A Study Evaluating the Perception of Insertion Pain With Accu-Chek FlexLink and FlexLink Plus Insulin Pump Devices Under Real Life Conditions in Diabetic Patients.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
With
Roche Diagnostics GmbH
Age
18–99
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female subjects at least 18 years of age
Diabetes mellitus type 1 or type 2
Continuous subcutaneous insulin therapy (CSII) for at least 3 months
Insulin pump compatible with Luer lock infusion set (Accu-Chek, Disetronic, Animas, Deltec Cozmo and Minimed 506 to 508)
Sufficient potential infusion sites suitable for the usage of a cannula length of 8 mm and a tubing length of 70 and 80 cm
Willing to measure blood glucose at least 4 times per day and 1-3 hrs after each new insertion
Willing and able to participate and comply with study procedures including the general recommendation of shifting infusion sets (at least every 3 days)
You may not be if
Significantly impaired awareness of hypoglycemia
A history of or high risk of ketoacidosis during CSII therapy
Frequent catheter abscesses in the past year, as per investigator´s discretion
Known strong plaster incompatibility and/or allergy (history of catheter use)
Unstable chronic disease other than diabetes
Chronic use of steroids in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy
Acute illness or abnormality at the time of screening rendering the patient not suitable to participate in the study in the opinion of the Investigator
Chronic use of analgesics and any other condition interfering with the assessment of pain, as per investigator´s discretion
Are either pregnant or breastfeeding or are currently planning a pregnancy
Clareo Health | A Study Evaluating the Perception of Insertion Pain With Accu-Chek FlexLink and FlexLink Plus Insulin Pump Devices Under Real Life Conditions in Diabetic Patients.
