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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.

Primary Purpose

Diabetes Mellitus Type 2, Diabetes Mellitus Type 1

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Accu-Chek FlexLink

Accu-Chek FlexLink Plus

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus Type 2, Diabetes Mellitus Type 1

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Accu-Chek FlexLink Plus cross over to Accu-Chek FlexLink

Accu-Chek FlexLink cross over to Accu-Chek FlexLink Plus

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of kinked cannulas

Pump settings, including insulin dosage

Device satisfaction/preference as assessed by patient surveys

Investigator assessment of patient device use

Incidence of adverse events

Insulin set replacement pattern

Full Information

NCT ID

NCT02103595

First Posted

January 29, 2014

Last Updated

April 3, 2017

Sponsor

Hoffmann-La Roche

Collaborators

Roche Diagnostics

1. Study Identification

Unique Protocol Identification Number

NCT02103595

Brief Title

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.

Official 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.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

November 1, 2013 (Actual)

Primary Completion Date

June 30, 2014 (Actual)

Study Completion Date

June 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

Collaborators

Roche Diagnostics

4. Oversight

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type 2, Diabetes Mellitus Type 1

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Accu-Chek FlexLink Plus cross over to Accu-Chek FlexLink

Arm Type

Other

Arm Title

Accu-Chek FlexLink cross over to Accu-Chek FlexLink Plus

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

Accu-Chek FlexLink

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Accu-Chek FlexLink Plus

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Incidence of kinked cannulas

Time Frame

8 weeks

Title

Pump settings, including insulin dosage

Time Frame

8 weeks

Title

Device satisfaction/preference as assessed by patient surveys

Time Frame

8 weeks

Title

Investigator assessment of patient device use

Time Frame

At Baseline and Week 4

Title

Incidence of adverse events

Time Frame

8 weeks

Title

Insulin set replacement pattern

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda Amstutz

Organizational Affiliation

Roche Diagnostics

Official's Role

Study Director

Facility Information:

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

City

Berlin

ZIP/Postal Code

01627

Country

Germany

City

Berlin

ZIP/Postal Code

13597

Country

Germany

City

Rostock

ZIP/Postal Code

18057

Country

Germany

City

Ulm

ZIP/Postal Code

89081

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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.

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