Clinical trial NCT02103595: 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.
Official title: Perception of Insertion Pain With Soft Cannula Infusion Sets: A Multicenter, Randomized, Cross-over Study to Evaluate Accu-Chek FlexLink Plus and Accu-Chek FlexLink Under Real Life Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2, Diabetes Mellitus Type 1
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Roche Diagnostics GmbH
First posted: 2014-04-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Perception of pain during infusion set insertion assessed by means of a visual analogue scale (VAS)
timeFrame: 8 weeks
Secondary outcomes:
measure: Incidence of kinked cannulas
timeFrame: 8 weeks
measure: Pump settings, including insulin dosage
timeFrame: 8 weeks
measure: Device satisfaction/preference as assessed by patient surveys
timeFrame: 8 weeks
measure: Investigator assessment of patient device use
timeFrame: At Baseline and Week 4
measure: Incidence of adverse events
timeFrame: 8 weeks
measure: Insulin set replacement pattern
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Rostock
country: Germany
city: Ulm
country: Germany
Study officials:
affiliation: Roche Diagnostics GmbH
name: Linda Amstutz
role: STUDY_DIRECTOR
References: