesato, E., Pissarelli, A., Bucciarelli, L., Bulgheroni, M., Guerraggio, L., Zonca, S., Bossi, A. C., Berzi, D., Mangone, I., Cazzaniga, E., Rabini, R. A., Boemi, M., Faloia, E., Boscaro, M., Sternari, G., Iannilli, A., Cherubini, V., Busciantella Ricci, N., Cartechini, M. G., Tesei, A. M., Maolo, G., Galetta, M., Vespasiani, G., Tinti, G., Manfrini, S., Aiello, A., Di Vincenzo, S., Vitale, C., Di Caro, P., Lera, R., Secco, A., Lesina, A., Romeo, F., Origlia, C., Giorda, C., Chiambretti, A. M., Fornengo, R., De Donno, V., Gallarotti, F., Manti, R., Marafetti, L., Cadario, F., Savastio, S., Barbieri, P., Massucco, P., Ali, A., Gottero, C., Degiovanni, M., Bertaina, S., Maghenzani, G., Tinti, D., Fontana, F., Giorgino, F., Stefanelli, G., Cavallo, L., Zecchino, C., Piccinno, E., Ortolani, F., Gallo, F., Moramarco, F., Marino, A., Sparasci, G., Mileti, G., Lamacchia, O., Picca, G., Coccioli, M. S., Micale, F., Serra, R., Romano, I., Savino, T., De Cosmo, S., Rauseo, A., Delvecchio, M., Lapolla, R., Braione, A. F., Papagno, G., Baroni, M., Melis, M., Cossu, E., Songini, M., Cambuli, V. M., Lo Presti, D., Timpanaro, T. A., Chiavetta, A., Garofalo, M. R., Tommaselli, L., Tumminia, A., Scarpitta, A. M., Di Benedetto, A., Giunta, L., Lombardo, F., Salzano, G., Cardella, F., Roppolo, R., Provenzano, V., Fleres, M., Migliorini, S., De Luca, A., Leopardi, A., Beltrami, C., Toni, S., Guasti, G., Lenzi, L., Lamanna, C., Mannucci, E., Lucchesi, S., Dicianni, G., Aragona, M., Del Prato, S., Fattor, B., Eisath, J., Pasquino, B., Reinstadler, P., Kaufmann, P., Incelli, G., Rauch, S., Romanelli, T., Cauvin, V., Franceschi, R., Soldani, C., Scattoni, R., Norgiolini, R., Celleno, R., Torlone, E., Bolli, G. B., Lalli, C., Scarponi, M., Bobbio, A., Bechaz, M., Pianta, A., Marangoni, A., Arico, C. N., Alagona, C., Confortin, L., Rossi, E., Boscolo Bariga, A., Nogara, A., Bettio, M., Frison, V., Guidoni, G. L., Fongher, C., Contin, M. L., Cosma, A., Vianello, S., Bondesan, L., Morea, A., Volpi, A., Coracina, A., Panebianco, G., Lombardi, S., Costa, S., Cipponeri, E., Vedovato, M., Scotton, R., Monciotti, C. M., Galderisi, A., Dalfra, M. G., Lapolla, A., Zanon, M., Lisato, G., Mollo, F., Calcaterra, F., Miola, M., Paccagnella, A., Sambataro, M., Moro, E., Trombetta, M., Negri, C., Sabbion, A., Maffeis, C., Strazzabosco, M., Mesturino, C. A., Mingardi, R., Bruttomesso, D, Laviola, L, Lepore, G, Bonfanti, R, Bozzetto, L, Corsi, A, Di Blasi, V, Girelli, A, Grassi, G, Iafusco, D, Rabbone, I, Schiaffini, R, Montani, V, Colleluori, P, Paciotti, V, Alfidi, P, Grosso, J, Tumini, S, Cipriano, P, Vitacolonna, E, Di Vieste, G, Minnucci, A, Antenucci, D, La Penna, G, Taraborrelli, M, Macerala, B, Citro, G, De Morelli, G, Gnasso, A, Irace, C, Citriniti, F, Lazzaro, N, Bruzzese, M, Mammi, F, De Berardinis, F, Santoro, E, Corigliano, G, Corigliano, M, Parillo, M, Schettino, M, Fresa, R, Annuzzi, G, Bassi, V, Santinelli, C, Buono, P, Mozzillo, E, De Feo, E, Esposito, K, Petrizzo, M, Foglia, A, Gatti, A, Gentile, S, Guarino, G, Zanfardino, A, Lambiase, C, Vitale, A, Zucchini, S, Maltoni, G, Forlani, G, Moscatiello, S, Suprani, T, Bensa, M, Tomasi, F, Monesi, M, Nizzoli, M, Acquati, S, Chierici, G, Milli, B, Iughetti, L, Predieri, B, Cavani, R, Romano, S, Manicardi, V, Michelini, M, Cimicchi, M, Ugolotti, D, Zavaroni, I, Dei Cas, A, Dall'Aglio, E, Papi, M, Tardio, S, Calderini, M, Riboni, S, D'Amato, L, Zavaroni, D, Gastaldi, L, Di Bartolo, P, Pellicano, F, Cirillo, A, Graziani, V, Di Secli, C, Amarri, S, Lasagni, A, Marsciani, A, Pedini, A, Pagliani, U, Rossi, C, Tortul, C, Brunato, B, Assaloni, R, Zanette, G, Livolsi, P, Petrucco, A, Tercelj, K, Manca, E, Candido, R, Tommasi, E, Tornese, G, Faleschini, E, Tonutti, L, Agus, S, Zanatta, M, Rosolen, A, Comici, A, Graziano, F, Misischi, I, Pozzilli, P, Maurizi, A, Falasca, P, Tuccinardi, F, Ricciardi, G, Di