RESUMEN
AIM: Continuous intraperitoneal insulin infusion (CIPII) with the DiaPort system using regular insulin was compared to continuous subcutaneous insulin infusion (CSII) using insulin Lispro, to investigate the frequency of hypoglycemia, blood glucose control, quality of life, and safety. METHODS: In this open, randomized, controlled, cross-over, multinational, 12-month study, 60 type 1 diabetic patients with frequent hypoglycemia and/or HbA1c > 7.0% with CSII were randomized to CIPII or CSII. The aim was to obtain the best possible blood glucose while avoiding hypoglycemia. RESULTS: The frequency of any hypoglycemia was similar (CIPII 118.2 (SD 82.6) events / patient year, CSII 115.8 (SD 75.7) p = 0.910). The incidence of severe hypoglycemia with CSII was more than twice the one with CIPII (CIPII 34.8 events / 100 patient years, CSII 86.1, p = 0.013). HbA1c, mean blood glucose, and glucose fluctuations were not statistically different. Treatment-related severe complications occurred mainly during CIPII: port infections (0.47 events / patient year), abdominal pain (0.21 events / patient year), insulin underdelivery (0.14 events / patient year). Weight gain was greater with CSII (+ 1.5 kg vs. - 0.1 kg, p = 0.013), quality of life better with CIPII. CONCLUSIONS: In type 1 diabetes CIPII with DiaPort reduces the number of severe episodes of hypoglycemia and improves quality of life with no weight gain. Because of complications, indications for CIPII must be strictly controlled. CIPII with DiaPort is an alternative therapy when CSII is not fully successful and provides an easy method of intraperitoneal therapy.
Asunto(s)
Glucemia/análisis , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hipoglucemia/prevención & control , Hipoglucemiantes/administración & dosificación , Infusiones Parenterales/normas , Sistemas de Infusión de Insulina/normas , Insulina/administración & dosificación , Estudios Cruzados , Diabetes Mellitus Tipo 1/sangre , Europa (Continente) , Femenino , Humanos , Hipoglucemia/sangre , Hipoglucemia/epidemiología , Hipoglucemiantes/sangre , Insulina/análogos & derivados , Insulina/sangre , Insulina Lispro , Masculino , Persona de Mediana Edad , Calidad de Vida , Resultado del TratamientoRESUMEN
One to ten years after laser coagulation for diabetic retinopathy, 229 type I diabetics (mean age 44.3 years) and 157 type II diabetics (mean age 65 years) were re-studied for morbidity and mortality (progression of late damage, duration of survival, cause of death). The duration of diabetes at the first laser coagulation averaged 23.1 years for type I diabetics (15.9 years for type II). Average period from the first laser coagulation to the re-examination was 6.5 years for type I, 5.1 for type II diabetics. Of those patients still alive 6.7% had gone blind (type II: 7.3%). 2.1% and 4.6%, respectively, were receiving dialysis treatment, while renal transplantation had been performed in 3.1 and 1.8%, respectively. Stroke was the most frequent macrovascular complications (8.4 and 16.5%), followed by leg amputation (3.6 and 14.7%) and myocardial infarction (3.7 and 18.3%). 83 patients had died: 35 (15.3%) type I and 48 (30.6%) type II diabetics. Causes of death were septicaemia 14.3% (0%), uraemia 11.4% (8.3%), myocardial infarction 14.3% (33.3%), heart failure 8.6% (29.2%) and stroke 5.7% (6.3%). 10.7% (24.2%) had died within the first 5 years after laser coagulation. Despite a lower incidence of blindness in patients with diabetic retinopathy, the vascular disease progresses in other vascular regions so that a large proportion of diabetics will develop renal failure or die early from macrovascular complications.
Asunto(s)
Diabetes Mellitus Tipo 1/complicaciones , Diabetes Mellitus Tipo 1/mortalidad , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/mortalidad , Retinopatía Diabética/diagnóstico , Adulto , Anciano , Enfermedades Cardiovasculares/etiología , Nefropatías Diabéticas/etiología , Retinopatía Diabética/cirugía , Oftalmopatías/etiología , Estudios de Seguimiento , Humanos , Coagulación con Láser , Persona de Mediana Edad , Factores de TiempoRESUMEN
32 diabetic and 31 metabolic healthy pregnant women are studied to answer the following questions: Is there a difference in the albumin-excretion rate (AER) during the pregnancy in primary normoalbuminuric type 1 diabetics and non-diabetics? Is there a difference 6 months post partum between the 2 groups? The average age of the diabetics (D) is 28, of the non-diabetics (ND) 27 years; the diabetics suffer from diabetes mellitus 12.5 years. In the 16th week of pregnancy, we find a AER (D vs. ND) of 5.0 vs. 2.37 micrograms/min (not significant [n.s.]), creatinin in serum 0.77 vs. 0.75 mg/dl (p < 0.05), creatinin clearance 92.5 vs. 103.4 ml/min (n.s.). In the 28th and in the 34th to 38th week, there is no significant elevation of the AER compared to the 16th week; but there is a significant elevation in the diabetics vs. the non-diabetics. 6 months post partum, the AER (D vs. ND) are: 6.13 vs. 5.11 micrograms/min (n.s. vs. 16th week and D vs. ND); in each group one person is found with a positive microalbuminuria (MA): 48.2 micrograms/min (D) and 27.4 mg/min (ND). Another diabetic woman shows post partum an isolated higher value of creatinin in serum: 1.5 mg/dl (without MA). This parameter is post partum significant higher (0.97 [D], 0.96 [ND] mg/dl) than in the 16th week of pregnancy (0.77 [D], 0.75 [ND] mg/dl). The creatinin clearance decreases post partum (pp): 92.2 ml/min (pp) vs. 102.0 ml/min (28th week) in the diabetics (n.s.) and 80.6 ml/min (pp) vs. 111.0 ml/min (28th week) in the non-diabetics (p < 0.05). Concerning the studied renal parameters, there is a significant difference of the albumin-excretion rates during the pregnancy between preconceptional normoalbuminuric type 1 diabetic and non-diabetic women, but 6 months post partum, there is no significant difference. The diabetics show a significant increase of the creatinin in urine and in serum and no significant change of the creatinin clearance 6 months post partum.