Ketoacidosis in Individuals With Type I Diabetes Mellitus (T1DM)

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: Different insulin therapy at different time points

• Registration Number: NCT00970567
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

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 Timeline

• Study Start: 2007-11
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2009-08-05
• Status Verified: 2009-09
• Study First Submitted QC: 2009-09-01
• Last Update Submitted: 2009-09-01
• Study First Posted: 2009-09-02
• Last Update Posted: 2009-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• type 1 diabetes

Exclusion Criteria

• severe hypo- or hyperglycemia during last 6 months
• acute illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Different insulin therapy at different time points	stop after positive ketone bodies in urine
Arm 2	Different insulin therapy at different time points	stop after positive ketone bodies in blood, normal therapy
Arm 3	Different insulin therapy at different time points	stop after positive ketone bodies in blood, additional therapy

Primary Outcome Measures

Name	Time	Method
glucose metabolism, time course of positive ketone bodies	6 hours

Trial Locations

Locations (1)

Charité-Universitätsmedizin Berlin, Department of Endocrinology, Diabetes and Nutrition; 🇩🇪 Berlin, Germany