Masa, P, Ragonese, M, Cipolloni, L, Buzzetti, R, Moretti, C, Leto, G, Crino, A, Bocchini, S, Di Perna, P, Giuliano, M, Frontoni, S, Malandrucco, I, Pitocco, D, Scalpone, R, Toscanella, F, Cappa, M, Ventura, C, Bonato, V, De Bernardinis, M, Cavallo, M, Leonetti, F, Morano, S, Mandosi, E, Cicconetti, E, Ciampittiello, G, Marini, M, Sabato, D, Napoli, A, Giraudo, F, Toscano, V, Massimiani, F, Fava, D, Gargiulo, P, Mecca, N, Tubili, C, Nardone, M, Morviducci, L, Manca-Bitti, M, Arcano, S, Leotta, S, Suraci, C, Chiaramonte, F, Visalli, N, Forte, E, Palmacci, C, Arnaldi, C, Tosini, D, Querci, F, Trevisan, R, Bonfadini, S, Prandi, E, Felappi, B, Locatelli, F, Fuso, V, Rocca, A, Meneghini, E, Massafra, C, Terni, T, Elli, P, Ruggeri, P, Carrai, E, Musacchio, N, Lovagnini Scher, C, Marelli, G, Vilei, V, Richini, D, Inversini, C, Franzetti, I, Bonacina, M, Ciucci, A, Sciangula, L, Duratorre, E, Bonomo, M, Bertuzzi, F, Chebat, E, Muratori, M, Scaramuzza, A, Zuccotti, G, Bollati, P, Colapinto, P, Orsi, E, Palmieri, E, Laurenzi, A, Molinari, C, Frontino, G, Veronelli, A, Zecchini, B, Bianchi, A, Torchio, G, Lovati, E, Ghilardi, G, Dagani, R, Carugo, D, Berra, C, Favacchio, G, Fochesato, E, Pissarelli, A, Bucciarelli, L, Bulgheroni, M, Guerraggio, L, Zonca, S, Bossi, A, Berzi, D, Mangone, I, Cazzaniga, E, Rabini, R, Boemi, M, Faloia, E, Boscaro, M, Sternari, G, Iannilli, A, Cherubini, V, Busciantella Ricci, N, Cartechini, M, Tesei, A, Maolo, G, Galetta, M, Vespasiani, G, Tinti, G, Manfrini, S, Aiello, A, Di Vincenzo, S, Vitale, C, Di Caro, P, Lera, R, Secco, A, Lesina, A, Romeo, F, Origlia, C, Giorda, C, Chiambretti, A, Fornengo, R, De Donno, V, Gallarotti, F, Manti, R, Marafetti, L, Cadario, F, Savastio, S, Barbieri, P, Massucco, P, Ali, A, Gottero, C, Degiovanni, M, Bertaina, S, Maghenzani, G, Tinti, D, Fontana, F, Giorgino, F, Stefanelli, G, Cavallo, L, Zecchino, C, Piccinno, E, Ortolani, F, Gallo, F, Moramarco, F, Marino, A, Sparasci, G, Mileti, G, Lamacchia, O, Picca, G, Coccioli, M, Micale, F, Serra, R, Romano, I, Savino, T, De Cosmo, S, Rauseo, A, Delvecchio, M, Lapolla, R, Braione, A, Papagno, G, Baroni, M, Melis, M, Cossu, E, Songini, M, Cambuli, V, Lo Presti, D, Timpanaro, T, Chiavetta, A, Garofalo, M, Tommaselli, L, Tumminia, A, Scarpitta, A, Di Benedetto, A, Giunta, L, Lombardo, F, Salzano, G, Cardella, F, Roppolo, R, Provenzano, V, Fleres, M, Migliorini, S, De Luca, A, Leopardi, A, Beltrami, C, Toni, S, Guasti, G, Lenzi, L, Lamanna, C, Mannucci, E, Lucchesi, S, Dicianni, G, Aragona, M, Del Prato, S, Fattor, B, Eisath, J, Pasquino, B, Reinstadler, P, Kaufmann, P, Incelli, G, Rauch, S, Romanelli, T, Cauvin, V, Franceschi, R, Soldani, C, Scattoni, R, Norgiolini, R, Celleno, R, Torlone, E, Bolli, G, Lalli, C, Scarponi, M, Bobbio, A, Bechaz, M, Pianta, A, Marangoni, A, Arico, C, Alagona, C, Confortin, L, Rossi, E, Boscolo Bariga, A, Nogara, A, Bettio, M, Frison, V, Guidoni, G, Fongher, C, Contin, M, Cosma, A, Vianello, S, Bondesan, L, Morea, A, Volpi, A, Coracina, A, Panebianco, G, Lombardi, S, Costa, S, Cipponeri, E, Vedovato, M, Scotton, R, Monciotti, C, Galderisi, A, Dalfra, M, Lapolla, A, Zanon, M, Lisato, G, Mollo, F, Calcaterra, F, Miola, M, Paccagnella, A, Sambataro, M, Moro, E, Trombetta, M, Negri, C, Sabbion, A, Maffeis, C, Strazzabosco, M, Mesturino, C, Mingardi, R, Bruttomesso, Daniela, Laviola, Luigi, Lepore, Giuseppe, Bonfanti, Riccardo, Bozzetto, Lutgarda, Corsi, Andrea, Di Blasi, Vincenzo, Girelli, Angela, Grassi, Giorgio, Iafusco, Dario, Rabbone, Ivana, Schiaffini, Riccardo, and Tornese, Gianluca

