Contact information
Type
Scientific
Primary contact
Dr Andreas Liebl
ORCID ID
Contact details
Woernerweg 30
Bad Heilbrunn
83670
Germany
dr.liebl@t-online.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
DiaPort Study
Study hypothesis
Objective:
Continuous intraperitoneal insulin infusion (CIPII) with the DiaPort system using regular insulin was compared to continuous subcutaneous insulin infusion (CSII) using insulin Lispro, to investigate the frequency of hypoglycaemias, blood glucose control, quality of life, and safety.
Ethics approval
Approved by the Ethical Committee of the Bayerische Landesärztekammer in Munich, September 2000.
Study design
Open, randomised, controlled, cross-over, multinational, 12-month study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Diabetes mellitus type one
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Insulin Infusion
Primary outcome measure
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
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
Overall trial start date
01/10/2000
Overall trial end date
31/12/2001
Reason abandoned (if study stopped)
Eligibility
Participant 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%)
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
62
Participant 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
Recruitment start date
01/10/2000
Recruitment end date
31/12/2001
Locations
Countries of recruitment
Austria, France, Germany, Netherlands, Switzerland
Trial participating centre
Woernerweg 30
Bad Heilbrunn
83670
Germany
Sponsor information
Organisation
Disetronic Medical Systems AG (Switzerland)
Sponsor details
Kirchbergstrasse 190
Burgdorf
CH-3401
Switzerland
Sponsor type
Industry
Website
http://www.disetronic.com/disetronic.asp?menuId=2&languageId=2
Funders
Funder type
Industry
Funder name
Disetronic Medical Systems AG (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list