Status:

COMPLETED

Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)

Lead Sponsor:

Forschungsinstitut der Diabetes Akademie Mergentheim

Conditions:

Type 1 Diabetes

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

This study is a randomized prospective trial with 6-month follow up. A non-inferiority hypothesis is tested. A new developed treatment and education programme for type 1 diabetic patients (PRIMAS) wil...

Detailed Description

Both programmes consists of 12 lessons with a length of 90 minutes. Eligible type 1 diabetic patients in a diabetologist practice are pooled and randomised either to the new developed PRIMAS programme...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • type 1 diabetes, diabetes duration \> 4 weeks, age 18 - 75 years, BMI 20 - 40 kg/m², A1c 7 - 13 %, ability to understand, speak and write German language, written informed consent.
  • Exclusion criteria:
  • current treatment of psychological or psychiatric disorder, dementia or severe cognitive impairment, severe organic disease (e.g. terminal renal disease, cancer with poor prognosis), preventing a regular participation in the training course, pregnancy.

Exclusion

    Key Trial Info

    Start Date :

    September 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2012

    Estimated Enrollment :

    160 Patients enrolled

    Trial Details

    Trial ID

    NCT01220557

    Start Date

    September 1 2010

    End Date

    March 1 2012

    Last Update

    August 17 2021

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