NCT00444483

Brief Summary

The improvement of the quality of life (QoL) is one of the key treatment goals in patients with diabetes mellitus. Objective: Prospective study to evaluate the impact of structured diabetes education on the QoL in insulin-treated, elderly patients with type 2 diabetes mellitus. Inpatients with insulin treated type 2 diabetes or failure of oral antidiabetic therapy were successively recruited and participated in the structured inpatient diabetes treatment and teaching program (DTTP) for insulin therapy QoL was assessed before and six months after participation in the DTTP with the standardised questionnaire of Lohr analysing the subscales: social relations, physical complaints, worries about the future, diet restrictions, fear of hypoglycemia, and daily struggles.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2007

Completed
Last Updated

March 7, 2007

Status Verified

March 1, 2007

First QC Date

March 6, 2007

Last Update Submit

March 6, 2007

Conditions

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure regarding patients metabolic control was the improvement of quality of life six months after DTTP.

Secondary Outcomes (1)

  • A secondary objective of the study was the comparison of QoL- subscale in patients already on insulin therapy with those newly on insulin therapy.

Interventions

Eligibility Criteria

Age54 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabetes mellitus, insulin therapy, age \>54 years, hyperglycemia

You may not qualify if:

  • dementia, severe neurological deficits, polioencephalitis, rejection of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ulrich Müller, MD

    University of Jena

    PRINCIPAL INVESTIGATOR
  • Anke Braun, MD

    Bethanien Hospital Heidelberg, Germany

    STUDY CHAIR
  • Ralf Schiel, MD

    Inselklinik Heringsdorf, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2007

First Posted

March 7, 2007

Last Updated

March 7, 2007

Record last verified: 2007-03