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

ISRCTN	ISRCTN68954085
DOI	https://doi.org/10.1186/ISRCTN68954085
Secondary identifying numbers	N/A

Submission date: 17/09/2006
Registration date: 15/11/2006
Last edited: 08/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andreas Liebl
Scientific

Woernerweg 30
Bad Heilbrunn
83670
Germany

Email	dr.liebl@t-online.de

Study information

Study design	Open, randomised, controlled, cross-over, multinational, 12-month study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study acronym	DiaPort Study
Study objectives	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(s)	Approved by the Ethical Committee of the Bayerische Landesärztekammer in Munich, September 2000.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/10/2000
Completion date	31/12/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	62
Key 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%)
Key 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
Date of first enrolment	01/10/2000
Date of final enrolment	31/12/2001

Locations

Countries of recruitment

Austria
France
Germany
Netherlands
Switzerland

Study participating centre

Woernerweg 30

Bad Heilbrunn
83670
Germany

Sponsor information

Disetronic Medical Systems AG (Switzerland)
Industry

Kirchbergstrasse 190
Burgdorf
CH-3401
Switzerland

Website	http://www.disetronic.com/disetronic.asp?menuId=2&languageId=2
"ROR"	https://ror.org/00by1q217

Funders

Funder type

Industry

Disetronic Medical Systems AG (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan