Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/09/2006
Date assigned
15/11/2006
Last edited
08/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes