A reduction in severe hypoglycaemia in type 1 diabetes in a randomized crossover study of continuous intraperitoneal compared with subcutaneous insulin infusion

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 t...

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Bibliographic Details
Published in:Diabetes, obesity & metabolism obesity & metabolism, 2009-11, Vol.11 (11), p.1001-1008
Main Authors: Liebl, A., Hoogma, R., Renard, E., Geelhoed-Duijvestijn, P. H. L. M., Klein, E., Diglas, J., Kessler, L., Melki, V., Diem, P., Brun, J.-M., Schaepelynck-Bélicar, P., Frei, T.
Format: Article
Language:English
Subjects:
Blood Glucose - analysis
clinical trials
Cross-Over Studies
diabetes mellitus
Diabetes Mellitus, Type 1 - blood
Diabetes Mellitus, Type 1 - drug therapy
diabetes treatment
Endocrinology and metabolism
Europe
Female
Human health and pathology
Humans
Hypoglycemia - blood
Hypoglycemia - epidemiology
Hypoglycemia - prevention & control
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - blood
Infusions, Parenteral - standards
Insulin - administration & dosage
Insulin - analogs & derivatives
Insulin - blood
Insulin Infusion Systems - standards
Insulin Lispro
insulin pump therapy
intraperitoneal insulin therapy
Life Sciences
Male
Middle Aged
Quality of Life
Treatment Outcome
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Summary: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.
ISSN:1462-8902
1463-1326
DOI:10.1111/j.1463-1326.2009.01059.x