Clinical trial NCT01483352: Evaluation of Accu-Chek DiaPort, a Port System for Continuous Intraperitoneal Insulin Infusion, in Patients With Type I Diabetes
Official title: Evaluation of Accu-Chek DiaPort, a Port System for Continuous Intraperitoneal Insulin Infusion, in Patients With Type I Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-12-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Accu-Chek DiaPort system enables continuous intraperitoneal insulin infusion (CIPII): that is, infusion of insulin into the peritoneal cavity using an Accu-Chek insulin pump and an infusion set. The Accu-Chek DiaPort consists of a metal body with a catheter that is placed in the abdomen. The opening of the port is raised above the surface of the skin about 5 millimeters, while a flower-shaped plate is placed under the skin, providing stability for the port. The port has been designed for those diabetics who cannot benefit fully from subcutaneous insulin infusion. The primary objective of the study is to assess the suitability of Accu-Chek DiaPort to perform continuous intraperitoneal insulin delivery. The data collection focuses on the condition of tissue around the port after the implantation, possible peritoneal reactions to the port system, and the peritoneal delivery of insulin. Secondary objectives are the assessments of therapeutic performance and successful implementation of design requirements. In total 12 Patients will participate in this open, mono-centre, single-arm, interventional clinical trial. The study lasts 9 months (without run in period of 3 to 1 week) separated in two parts. Phase I last 12 weeks. Phase II last 6 month until the end of the study. During the study, seven visits are planned. The screening visit can take place up to 3 weeks before study start. At the implantation visit which can last up to 5 days the port will be implanted. After the implantation insulin therapy will be adjusted for CIPII and the patients will be trained for handling and daily care of the Accu-Chek DiaPort system. To check the functionality of the system, the first control visit will take place 2 weeks and the second control visit 6 weeks after the implantation. At the week 12 visit, the most important parameters will be collected for the phase I report. The following visits take place 6 and 9 months after the implantation.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>= 18 years of age at the time of the screening visit
* Type 1 diabetes mellitus
* On CSII therapy for at least 6 months prior to the screening visit
* Has been unsuccessfully treated with standard subcutaneous insulin therapy including CSII therapy, as defined by frequent (defined as handicapping in daily life) or severe (needing help from a third party) hypoglycemia and/or HbA1c above 8.5%, and/or other medical indication for CIPII therapy
* Presence of at least one of the following indications for CIPII therapy: - Frequent (defined as handicapping daily life) hypoglycemia during CSII therapy - Severe hypoglycemia (needing help from a third party) during CSII therapy - HbA1c above 8.5% during CSII therapy - Hypoglycemia unawareness during CSII therapy - Real subcutaneous insulin resistance - Insulin-induced lipoatrophy - Insulin-associated lipohypertrophy not controlled by site rotation - Other skin disorders interfering with the subcutaneous route of administration - Marked fluctuations of glucose levels and insulin requirements during CSII therapy- History of allergies to materials required for subcutaneous insulin therapy
* Performs usually self-management of blood glucose at least 4 times per day
* Willing to adhere to the study visit schedule and motivated to undergo the therapy

Exclusion Criteria:

* Presence of marked peritoneal adhesions or scarring after abdominal surgery
* Disorders of the gastrointestinal tract, respectively the digestive system potentially interfering with the intraperitoneal route of administration (e.g. presence of marked peritoneal adhesions, or colonic disease)
* Known high levels of anti-insulin antibodies
* History of allergy to materials used for the Accu-Chek DiaPort (titanium, polyethylene)
* Severely impaired immune response
* Uses systemic oral or inhaled steroids for \> 14 days within the last 3 months
* Pregnant or lactating women, or women currently planning a pregnancy
* Previous history of severe chronic liver disease defined as signs of portal hypertension and/or Quick's value below 50% in spite of vitamin K administration
* Subject is treated for malignancy (chemotherapy, radiation or other treatment) (self-reported)
* Positive for HIV infection
* Is under CAPD treatment
* Suffers from severe eating disorders like bulimia or anorexia
* Alcohol or drug abuse
* Serious psychological disorders like schizophrenia, depression, Münchhausen's syndrome etc.
* Presence of known or suspected infections, bacteremia, septicemia or peritonitis
* Participation in a clinical trial (medicinal, medical device) within the last 30 days prior to screening

Primary outcomes:
measure: Suitability of the Device - Overall Suitability Score
timeFrame: Week 12
measure: Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin
timeFrame: Weeks 2 and 12 and Months 6, 9, 12 and 15
measure: Percentage of Participants With Dislocation of Port
timeFrame: Weeks 2 and 12 and Months 6, 9, 12 and 15
measure: Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port
timeFrame: Weeks 2 and 12 and Months 6, 9, 12 and 15
measure: Percentage of Participants With Signs of Infection in the Tissue Around the Port
timeFrame: Weeks 2 and 12 and Months 6, 9, 12 and 15
measure: Percentage of Participants With Signs of Pain in the Tissue Around the Port
timeFrame: Weeks 2 and 12 and Months 6, 9, 12 and 15
measure: Percentage of Participants With Persistent Dull Pain Due to Catheter
timeFrame: Weeks 2 and 12 and Months 6, 9, 12 and 15
measure: Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant
timeFrame: Weeks 2 and 12 and Months 6, 9, 12 and 15
measure: Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally
timeFrame: Weeks 2 and 12 and Months 6, 9, 12 and 15
Secondary outcomes:
measure: Insulin Doses Dispensed From Insulin Pump
timeFrame: Screening, Week 12 and Months 6, 9 and 12
measure: Hemoglobin A1c Levels
timeFrame: Screening, Week 12 and Months 6, 9 and 12
measure: Self Monitored Blood Glucose Levels
timeFrame: Screening, Week 12 and Months 6, 9 and 12
measure: Continuous Glucose Measurement (CGM) - Glucose Levels
timeFrame: Screening, Week 12 and 6 Months
measure: Glycemic Variability: Percent Coefficient of Variation in Blood Glucose
timeFrame: Screening, Week 12 and Months 6, 9 and 12
measure: Percentage of Participants Achieving Target Glucose Levels
timeFrame: Screening, Week 12 and 6 Months
measure: Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response
timeFrame: Week 12
Other outcomes:
Locations:
city: Bad Heilbrunn
country: Germany
Study officials:
affiliation: Roche Diabetes Care AG
name: Barbara Holzer
role: STUDY_DIRECTOR
References: