Comparison between continuous subcutaneous insulin infusion with multiple basal lispro infusion rates and multiple daily insulin injection with lispro and glargine

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2007
INTERVENTION: Patients were randomly assigned to Continuous Subcutaneous Insulin Infusion (CSII) with lispro or Multiple Daily Injections (MDI) with lispro and glargine. After four months they were switched to the alternative treatment. CONDITION: Diabetes mellitus type one ; Nutritional, Metabolic, Endocrine ; Diabetes mellitus PRIMARY OUTCOME: Blood glucose variability as measure by standard deviation of mean blood glucose.; ; Data of the last month of each treatment period were analysed. SECONDARY OUTCOME: 1. HbA1c ; 2. Quality of metablic control characterised by the mean Blood Glucose (BG) during the last month of the respective treatment period; 3. Mean and the standard deviation of the weekly BG (altogether and at the different points in time); 4. Frequency of BG greater than 8.0 mmol/l; 5. Frequency of BG less than 3.5 mmol/l with or without any symptoms of hypoglycaemia; 6. Frequency of severe hypoglycaemia (BG less than 2.0 mmol/l); 7. Frequency of severe hypoglycaemia (BG less than 2.0 mmol/l) day over; 8. Frequency of severe hypoglycaemia (BG less than 2.0 mmol/l) night over; 9. Frequency of Diabetic Ketoacidosis (DKA); 10. Frequency of hospitalisation or the use of an ambulance due to hypoglycaemic or ketotic/ketoacidotic events; 11. Number of daily BG measurements; 12. Daily insulin requirement (basal/preprandial, meal and correction boluses); 13. Number of daily glargine injections; 14. Body weight; 15. Treatment satisfaction measured by Diabetes Treatment Satisfaction Questionnaire (DTSQ); ; Data of the last month of each treatment period were analysed. INCLUSION CRITERIA: 1. Type one diabetic patients (World Health Organisation [WHO] classification) 2. Between 18 and 60 years old 3. Have been diabetics for more than two years 4. Have been treated with CSII for at least six months prior to the study 5. HbA1c needs to be less than 8.5% 6. Patients should be familiar with carbohydrate counting and should be able to change insulin doses (either by pump or injections) based on changes in food intake and physical exercise
Epistemonikos ID: de4c7a89e1ee2416fec6acfbfcd234362fa81262
First added on: Aug 21, 2024