Status:
COMPLETED
Evaluation of Accu-Chek DiaPort, a Port System for Continuous Intraperitoneal Insulin Infusion, in Patients With Type I Diabetes
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
NA
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. T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01483352
Start Date
November 1 2011
End Date
March 1 2013
Last Update
April 15 2016
Active Locations (1)
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1
Bad Heilbrunn, Germany, 83670