Diabetes mellitus type one Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
60 type one diabetic patients with frequent hypoglycaemias and/or HbA1c greater than 7.0% with CSII were randomised to CIPII or CSII. The aim was to obtain the best possible blood glucose while avoidi
Sponsors
Disetronic Medical Systems AG (Switzerland)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients at least 18 years of age 2. Type one diabetes 3. Unsuccessfully treated with CSII (i.e. frequent hypoglycaemias according to the assessment of the investigator and/or HbA1c above 7.0%)
Exclusion criteria
Exclusion criteria: 1. Lack of cooperation or of mental capacity 2. Pregnancy or wish for pregnancy 3. Abuse of alcohol or drugs 4. Lack of personal hygiene 5. Frequent change of treating physicians 6. Severe liver disease 7. Current malignant disease 8. Human immunodeficiency virus (HIV) infection 9. Continuous ambulatory peritoneal dialysis 10. Contraindications for anaesthesia or surgical operations 11. Severe eating disorders 12. Severe psychological or psychiatric disorders 13. Lack of willingness to perform at least four blood glucose self-measurements per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study was the frequency of hypoglycaemias (defined as blood glucose below 54 mg/dl [3 mmol/l]) per patient year with CIPII using DiaPort in comparison to CSII with insulin Lispro. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Frequency of severe hypoglycaemias (defined by hospitalisation, unconsciousness, seizures or intravenous glucose administration) 2. Metabolic control (HbA1c, blood glucose, blood glucose fluctuations) 3. Quality of life (DQoL) 4. Safety of CIPII with DiaPort in comparison to CSII | — |
Countries
Austria, France, Germany, Netherlands, Switzerland
Outcome results
None listed