Diabetes Mellitus Type 1NCT00772356
A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes
A study testing Accu-Chek Spirit Insulin Pump and Comparator insulin pump in people with Diabetes Mellitus Type 1, run by Hoffmann-La Roche at 1 site in Germany.
Trial summary
This crossover, glucose-clamp study will investigate the impact of different basal insulin infusion rates on glucose control employing insulin pumps with different insulin delivery regimen. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Diabetes Mellitus Type 1
- What is being tested?
- Accu-Chek Spirit Insulin Pump and Comparator insulin pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to May 2008
- 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 65 years
- Men only
- Adult, Older adult
Who may be able to join
- Male patients 18-65 years of age
- Type I diabetes mellitus
- Currently on continuous subcutaneous insulin infusion therapy
Who cannot join
- Proliferative retinopathy or maculopathy requiring actue treatment within last 6 months
- Use of systemic corticoids in last 3 months
- Treatment with medication known to interfere with glucose metabolism
Trial locations and contacts
1 site in 1 country.
About this study
This crossover, glucose-clamp study will investigate the impact of different basal insulin infusion rates on glucose control employing insulin pumps with different insulin delivery regimen. Patients will be randomized in one of 2 groups, to receive on the first study day insulin via pumps with pulsatile or quasi-continuous delivery modes. On the second study day they will be switched to treatment with the alternative delivery regimen. The anticipated duration of the trial is 2 study days and the target sample size is 14 individuals.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- Accu-Chek Spirit Insulin Pump, Comparator insulin pump
- Medical subject headings
- 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 Spirit Insulin PumpDevice
Comparator insulin pumpDevice
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: Accu-Chek Spirit Insulin Pump |
| B | Active comparator | Not described Receives: Device: Comparator insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of glucose infusion rate necessary to keep blood glucose constant
Measured: Throughout study
Secondary outcomes (1)
Serum insulin and free fatty acid levels
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bettina Dr. Petersen, Study director, Roche Diagnostics GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772356
- Sponsor's protocol ID
- RD000559
- Other IDs
- 05/0377-Basal
- Status last verified
- Jun 2010
- First submitted
- 13 Oct 2008
- Last updated
- 3 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes
- ClinicalTrials.gov ID
- NCT00772356
- Acronym / sponsor ID
- RD000559
- Conditions
- Diabetes Mellitus Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 15 Oct 2008 (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.
This crossover, glucose-clamp study will investigate the impact of different basal insulin infusion rates on glucose control employing insulin pumps with different insulin delivery regimen. Patients will be randomized in one of 2 groups, to receive on the first study day insulin via pumps with pulsatile or quasi-continuous delivery modes. On the second study day they will be switched to treatment with the alternative delivery regimen. The anticipated duration of the trial is 2 study days and the target sample size is 14 individuals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Accu-Chek Spirit Insulin Pump |
| B | Active comparator | Device: Comparator insulin pump |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male patients 18-65 years of age
- Type I diabetes mellitus
- Currently on continuous subcutaneous insulin infusion therapy
Key exclusion criteria (3 listed)
- Proliferative retinopathy or maculopathy requiring actue treatment within last 6 months
- Use of systemic corticoids in last 3 months
- Treatment with medication known to interfere with glucose metabolism
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 Spirit Insulin Pump | Device | A |
| Comparator insulin pump | Device | B |
Primary outcome
Comparison of glucose infusion rate necessary to keep blood glucose constant
Time frame: Throughout study
1 secondary outcome
Serum insulin and free fatty acid levels
Time frame: Throughout study
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 3 Mar 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 Dr. Petersen study director
Roche Diagnostics GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accu-Chek Spirit Insulin Pump and Comparator insulin pump in people with Diabetes Mellitus Type 1, run by Hoffmann-La Roche at 1 site 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 3 inclusion and 3 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 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Comparison of glucose infusion rate necessary to keep blood glucose constant (time frame: Throughout study). 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 3 Mar 2016.