Type 2 Diabetes, Type 1 DiabetesNCT02105103
European, Open-label, Prospective, Multinational, Multicenter Study in Adult Subjects With Type 1 or Type 2 Diabetes Previously on MDI or CSII Therapy. Subjects Home Setting is Considered Routine Practice.
A study testing Accu-Chek® Insight Insulin Pump in people with Type 2 Diabetes, Type 1 Diabetes, run by Hoffmann-La Roche at 8 sites in 2 countries.
Trial summary
Accu-Chek® Insight Insulin Pump EU Study is a Multicenter Study to evaluate the Accu-Chek® Insight Insulin Pump in routine practice. This is an open-label, prospective, multinational, multicenter study evaluating the CSII therapy with the Accu-Chek Insight Insulin pump in routine practice in adult subjects with Type 1… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Type 1 Diabetes
- What is being tested?
- Accu-Chek® Insight Insulin Pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Oct 2013to Mar 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years old
- Diagnosed at least for 12 months with Type 1 or 2 Diabetes requiring insulin therapy
- Intensive insulin therapy by MDI or CSII at least 6 months
- Willing to self monitor blood glucose 4 times daily
Who cannot join
- Significantly impaired awareness of hypoglycemia
- Unstable chronic disease other than diabetes
- Acute illness or inability to recognize pump signals or alarms as determined by the investigator
- Pregnancy
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United Kingdom6 sites
Study site
Birmingham, B15 2WB
Study site
Birmingham, B9 SSS
Study site
Blackburn, BB23HH
Study site
Leicester, LE15WW
Study site
Middlesbrough, TS4 3BW
Study site
Stafford, ST16 2ST
About this study
Official title: Accu-Chek® Insight Insulin Pump EU Study: A European Multicenter Study to Evaluate the Accu-Chek® Insight Insulin Pump in Routine Practice
Accu-Chek® Insight Insulin Pump EU Study is a Multicenter Study to evaluate the Accu-Chek® Insight Insulin Pump in routine practice. This is an open-label, prospective, multinational, multicenter study evaluating the CSII therapy with the Accu-Chek Insight Insulin pump in routine practice in adult subjects with Type 1 or type 2 diabetes. Subjects must have been on intensive insulin therapy for at least six months i.e. either on CSII or MDI. All subjects will receive training in the preparation, programming and daily use of the Accu-Chek Insight Insulin pump. In addition, subjects previously on MDI may receive more training in order to be comfortable with the use of an insulin pump. The study will be conducted in 10-12 sites in Austria, France and the United Kingdom. A total of 80-95 subjects will be enrolled in this study.
- Conditions
- Type 2 Diabetes, Type 1 Diabetes
- Being tested
- Accu-Chek® Insight Insulin Pump
- 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® Insight Insulin PumpDevice
A new insulin pump, the Accu-Chek® Insight insulin pump, will be used by all subjects enrolled in this study. The usability of the Accu-Chek® Insight insulin pump for the intended use has already been investigated in a Human Factor study. The study subjects may encounter the following potential risks of CSII therapy while participating in the study: Possible hypoglycemia; Possible hyperglycemia which might progress to ketosis and DKA; Infusion site reactions (bleeding, bruising, discomfort, pruritus, pain, plaster reactions, inflammation, infection etc.)
| Study group | Role | What they receive |
|---|---|---|
| Accu-Chek® Insight Insulin Pump | Other | Not described Receives: Device: Accu-Chek® Insight Insulin Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate the Accu-Chek Insight Insulin Pump and associated pump devices in routine practice. This will be expressed by the rate of error messages per 100 patient years (confirmed by pump uploads).
Measured: 6 months
Secondary outcomes (6)
Evaluate type and frequency of adverse events (serious/non-serious) possibly related or related to study devices and/or study procedures
Measured: 6 months
Evaluate subject satisfaction based on surveys of important factors of health-related quality of life
Measured: 6 months
Evaluate change in HbA1c from screening to month 3 and 6
Measured: 3 weeks screening plus 6 months treatment period
Evaluate utilization of pump functions (e.g. basal rate profiles, temporary basal rates, bolus types)
Measured: 6 months
Evaluate change in CGM-derived parameters from month 3 to month 6
Measured: 6 months
Evaluate type and frequency of pump signals, i.e. reminders, errors, warnings, alarms, maintenance messages
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes, Type 1 DiabetesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bettina Petersen, Study director, Roche Diagnostics GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105103
- Sponsor's protocol ID
- RD001514
- Status last verified
- Sep 2016
- First submitted
- 28 Mar 2014
- Last updated
- 9 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accu-Chek® Insight Insulin Pump EU Study: A European Multicenter Study to Evaluate the Accu-Chek® Insight Insulin Pump in Routine Practice
- ClinicalTrials.gov ID
- NCT02105103
- Acronym / sponsor ID
- RD001514
- Conditions
- Type 2 Diabetes, Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 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.
Accu-Chek® Insight Insulin Pump EU Study is a Multicenter Study to evaluate the Accu-Chek® Insight Insulin Pump in routine practice. This is an open-label, prospective, multinational, multicenter study evaluating the CSII therapy with the Accu-Chek Insight Insulin pump in routine practice in adult subjects with Type 1 or type 2 diabetes. Subjects must have been on intensive insulin therapy for at least six months i.e. either on CSII or MDI. All subjects will receive training in the preparation, programming and daily use of the Accu-Chek Insight Insulin pump. In addition, subjects previously on MDI may receive more training in order to be comfortable with the use of an insulin pump. The study will be conducted in 10-12 sites in Austria, France and the United Kingdom. A total of 80-95 subjects will be enrolled in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accu-Chek® Insight Insulin Pump | Other | Device: Accu-Chek® Insight Insulin Pump |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female at least 18 years old
- Diagnosed at least for 12 months with Type 1 or 2 Diabetes requiring insulin therapy
- Intensive insulin therapy by MDI or CSII at least 6 months
- Willing to self monitor blood glucose 4 times daily
Key exclusion criteria (4 listed)
- Significantly impaired awareness of hypoglycemia
- Unstable chronic disease other than diabetes
- Acute illness or inability to recognize pump signals or alarms as determined by the investigator
- Pregnancy
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® Insight Insulin PumpA new insulin pump, the Accu-Chek® Insight insulin pump, will be used by all subjects enrolled in this study. The usability of the Accu-Chek® Insight insulin pump for the intended use has already been investigated in a Human Factor study. The study subjects may encounter the following potential risks of CSII therapy while participating in the study: Possible hypoglycemia; Possible hyperglycemia which might progress to ketosis and DKA; Infusion site reactions (bleeding, bruising, discomfort, pruritus, pain, plaster reactions, inflammation, infection etc.) | Device | Accu-Chek® Insight Insulin Pump |
Primary outcome
The primary objective is to evaluate the Accu-Chek Insight Insulin Pump and associated pump devices in routine practice. This will be expressed by the rate of error messages per 100 patient years (confirmed by pump uploads).
Time frame: 6 months
6 secondary outcomes
Evaluate type and frequency of adverse events (serious/non-serious) possibly related or related to study devices and/or study procedures
Time frame: 6 months
Evaluate subject satisfaction based on surveys of important factors of health-related quality of life
Time frame: 6 months
Evaluate change in HbA1c from screening to month 3 and 6
Time frame: 3 weeks screening plus 6 months treatment period
Evaluate utilization of pump functions (e.g. basal rate profiles, temporary basal rates, bolus types)
Time frame: 6 months
Evaluate change in CGM-derived parameters from month 3 to month 6
Time frame: 6 months
Evaluate type and frequency of pump signals, i.e. reminders, errors, warnings, alarms, maintenance messages
Time frame: 6 months
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 9 Sep 2016.
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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.
Bettina Petersen study director
Roche Diagnostics GmbH
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accu-Chek® Insight Insulin Pump in people with Type 2 Diabetes, Type 1 Diabetes, run by Hoffmann-La Roche at 8 sites in 2 countries.
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 4 inclusion and 4 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 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Austria. 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?
The primary objective is to evaluate the Accu-Chek Insight Insulin Pump and associated pump devices in routine practice. This will be expressed by the rate of error messages per 100 patient years (confirmed by pump uploads). (time frame: 6 months). 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 9 Sep 2016.