Ketoacidosis in Individuals With Type I Diabetes Mellitus (T1DM)
September 1, 2009 updated by: Charite University, Berlin, Germany
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, 12200
- Charité-Universitätsmedizin Berlin, Department of Endocrinology, Diabetes and Nutrition
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- type 1 diabetes
Exclusion Criteria:
- severe hypo- or hyperglycemia during last 6 months
- acute illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Arm 1
stop after positive ketone bodies in urine
|
different insulin therapy after positive blood ketones
|
|
Other: Arm 2
stop after positive ketone bodies in blood, normal therapy
|
different insulin therapy after positive blood ketones
|
|
Other: Arm 3
stop after positive ketone bodies in blood, additional therapy
|
different insulin therapy after positive blood ketones
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
glucose metabolism, time course of positive ketone bodies
Time Frame: 6 hours
|
6 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Joachim Spranger, MD, Charité, CBF
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
August 5, 2009
First Submitted That Met QC Criteria
September 1, 2009
First Posted (Estimate)
September 2, 2009
Study Record Updates
Last Update Posted (Estimate)
September 2, 2009
Last Update Submitted That Met QC Criteria
September 1, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA4/039/07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.