Diabetes mellitus type one Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
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
Sponsors
Disetronic Medical Systems AG (Switzerland)
Eligibility
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Poor motivation 2. Body Mass Index (BMI) greater than 30 kg/m^2 3. Treatment with daily insulin injections 4. Inability to handle pump therapy (pump handling, infusion set handling, compliance with treatment rules) 5. Untreated retinopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose variability as measure by standard deviation of mean blood glucose. Data of the last month of each treatment period were analysed. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed