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OpenTrials
Completed

NCT Number: 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.

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aschaffenburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accu-Chek FlexLink

Device

Insulin pump device used for 4-weeks under real life conditions

Accu-Chek FlexLink Plus

Device

Insulin pump device used for 4-weeks under real life conditions

Primary outcomes

  1. Perception of pain during infusion set insertion assessed by means of a visual analogue scale (VAS)

    Time frame: 8 weeks

Secondary outcomes

  1. Incidence of kinked cannulas

    Time frame: 8 weeks

  2. Pump settings, including insulin dosage

    Time frame: 8 weeks

  3. Device satisfaction/preference as assessed by patient surveys

    Time frame: 8 weeks

  4. Investigator assessment of patient device use

    Time frame: At Baseline and Week 4

  5. Incidence of adverse events

    Time frame: 8 weeks

  6. Insulin set replacement pattern

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Roche Diagnostics GmbH

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2014
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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