Type 1 DiabetesNCT00970567
Ketoacidosis in Individuals With Type I Diabetes Mellitus (T1DM)
A study testing Different insulin therapy at different time points in people with Type 1 Diabetes, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to investigate individuals with type 1 diabetes who were disconnected from their insulin pump and insulin therapy was started again after positive ketones (U) in the urine or blood β-hydroxybutyrate. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Different insulin therapy at different time points
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- type 1 diabetes
Who cannot join
- severe hypo- or hyperglycemia during last 6 months
- acute illness
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité-Universitätsmedizin Berlin, Department of Endocrinology, Diabetes and Nutrition
Berlin, State of Berlin, 12200
About this study
Official title: Ketoacidosis in Individuals With T1DM
The purpose of this study is to investigate individuals with type 1 diabetes who were disconnected from their insulin pump and insulin therapy was started again after positive ketones (U) in the urine or blood β-hydroxybutyrate.
Read the detailed description
Individuals with type 1 diabetes were disconnected from their insulin pump and insulin therapy was started again after positive ketones (U) in the urine or blood β-hydroxybutyrate with different therapy regimens after positive blood ketones.
- Conditions
- Type 1 Diabetes
- Being tested
- Different insulin therapy at different time points
- Keywords
- therapy after positive ketone bodies in the blood, timepoint of diagnosis, timepoint of metabolic normalisation
- 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.
Different insulin therapy at different time pointsBehavioural
different insulin therapy after positive blood ketones
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | stop after positive ketone bodies in urine Receives: Behavioral: Different insulin therapy at different time points |
| Arm 2 | Other | stop after positive ketone bodies in blood, normal therapy Receives: Behavioral: Different insulin therapy at different time points |
| Arm 3 | Other | stop after positive ketone bodies in blood, additional therapy Receives: Behavioral: Different insulin therapy at different time points |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose metabolism, time course of positive ketone bodies
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Investigators
- Joachim Spranger, MD, Study director, Charité, CBF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970567
- Sponsor's protocol ID
- EA4/039/07
- Status last verified
- Sep 2009
- First submitted
- 5 Aug 2009
- Last updated
- 2 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketoacidosis in Individuals With T1DM
- ClinicalTrials.gov ID
- NCT00970567
- Acronym / sponsor ID
- EA4/039/07
- Conditions
- Type 1 Diabetes
- Keywords
- therapy after positive ketone bodies in the blood, timepoint of diagnosis, timepoint of metabolic normalisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 2 Sep 2009 (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.
The purpose of this study is to investigate individuals with type 1 diabetes who were disconnected from their insulin pump and insulin therapy was started again after positive ketones (U) in the urine or blood β-hydroxybutyrate.
Detailed description
Individuals with type 1 diabetes were disconnected from their insulin pump and insulin therapy was started again after positive ketones (U) in the urine or blood β-hydroxybutyrate with different therapy regimens after positive blood ketones.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Different insulin therapy at different time pointsstop after positive ketone bodies in urine |
| Arm 2 | Other | Behavioral: Different insulin therapy at different time pointsstop after positive ketone bodies in blood, normal therapy |
| Arm 3 | Other | Behavioral: Different insulin therapy at different time pointsstop after positive ketone bodies in blood, additional therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- type 1 diabetes
Key exclusion criteria (2 listed)
- severe hypo- or hyperglycemia during last 6 months
- acute illness
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 |
|---|---|---|
| Different insulin therapy at different time pointsdifferent insulin therapy after positive blood ketones | Behavioural | Arm 1, Arm 2, Arm 3 |
Primary outcome
glucose metabolism, time course of positive ketone bodies
Time frame: 6 hours
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 2 Sep 2009.
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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.
Joachim Spranger, MD study director
Charité, CBF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different insulin therapy at different time points in people with Type 1 Diabetes, run by Charite University, Berlin, Germany 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 1 inclusion and 2 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 2 Sep 2009. 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?
glucose metabolism, time course of positive ketone bodies (time frame: 6 hours). 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 2 Sep 2009.