Diabetes Mellitus Type 1NCT00569452
Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate
A study testing Accu-Chek Spirit Insulin Pump in people with Diabetes Mellitus Type 1, run by Hoffmann-La Roche at 1 site in Germany.
Trial summary
This is a pilot trial to establish study procedures that allow comparison of various starting basal rate profiles used in Continuous Subcutaneous Insulin Infusion (CSII). Glycemic control achieved by circadian 'slide ruler scale' basal rate versus that achieved by one constant basal rate (flat profile) will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 1
- What is being tested?
- Accu-Chek Spirit Insulin Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to May 2006
- 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
- Adult, Older adult
Who may be able to join
- Adult patients >= 18 years of age
- Type 1 diabetes
- Diabetic for >2 years, and treated with CSII for >= 3 months
- HbA1c <=8.5%
Who cannot join
- Excessive fibrosis or lipo-hypertrophy at injection or infusion sites
- Unstable chronic disease other than type 1 diabetes
- Severe hypoglycemic event within last week prior to study start
- Severe diabetic ketoacidosis within last month prior to study start
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot trial to establish study procedures that allow comparison of various starting basal rate profiles used in Continuous Subcutaneous Insulin Infusion (CSII). Glycemic control achieved by circadian 'slide ruler scale' basal rate versus that achieved by one constant basal rate (flat profile) will be compared during a composite fasting day as well as therapeutic success after 2 weeks of normal activity.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- Accu-Chek Spirit 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
One basal rate
Accu-Chek Spirit Insulin PumpDevice
Multiple basal rates
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: Accu-Chek Spirit Insulin Pump |
| B | Experimental | Not described Receives: Device: Accu-Chek Spirit Insulin Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot trial to establish endpoints such as "time within target range of a composite fasting day"
Measured: Study duration
Secondary outcomes (1)
AUC, MAGE, HbA1c, body weight change
Measured: Study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startJan 2006
- Primary completionMay 2006
- Study completionMay 2006
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Buhr, Study director, Disetronic Medical Systems AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569452
- Sponsor's protocol ID
- RD000278
- Other IDs
- DMS-01-CIRCADIAN-01
- Status last verified
- Jun 2010
- First submitted
- 6 Dec 2007
- 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
- Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate
- ClinicalTrials.gov ID
- NCT00569452
- Acronym / sponsor ID
- RD000278
- Conditions
- Diabetes Mellitus Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 7 Dec 2007 (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 is a pilot trial to establish study procedures that allow comparison of various starting basal rate profiles used in Continuous Subcutaneous Insulin Infusion (CSII). Glycemic control achieved by circadian 'slide ruler scale' basal rate versus that achieved by one constant basal rate (flat profile) will be compared during a composite fasting day as well as therapeutic success after 2 weeks of normal activity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Accu-Chek Spirit Insulin Pump |
| B | Experimental | Device: Accu-Chek Spirit Insulin Pump |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients >= 18 years of age
- Type 1 diabetes
- Diabetic for >2 years, and treated with CSII for >= 3 months
- HbA1c <=8.5%
Key exclusion criteria (4 listed)
- Excessive fibrosis or lipo-hypertrophy at injection or infusion sites
- Unstable chronic disease other than type 1 diabetes
- Severe hypoglycemic event within last week prior to study start
- Severe diabetic ketoacidosis within last month prior to study start
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 PumpOne basal rate | Device | A |
| Accu-Chek Spirit Insulin PumpMultiple basal rates | Device | B |
Primary outcome
Pilot trial to establish endpoints such as "time within target range of a composite fasting day"
Time frame: Study duration
1 secondary outcome
AUC, MAGE, HbA1c, body weight change
Time frame: Study duration
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.
Andreas Buhr study director
Disetronic Medical Systems AG
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 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 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 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?
Pilot trial to establish endpoints such as "time within target range of a composite fasting day" (time frame: Study duration). 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.