Reduction of severe hypoglycaemia with continuous intraperitoneal insulin infusion in type one diabetic patients unsuccessfully treated by continuous subcutaneous insulin infusio

Completed

Conditions: Diabetes mellitus type one
Nutritional, Metabolic, Endocrine
Diabetes mellitus

Registration Number: ISRCTN68954085

Lead Sponsor: Disetronic Medical Systems AG (Switzerland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 62

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Frequency of severe hypoglycaemias (defined by hospitalisation, unconsciousness, seizures or intravenous glucose administration)<br>2. Metabolic control (HbA1c, blood glucose, blood glucose fluctuations)<br>3. Quality of life (DQoL)<br>4. Safety of CIPII with DiaPort in comparison to CSII