Diabetes Mellitus Type 2, Diabetes Mellitus Type 1NCT02103595
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.
A study testing Accu-Chek FlexLink and Accu-Chek FlexLink Plus in people with Diabetes Mellitus Type 2, Diabetes Mellitus Type 1, run by Hoffmann-La Roche at 5 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetes Mellitus Type 2, Diabetes Mellitus Type 1
- What is being tested?
- Accu-Chek FlexLink and Accu-Chek FlexLink Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesGermany
- Study dates
- 1 Nov 2013to 30 Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Study site
Aschaffenburg, 63739
Study site
Berlin, 01627
Study site
Berlin, 13597
Study site
Rostock, 18057
Study site
Ulm, 89081
About this study
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.
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.
- Being tested
- Accu-Chek FlexLink, Accu-Chek FlexLink Plus
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accu-Chek FlexLinkDevice
Insulin pump device used for 4-weeks under real life conditions
Accu-Chek FlexLink PlusDevice
Insulin pump device used for 4-weeks under real life conditions
| Study group | Role | What they receive |
|---|---|---|
| Accu-Chek FlexLink Plus cross over to Accu-Chek FlexLink | Other | Not described Receives: Device: Accu-Chek FlexLink; Device: Accu-Chek FlexLink Plus |
| Accu-Chek FlexLink cross over to Accu-Chek FlexLink Plus | Other | Not described Receives: Device: Accu-Chek FlexLink; Device: Accu-Chek FlexLink Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of pain during infusion set insertion assessed by means of a visual analogue scale (VAS)
Measured: 8 weeks
Secondary outcomes (6)
Incidence of kinked cannulas
Measured: 8 weeks
Pump settings, including insulin dosage
Measured: 8 weeks
Device satisfaction/preference as assessed by patient surveys
Measured: 8 weeks
Investigator assessment of patient device use
Measured: At Baseline and Week 4
Incidence of adverse events
Measured: 8 weeks
Insulin set replacement pattern
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study start1 Nov 2013
- Primary completion30 Jun 2014
- Study completion30 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2, Diabetes Mellitus Type 1Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Linda Amstutz, Study director, Roche Diagnostics GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103595
- Sponsor's protocol ID
- RD001494
- Status last verified
- Apr 2017
- First submitted
- 29 Jan 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02103595
- Acronym / sponsor ID
- RD001494
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 30 Jun 2014 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accu-Chek FlexLink Plus cross over to Accu-Chek FlexLink | Other | Device: Accu-Chek FlexLink, Device: Accu-Chek FlexLink Plus |
| Accu-Chek FlexLink cross over to Accu-Chek FlexLink Plus | Other | Device: Accu-Chek FlexLink, Device: Accu-Chek FlexLink Plus |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accu-Chek FlexLinkInsulin pump device used for 4-weeks under real life conditions | Device | Accu-Chek FlexLink Plus cross over to Accu-Chek FlexLink, Accu-Chek FlexLink cross over to Accu-Chek FlexLink Plus |
| Accu-Chek FlexLink PlusInsulin pump device used for 4-weeks under real life conditions | Device | Accu-Chek FlexLink Plus cross over to Accu-Chek FlexLink, Accu-Chek FlexLink cross over to Accu-Chek FlexLink Plus |
Primary outcome
Perception of pain during infusion set insertion assessed by means of a visual analogue scale (VAS)
Time frame: 8 weeks
6 secondary outcomes
Incidence of kinked cannulas
Time frame: 8 weeks
Pump settings, including insulin dosage
Time frame: 8 weeks
Device satisfaction/preference as assessed by patient surveys
Time frame: 8 weeks
Investigator assessment of patient device use
Time frame: At Baseline and Week 4
Incidence of adverse events
Time frame: 8 weeks
Insulin set replacement pattern
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Amstutz study director
Roche Diagnostics GmbH
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accu-Chek FlexLink and Accu-Chek FlexLink Plus in people with Diabetes Mellitus Type 2, Diabetes Mellitus Type 1, run by Hoffmann-La Roche at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of pain during infusion set insertion assessed by means of a visual analogue scale (VAS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.