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.

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 2, Diabetes Mellitus Type 1
• Interventions: Device: Accu-Chek FlexLink; Device: Accu-Chek FlexLink Plus

• Registration Number: NCT02103595
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-01
• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-04
• Primary Completion: 2014-06-30
• Study Completion: 2014-06-30
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Accu-Chek FlexLink Plus cross over to Accu-Chek FlexLink	Accu-Chek FlexLink	-
Accu-Chek FlexLink Plus cross over to Accu-Chek FlexLink	Accu-Chek FlexLink Plus	-
Accu-Chek FlexLink cross over to Accu-Chek FlexLink Plus	Accu-Chek FlexLink	-
Accu-Chek FlexLink cross over to Accu-Chek FlexLink Plus	Accu-Chek FlexLink Plus	-

Primary Outcome Measures

Name	Time	Method
Perception of pain during infusion set insertion assessed by means of a visual analogue scale (VAS)	8 weeks

Secondary Outcome Measures

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