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.
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.
1 other identifier
interventional
80
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 29, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2014
CompletedApril 4, 2017
April 1, 2017
8 months
January 29, 2014
April 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Perception of pain during infusion set insertion assessed by means of a visual analogue scale (VAS)
8 weeks
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Accu-Chek FlexLink Plus cross over to Accu-Chek FlexLink
OTHERAccu-Chek FlexLink cross over to Accu-Chek FlexLink Plus
OTHERInterventions
Insulin pump device used for 4-weeks under real life conditions
Insulin pump device used for 4-weeks under real life conditions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Roche Diagnostics GmbHcollaborator
Study Sites (5)
Unknown Facility
Aschaffenburg, 63739, Germany
Unknown Facility
Berlin, 01627, Germany
Unknown Facility
Berlin, 13597, Germany
Unknown Facility
Rostock, 18057, Germany
Unknown Facility
Ulm, 89081, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Linda Amstutz
Roche Diagnostics GmbH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2014
First Posted
April 4, 2014
Study Start
November 1, 2013
Primary Completion
June 30, 2014
Study Completion
June 30, 2014
Last Updated
April 4, 2017
Record last verified: 2017-04