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.

Roche

Status

Completed

Conditions

Diabetes Mellitus Type 2, Diabetes Mellitus Type 1

Treatments

Device: Accu-Chek FlexLink Plus

Device: Accu-Chek FlexLink

Study type

Interventional

Funder types

Industry

Identifiers

NCT02103595

RD001494

Details and patient eligibility

About

German Multi-centered, randomized, crossover study in diabetic patients evaluating two infusion sets under real life conditions at home. Subjects will be randomized to use one of the infusion set devices during the first period of 4 weeks, and be switched to the other infusion set for the second period of 4 weeks.

Enrollment

80 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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