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

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN68954085
• Date of registration: 15/11/2006
• Prospective Registration: No
• Primary sponsor: Disetronic Medical Systems AG (Switzerland)
• Public title: Reduction of severe hypoglycaemia with continuous intraperitoneal insulin infusion in type one diabetic patients unsuccessfully treated by continuous subcutaneous insulin infusion
• Date of first enrolment: 01/10/2000
• Target sample size: 62
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN68954085
• Study type: Interventional
• Study design: Open, randomised, controlled, cross-over, multinational, 12-month study (Treatment)

Countries of recruitment

Austria, France, Germany, Netherlands, Switzerland

Contacts

• Name: Andreas Liebl

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Diabetes mellitus type one
Nutritional, Metabolic, Endocrine
Diabetes mellitus

Intervention(s)

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 avoiding hypoglycaemias.

1. Patients in the CSII group continued their CSII using insulin Lispro
2. Patients in the CIPII group had an implantation of a percutaneous DiaPort system under general anesthesia. The catheter was placed into the peritoneal cavity. The exact localisation of the DiaPort was chosen individually according to the regular habits and clothing of the patients. Mostly the port was implanted into the lower right or left quadrant of the abdomen. CSII was terminated, and the insulin pump was connected to the DiaPort. The insulin dosage was optimised during the stay in hospital and at each visit.

In both treatment groups, the target was to obtain fasting and pre-prandial blood glucose values between 80 - 120 mg/dl, and average blood glucose values below 150 mg/dl, while avoiding hypoglycemias at the same time. Also, in both groups H-TRONplus insulin pumps from Roche Diagnostics were used. For intraperitoneal infusion only regular insulin for pumps (Insuman Infusat® or H-tronin®, Aventis®) was administered.

In both groups, there were regular evaluations of diabetes complications, vital parameters, HbA1c, safety laboratory data (one central laboratory for all study sites), abdominal ultrasound examination, quality of life (using the Diabetes Quality of Life measure [DQoL]), port-related complications, and photographic documentation.

The patients performed and documented at least four blood glucose self measurements daily (prior to each main meal and just before bedtime). Before visits, additional measurements (two hours after each meal and during night time between 2:00 and 3:00 am) were performed.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

Disetronic Medical Systems AG (Switzerland)