NCT00970567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
Last Updated

September 2, 2009

Status Verified

September 1, 2009

Enrollment Period

1.1 years

First QC Date

August 5, 2009

Last Update Submit

September 1, 2009

Conditions

Type 1 Diabetes

Keywords

therapy after positive ketone bodies in the bloodtimepoint of diagnosistimepoint of metabolic normalisation

Outcome Measures

Primary Outcomes (1)

  • glucose metabolism, time course of positive ketone bodies

    6 hours

Study Arms (3)

Arm 1

OTHER

stop after positive ketone bodies in urine

Behavioral: Different insulin therapy at different time points

Arm 2

OTHER

stop after positive ketone bodies in blood, normal therapy

Behavioral: Different insulin therapy at different time points

Arm 3

OTHER

stop after positive ketone bodies in blood, additional therapy

Behavioral: Different insulin therapy at different time points

Interventions

Different insulin therapy at different time pointsBEHAVIORAL

different insulin therapy after positive blood ketones

Arm 1Arm 2Arm 3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • type 1 diabetes

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Berlin, State of Berlin, 12200, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Joachim Spranger, MD

    Charité, CBF

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2009

First Posted

September 2, 2009

Study Start

November 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

September 2, 2009

Record last verified: 2009-09

Locations

DE(1)