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Evaluation of a Diabetes Treatment and Education Program for Insulin Pump Therapy (INPUT)

NCT02868931 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2017-11-28

No results posted yet for this study

Summary

This study is a randomized, controlled, prospective trial with a 6-month follow-up. A newly developed treatment and education programme for diabetic patients with an insulin pump therapy (INPUT) will be tested compared to a waiting group. Primary outcome variable is the difference in glycemic control between baseline and the 6-month follow-up. Secondary outcome variables are: severe hypoglycaemia, diabetes-related distress, depressive symptoms, health-related quality of life, diabetes empowerment, self-care behavior, hypoglycemia awareness, and attitudes towards insulin pump therapy.

Conditions

Interventions

BEHAVIORAL

INPUT

Treatment and education program based on the self-management theory of behavioral medicine. The program is delivered by certified and specially trained diabetes educators.

Sponsors & Collaborators

  • Berlin-Chemie

    collaborator UNKNOWN

  • Norbert Hermanns

    lead OTHER

Principal Investigators

  • Norbert Hermanns, PhD · Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2017-02-28
Completion
2017-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02868931 on ClinicalTrials.gov