Evaluation of Accu-Chek DiaPort, a Port System for Continuous Intraperitoneal Insulin Infusion, in Patients With Type I Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Hoffmann-La Roche.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01483352
First received: November 15, 2011
Last updated: August 15, 2012
Last verified: November 2011
  Purpose

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 nine month (without run in period of 3 to 1 week) separated in two parts. Phase I last 12 weeks. Phase II last six month until the end of the study. During the study, seven visits are planned. The screening visit can take place up to three weeks before study start. At the implantation visit which can last up to five 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 two weeks and the second control visit six weeks after the implantation. At the visit week 12 the most important parameters will be collected for the phase I report. The following visits take place six and nine month after the implantation.


Condition Intervention
Diabetes Mellitus, Type 1
Device: Accu-Chek DiaPort

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Accu-Chek DiaPort, a Port System for Continuous Intraperitoneal Insulin Infusion, in Patients With Type I Diabetes

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Conditions of tissue around port: Tight connection between port and skin/signs of redness, swelling,infection [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Peritoneal reactions: Persistent dull pain/infection/allergic reaction [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Ability to deliver insulin intraperitoneally (delivery of insulin using insulin pump, infusion set and port system assessed by rating scale) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HbA1c [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
  • Glycemic variability during continuous glucose monitoring: Change of coefficient of variation measured over minumum 3 days [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in mean glucose during continuous glucose monitoring [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in total daily insulin dose from insulin pump (mean per day measured over 7 days) [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
  • Incidence of severe hypoglycemia [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: November 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Device: Accu-Chek DiaPort

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483352

Locations
Germany
Bad Heilbrunn, Germany, 83670
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Barbara Holzer Roche Diabetes Care AG
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01483352     History of Changes
Other Study ID Numbers: RD001211
Study First Received: November 15, 2011
Last Updated: August 15, 2012
Health Authority: Germany: BfArM Bundesinstitut für Arzneimittel und Medizinprodukte

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014