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NCT00970567 Clinical Trial

Ketoacidosis in Individuals With Type I Diabetes Mellitus (T1DM)

Type 1 Diabetes Clinical Trial

Official title:
Ketoacidosis in Individuals With T1DM

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00970567
Other study ID # EA4/039/07
Secondary ID
Status Completed
Phase N/A
First received August 5, 2009
Last updated September 1, 2009
Start date November 2007
Est. completion date December 2008

Study information
Verified date September 2009
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- type 1 diabetes

Exclusion Criteria:

- severe hypo- or hyperglycemia during last 6 months

- acute illness

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany Charité-Universitätsmedizin Berlin, Department of Endocrinology, Diabetes and Nutrition Berlin

Sponsors (2)
Lead Sponsor Collaborator
Charite University, Berlin, Germany Abbott

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary glucose metabolism, time course of positive ketone bodies 6 hours No
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