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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02103595

Enrollment

Registered

2014-04-04

Start date

2013-11-01

Completion date

2014-06-30

Last updated

2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2, Diabetes Mellitus Type 1

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.

Interventions

DEVICEAccu-Chek FlexLink

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

DEVICEAccu-Chek FlexLink Plus

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Pump settings, including insulin dosage	8 weeks
Device satisfaction/preference as assessed by patient surveys	8 weeks
Incidence of kinked cannulas	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026