NCT00391040

Brief Summary

It was the aim of the study to develop and evaluate the effectiveness of a new structured teaching and training programme for elderly patients with diabetes mellitus (SGS) and insulin therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2003

Typical duration for not_applicable diabetes-mellitus

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, 2003

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2006

Completed
Last Updated

October 23, 2006

Status Verified

October 1, 2006

First QC Date

October 20, 2006

Last Update Submit

October 20, 2006

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus, structured treatment and teaching, education,elderly patients, geriatrics

Outcome Measures

Primary Outcomes (1)

  • HbA1c decrease, reduction of hypoglycemia, acute complications

Secondary Outcomes (1)

  • treatment satisfaction, ability for diabetes management, diabetes knowledge

Interventions

SGS educationBEHAVIORAL

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age older than 65 years, at least more than one other diagnosis than diabetes, at least one geriatric syndrome

You may not qualify if:

  • myocardial infarction, apoplexy within the last 2 weeks before planned enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bethesda Hospital

Stuttgart, Baden-Wurttemberg, 70184, Germany

Location

Related Publications (2)

  • Zeyfang A. [Diabetes in old age -- do we overstrain our patients?]. Dtsch Med Wochenschr. 2006 May 19;131(20):1159-62. doi: 10.1055/s-2006-941744. No abstract available. German.

    PMID: 16705538BACKGROUND

  • Zeyfang A. [Structured educational programs for geriatric patients with diabetes mellitus]. MMW Fortschr Med. 2005 Jun 30;147(26):43, 45-6. German.

    PMID: 16035489RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Andrej Zeyfang, MD

    German Diabetes Association- Working Group Diabetes and Geriatrics

    PRINCIPAL INVESTIGATOR

  • Anke Braun, MD

    German Diabetes Association- Working Group Diabetes and Geriatrics

    STUDY CHAIR

  • Thomas Kubiak, MD

    German Diabetes Association- Working Group Diabetes and Geriatrics

    STUDY CHAIR

  • Ulrich A Müller, Prof

    University of Jena

    STUDY CHAIR

  • Jörn Kuntsche, MD

    German Diabetes Association- Working Group Diabetes and Geriatrics

    STUDY CHAIR

  • Martina Meier-Höfig, MD

    German Diabetes Association- Working Group Diabetes and Geriatrics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2006

First Posted

October 23, 2006

Study Start

November 1, 2003

Study Completion

May 1, 2006

Last Updated

October 23, 2006

Record last verified: 2006-10

Locations

DE(1)