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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 19, 2014