Subjects
Blood Glucose, Male, Pediatrics, Glucose control, IMPACT, Cost-Benefit Analysis, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, CHILDREN, Practice Patterns, Infusions, Subcutaneous, law.invention, Settore MED/13, Endocrinology, Randomized controlled trial, law, Surveys and Questionnaires, Insulin, Practice Patterns, Physicians', Child, Adult, Diabetes Mellitus, Type 1, Female, Guideline Adherence, Health Care Surveys, Humans, Hypoglycemic Agents, Italy, Medical Laboratory Technology, Medicine (all), PUMP THERAPY, Subcutaneous, Diabetes, Diabetes and Metabolism, TERM METABOLIC-CONTROL, Human, Type 1, Infusions, medicine.medical_specialty, Keywords KeyWords Plus:TERM METABOLIC-CONTROL, BOLUS CALCULATOR, PEDIATRIC-PATIENTS, CONTROLLED-TRIAL, CSII, Diabetes mellitus, Diabetes Mellitus, medicine, term metabolic-control, bolus calculator, pump therapy, pediatric-patients, controlled-trial, children, impact CSII, Glucose sensors, Cost-Benefit Analysi, Intensive care medicine, Type 1 diabetes, Physicians', Hypoglycemic Agent, business.industry, medicine.disease, Subcutaneous insulin, Infusions, Subcutaneou, Multicenter study, Health Care Survey, business
Abstract

Background: Continuous subcutaneous insulin infusion (CSII) is increasing worldwide, mostly because of improved technology. The aim of this study was to evaluate the current status of CSII in Italy. Materials and Methods: Physicians from 272 diabetes centers received a questionnaire investigating clinical features, pump technology, and management of patients on CSII. Results: Two hundred seventeen centers (79.8%) joined the study and, by the end of April 2013, gave information about 10,152 patients treated with CSII: 98.2% with type 1 diabetes mellitus, 81.4% adults, 57% female, and 61% with a conventional pump versus 39% with a sensor-augmented pump. CSII advanced functions were used by 68% of patients, and glucose sensors were used 12 days per month on average. Fifty-eight percent of diabetes centers had more than 20 patients on CSII, but there were differences among centers and among regions. The main indication for CSII was poor glucose control. Dropout was mainly due to pump wearability or nonoptimal glycemic control. Twenty-four hour assistance was guaranteed in 81% of centers. A full diabetes team (physician+ nurse + dietician + psychologist) was available in 23% of adult-care diabetes centers and in 53%of pediatric diabetes units. Conclusions: CSII keeps increasing in Italy. More work is needed to ensure uniform treatment strategies throughout the country and to improve pump use.

Published
2015

14. Quality of life and treatment satisfaction in adults with Type 1 diabetes: a comparison between continuous subcutaneous insulin infusion and multiple daily injections

