Diabetes Mellitus Clinical Trial
Official title:
Evaluation of a Newly Developed Treatment and Education Program (INPUT) for Diabetic Patients Performing an Insulin Pump Therapy
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.
INPUT is a self-management-based treatment and education program for diabetic patients with
an insulin pump (CSII). It is designed to empower patients to adequately perform their
therapy in daily life and to integrate their diabetes and their insulin pump into their lifes
in order to enhance quality of life.
INPUT ist tested in an randomized controlled trial (RCT) with a waiting-list control group
since no certified and effective treatment and education program for CSII exists.
This study is a multi-center study. Study centers are specialized diabetes practices
throughout Germany. Patients will be approached by their respective practice and informed
about the study. Study measurements as well as the conduct of INPUT will take place at the
respective practice.
Baseline measurement will take place 2 weeks prior to the beginning of INPUT. After
completion of baseline measurement, all patients from one study center will be randomized
centrally by the Research Institute of the Diabetes Academy Mergentheim (FIDAM). 2 weeks and
6 months after the completion of INPUT, follow-up measurements will be conducted at the
respective study center.
HbA1c as a marker of glycemic control will be analyzed in a central laboratory. Secondary
outcome measures will be assessed via psychometrically tested questionnaires, Case Reports
Forms, or patient files.
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