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Ketoacidosis in Individuals With Type I Diabetes Mellitus (T1DM)

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00970567
First received: August 5, 2009
Last updated: September 1, 2009
Last verified: September 2009
History of Changes
  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: Open Label
Official Title: Ketoacidosis in Individuals With T1DM

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: August 5, 2009
Last Updated: September 1, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Diabetes Mellitus, Type 1
Ketosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Acidosis
Acid-Base Imbalance
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013