Ketoacidosis in Individuals With Type I Diabetes Mellitus (T1DM)

NCT ID: NCT00970567

Last Updated: 2009-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Arm 1

stop after positive ketone bodies in urine

Group Type OTHER

Different insulin therapy at different time points

Intervention Type BEHAVIORAL

different insulin therapy after positive blood ketones

Arm 2

stop after positive ketone bodies in blood, normal therapy

Group Type OTHER

Different insulin therapy at different time points

Intervention Type BEHAVIORAL

different insulin therapy after positive blood ketones

Arm 3

stop after positive ketone bodies in blood, additional therapy

Group Type OTHER

Different insulin therapy at different time points

Intervention Type BEHAVIORAL

different insulin therapy after positive blood ketones

Interventions

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Different insulin therapy at different time points

different insulin therapy after positive blood ketones

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* type 1 diabetes

Exclusion Criteria

* severe hypo- or hyperglycemia during last 6 months
* acute illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Charité-Universitätsmedizin Berlin, Department of Endocrinology, Diabetes and Nutrition

Principal Investigators

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Joachim Spranger, MD

Role: STUDY_DIRECTOR

Charité, CBF

Locations

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Charité-Universitätsmedizin Berlin, Department of Endocrinology, Diabetes and Nutrition

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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EA4/039/07

Identifier Type: -

Identifier Source: org_study_id

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