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.

April 3, 2017 updated by: Hoffmann-La Roche

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aschaffenburg, Germany, 63739
      • Berlin, Germany, 13597
      • Berlin, Germany, 01627
      • Rostock, Germany, 18057
      • Ulm, Germany, 89081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional 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
Device: Accu-Chek FlexLink
Insulin pump device used for 4-weeks under real life conditions
Device: Accu-Chek FlexLink Plus
Insulin pump device used for 4-weeks under real life conditions
Other: Accu-Chek FlexLink cross over to Accu-Chek FlexLink Plus
Device: Accu-Chek FlexLink
Insulin pump device used for 4-weeks under real life conditions
Device: Accu-Chek FlexLink Plus
Insulin pump device used for 4-weeks under real life conditions

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

Roche Diagnostics

Investigators

  • Study Director: Linda Amstutz, Roche Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

June 30, 2014

Study Completion (Actual)

June 30, 2014

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD001494

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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