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Ketoacidosis in Individuals With Type I Diabetes Mellitus (T1DM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00970567
First Posted: September 2, 2009
Last Update Posted: September 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by:
Charite University, Berlin, Germany
  Purpose
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.

Condition Intervention
Type 1 Diabetes Behavioral: Different insulin therapy at different time points

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Ketoacidosis in Individuals With T1DM

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • glucose metabolism, time course of positive ketone bodies [ Time Frame: 6 hours ]

Enrollment: 19
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
stop after positive ketone bodies in urine
Behavioral: Different insulin therapy at different time points
different insulin therapy after positive blood ketones
Arm 2
stop after positive ketone bodies in blood, normal therapy
Behavioral: Different insulin therapy at different time points
different insulin therapy after positive blood ketones
Arm 3
stop after positive ketone bodies in blood, additional therapy
Behavioral: Different insulin therapy at different time points
different insulin therapy after positive blood ketones

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 1 diabetes

Exclusion Criteria:

  • severe hypo- or hyperglycemia during last 6 months
  • acute illness
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970567


Locations
Germany
Charité-Universitätsmedizin Berlin, Department of Endocrinology, Diabetes and Nutrition
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
Abbott
Investigators
Study Director: Joachim Spranger, MD Charité, CBF
  More Information

Additional Information:
Responsible Party: Professor J. Spranger, Charité-Universitätsmedizin Berlin, Department of Endocrinology, Diabetes and Nutrition
ClinicalTrials.gov Identifier: NCT00970567     History of Changes
Other Study ID Numbers: EA4/039/07
First Submitted: August 5, 2009
First Posted: September 2, 2009
Last Update Posted: September 2, 2009
Last Verified: September 2009

Keywords provided by Charite University, Berlin, Germany:
therapy after positive ketone bodies in the blood
timepoint of diagnosis
timepoint of metabolic normalisation

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Ketosis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Acidosis
Acid-Base Imbalance
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs