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

  • Germany
      • 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
Behavioral: Different insulin therapy at different time points
different insulin therapy after positive blood ketones
Other: 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
Other: 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

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.

Sponsor

Charite University, Berlin, Germany

Collaborators

Abbott

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.

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