Author

A. Nicolucci, A. Maione, M. Franciosi, R. Amoretti, E. Busetto, F. Capani, D. Bruttomesso, P. Di Bartolo, A. Girelli, F. Leonetti, L. Morviducci, P. Ponzi, E. Vitacolonna, L. V. Cassano, N. Tota, V. Cherubini, A. Iannilli A. Corsi, P. Ponzani, V. Montani, P. Di Berardino, M. Velussi, F. Giorgino, V. Gigantelli, G. Beltramello, A. Pianta, R. Trevisan, G. Lepore, G. Forlani, G. Marchesini, D. Crazzolara, M. Marchesi, E. Zarra, B. Agosti, G. Careddu, L. Tomaselli, R. Vigneri, M. Agrusta, V. Di Blasi, S. Tumini, M. T. Anzellotti, P. Ruggeri, P. Foglini, M. Rossana, A Murri, S. Toni, M. F. Reali, M. Nizzoli, S. Aquati, G. d’Annunzio, N. Minuto, L. Cataldi, C. Bordone, R. Iannarelli, F. Sciarretta, M. Tagliaferri, M. A. Lezzi, L. Sciangula, A. Ciucci, M. Bonomo, E. Meneghini, G. Mariani, P. Colapinto, G. Testori, P. Rampini, R. Bonfanti, F. Meschi, G. Galimberti, A. Laurenzi, A. Veronelli, C. Mauri, C. Tortul, A. M. Cernigoi, M. E. De Feo, M. Piscopo, G. Annuzzi, L. Bozzetto, A. Franzese, P. Buono, S. Turco, A. Turco, F. Prisco, D. Iafusco, M. Trovati, P. Massucco, S. Costa, M, V. Provenzano, L. Strazzera, G. Ridola, E. Torlone, M. Orsini Federici, A. Bertolotto, M. Aragona, F. Pellicano, V. Manicardi, M. Michelini, M. Parenti, A. C. Babini, P. Borboni, A. Di Flaviani, M. L. Manca Bitti, S. Piccinini, A. Clementi, C. Tubili, C. Suraci, S. Carletti, A. Moretti, M. Maiello, V. C. Iannucci, N. Sulli, B. Shashaj, D. Fava, F. Massimiani, P. Pozzilli, S. Manfrini, C. Landi, I. Tanganelli, G. Grassi, M. Tomelini, R. De Luca, L. Corgiat Mansin, R. Candido, E. Manca, L. Tonutti, C. Noacco, I. Franzetti, P. Marnini., Nicolucci, A., Maione, A., Franciosi, M., Amoretti, R., Busetto, E., Capani, F., Bruttomesso, D., Di Bartolo, P., Girelli, A., Leonetti, F., Morviducci, L., Ponzi, P., Vitacolonna, E., Cassano, L. V., Tota, N., Cherubini, V., Corsi, A. Iannilli A., Ponzani, P., Montani, V., Di Berardino, P., Velussi, M., Giorgino, F., Gigantelli, V., Beltramello, G., Pianta, A., Trevisan, R., Lepore, G., Forlani, G., Marchesini, G., Crazzolara, D., Marchesi, M., Zarra, E., Agosti, B., Careddu, G., Tomaselli, L., Vigneri, R., Agrusta, M., Di Blasi, V., Tumini, S., Anzellotti, M. T., Ruggeri, P., Foglini, P., Rossana, M., Murri, A, Toni, S., Reali, M. F., Nizzoli, M., Aquati, S., D’Annunzio, G., Minuto, N., Cataldi, L., Bordone, C., Iannarelli, R., Sciarretta, F., Tagliaferri, M., Lezzi, M. A., Sciangula, L., Ciucci, A., Bonomo, M., Meneghini, E., Mariani, G., Colapinto, P., Testori, G., Rampini, P., Bonfanti, R., Meschi, F., Galimberti, G., Laurenzi, A., Veronelli, A., Mauri, C., Tortul, C., Cernigoi, A. M., De Feo, M. E., Piscopo, M., Annuzzi, G., Bozzetto, L., Franzese, A., Buono, P., Turco, S., Turco, A., Prisco, F., Iafusco, D., Trovati, M., Massucco, P., Costa, S., M, Provenzano, V., Strazzera, L., Ridola, G., Torlone, E., Orsini Federici, M., Bertolotto, A., Aragona, M., Pellicano, F., Manicardi, V., Michelini, M., Parenti, M., Babini, A. C., Borboni, P., Di Flaviani, A., Manca Bitti, M. L., Piccinini, S., Clementi, A., Tubili, C., Suraci, C., Carletti, S., Moretti, A., Maiello, M., Iannucci, V. C., Sulli, N., Shashaj, B., Fava, D., Massimiani, F., Pozzilli, P., Manfrini, S., Landi, C., Tanganelli, I., Grassi, G., Tomelini, M., De Luca, R., Corgiat Mansin, L., Candido, R., Manca, E., Tonutti, L., Noacco, C., Franzetti, I., and Marnini., P.

Subjects
multiple daily injections, Insulin pump, Adult, Male, medicine.medical_specialty, Continuous subcutaneous insulin infusion, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Injections, Subcutaneous, Insulin Glargine, Endocrinology, Patient satisfaction, Insulin Infusion Systems, Quality of life, Internal medicine, Diabetes mellitus, Internal Medicine, medicine, Humans, Hypoglycemic Agents, Insulin, Multiple daily injection, continuous subcutaneous insulin infusion, quality of life, questionnaires, type 1 diabetes, Type 1 diabetes, Questionnaire, Insulin glargine, business.industry, Middle Aged, medicine.disease, Obesity, Surgery, Insulin, Long-Acting, Diabetes Mellitus, Type 1, Patient Satisfaction, Quality of Life, Female, business, Epidemiologic Methods, medicine.drug
Abstract

