Evaluation of a Diabetes Treatment and Education Program for Insulin Pump Therapy (INPUT)
NCT ID: NCT02868931
Last Updated: 2017-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
268 participants
INTERVENTIONAL
2016-04-01
2017-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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INPUT
INPUT consists of 12 lessons comprising all relevant information in order to treat diabetes with an insulin pump. Patients learn to effectively use the different features of their pump in order to improve not only glycemic control but also to improve the implementation of pump therapy in daily life. Psychological and motivational aspects of living with diabetes and living with an insulin pump are addressed as well.
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.
Waiting list
Patients are randomly assigned to the waiting list. After completion of the 6-month follow-up, these patients will also receive training with INPUT.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior participation in a structured diabetes education program
* HbA1c ≥ 7,5% but ≤ 13%
* Ability to understand, speak and write German language
* informed consent (if necessary, informed consent of the parents)
Exclusion Criteria
* severe organic disease preventing a regular participation in the training course
* pregnancy
* severe cognitive impairment
* current treatment of psychiatric disorder
* renal disease requiring dialysis
16 Years
75 Years
ALL
No
Sponsors
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Berlin-Chemie
UNKNOWN
Norbert Hermanns
OTHER
Responsible Party
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Norbert Hermanns
CEO
Principal Investigators
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Norbert Hermanns, PhD
Role: PRINCIPAL_INVESTIGATOR
Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)
Locations
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Diabetologische Schwerpunktpraxis Neuss
Neuss, , Germany
Countries
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References
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Ehrmann D, Kulzer B, Schipfer M, Lippmann-Grob B, Haak T, Hermanns N. Efficacy of an Education Program for People With Diabetes and Insulin Pump Treatment (INPUT): Results From a Randomized Controlled Trial. Diabetes Care. 2018 Dec;41(12):2453-2462. doi: 10.2337/dc18-0917. Epub 2018 Oct 10.
Other Identifiers
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NH012016
Identifier Type: -
Identifier Source: org_study_id