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.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Diabetes Mellitus Type 2, Diabetes Mellitus Type 1

Intervention / Treatment
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* Device: Accu-Chek FlexLink
* Device: Accu-Chek FlexLink Plus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Accu-Chek FlexLink Plus cross over to Accu-Chek FlexLink<br> | Device: Accu-Chek FlexLink<br>* Insulin pump device used for 4-weeks under real life conditions<br>Device: Accu-Chek FlexLink Plus<br>* Insulin pump device used for 4-weeks under real life conditions<br>|
| Other: Accu-Chek FlexLink cross over to Accu-Chek FlexLink Plus<br> | Device: Accu-Chek FlexLink<br>* Insulin pump device used for 4-weeks under real life conditions<br>Device: Accu-Chek FlexLink Plus<br>* Insulin pump device used for 4-weeks under real life conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of pain during infusion set insertion assessed by means of a visual analogue scale (VAS) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of kinked cannulas |  | 8 weeks | 
| Pump settings, including insulin dosage |  | 8 weeks | 
| Device satisfaction/preference as assessed by patient surveys |  | 8 weeks | 
| Investigator assessment of patient device use |  | At Baseline and Week 4 | 
| Incidence of adverse events |  | 8 weeks | 
| Insulin set replacement pattern |  | 8 weeks |