Aims The aim of this case–control study was to compare quality of life (QoL) and treatment satisfaction in adults with Type 1 diabetes (T1DM) treated with either continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI). Methods Consecutive patients aged between 18 and 55 years, and attending diabetes clinics for a routine visit, completed the Diabetes-Specific Quality-of-Life Scale (DSQOLS), the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the SF-36 Health Survey (SF-36). Case (CSII) and control subjects (MDI) were recruited in a 1 : 2 ratio. Results Overall, 1341 individuals were enrolled by 62 diabetes clinics; 481 were cases and 860 control subjects. Cases had a longer diabetes duration and were more likely to have eye and renal complications. Age, school education, occupation and HbA 1c were similar. Of control subjects, 90% followed glargine-based MDI regimens and 10% used NPH-based MDI regimens. On multivariate analysis, after adjusting for socioeconomic and clinical characteristics, scores in the following areas of the DSQOLS were higher in cases than control subjects: diet restrictions ( β = 5.96; P < 0.0001), daily hassles ( β = 3.57; P = 0.01) and fears about hypoglycaemia ( β = 3.88; P = 0.006). Treatment with CSII was also associated with a markedly higher DTSQ score ( β = 4.13; P < 0.0001) compared with MDI. Results were similar when CSII was compared separately with glargine- or NPH-based MDI regimens. Conclusions This large, non-randomized, case–control study suggests quality of life gains deriving from greater lifestyle flexibility, less fear of hypoglycaemia, and higher treatment satisfaction, when CSII is compared with either glargine-based or NPH-based MDI regimens. Diabet. Med. 25, 213–220 (2008)

Published
2008

15. Outcome of pregnancy in type 1 diabetic patients treated with insulin lispro or regular insulin: an Italian experience

Author

R. Gentilella, Aldo Galluzzo, R. Spezia, Domenico Valle, G. Di Cianni, L. Scaldaferri, Elena Parretti, M. Songini, Claudia Santini, Roberto Anichini, Matteo Bonomo, Angela Napoli, G. Noacco, Annunziata Lapolla, L. Tonutti, M. G. Dalfrà, Andrea Rossi, Guido Menato, E. Scaldaferri, Elisabetta Torlone, Giorgio Mello, I. Franzetti, Daniela Bruttomesso, LAPOLLA A, DALFRÀ MG, SPEZIA R, ANICHINI R, BONOMO M, BRUTTOMESSO D, DI CIANNI G, FRANZETTI I, GALLUZZO A, MELLO G, MENATO G, NAPOLI A, NOACCO G, PARRETTI E, SANTINI C, SCALDAFERRI E, SCALDAFERRI L, SONGINI M, TONUTTI L, TORLONE E, GENTILELLA R, ROSSI A, and VALLE D

Subjects
medicine.medical_specialty, Pediatrics, neonatal mortality, endocrine system diseases, Endocrinology, Diabetes and Metabolism, Birth weight, Endocrinology, Pregnancy, Internal medicine, Diabetes mellitus, Internal Medicine, Birth Weight, Humans, Hypoglycemic Agents, Insulin, Medicine, Insulin lispro, Chromatography, High Pressure Liquid, Retrospective Studies, Glycated Hemoglobin, Type 1 diabetes, Insulin Lispro, diabetes, business.industry, Infant, Newborn, nutritional and metabolic diseases, Retrospective cohort study, General Medicine, medicine.disease, malformations, pregnancy, Pregnancy Complications, Diabetes Mellitus, Type 1, Italy, Infant, Small for Gestational Age, Regular insulin, Small for gestational age, Female, business, medicine.drug
Abstract

Some studies have shown that fetal outcome observed in patients using insulin lispro is much the same as in pregnant women using regular insulin. This study aims to analyze the Italian data emerging from a multinational, multicenter, retrospective study on mothers with type 1 diabetes mellitus before pregnancy, comparing those treated with insulin lispro for at least 3 months before and 3 months after conception with those treated with regular insulin. The data collected on pregnant women with diabetes attending 15 Italian centers from 1998 to 2001 included: HbA1c at conception and during the first and third trimesters, frequency of severe hypoglycemic episodes, spontaneous abortions, mode and time of delivery, fetal malformations and mortality. Seventy-two diabetic pregnancies treated with lispro and 298 treated with regular insulin were analyzed, revealing a trend towards fewer hypoglycemic episodes in the former, who also had a significantly greater reduction in HbA1c during the first trimester. The rate of congenital malformations was similar in the offspring of the two groups of women treated with insulin lispro or regular insulin. These findings suggest that insulin lispro could be useful for the treatment of hyperglycemia in type 1 diabetic pregnant women.

Published
2008

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