Clinical trial NCT02868931: Evaluation of a Diabetes Treatment and Education Program for Insulin Pump Therapy (INPUT)
Official title: Evaluation of a Newly Developed Treatment and Education Program (INPUT) for Diabetic Patients Performing an Insulin Pump Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: self-management
empowerment
treatment and education program
insulin pump
diabetes education
Lead sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim
Sponsor class: OTHER
Collaborators: name: Berlin-Chemie
First posted: 2016-08-16
Enrollment: 268
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Existing insulin pump therapy
* 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:

* Diabetes duration \< 1 year
* severe organic disease preventing a regular participation in the training course
* pregnancy
* severe cognitive impairment
* current treatment of psychiatric disorder
* renal disease requiring dialysis

Primary outcomes:
measure: Changes in Glycemic Control Measured by A1c
timeFrame: 6 months
Secondary outcomes:
measure: Hypoglycaemia Awareness
timeFrame: 6 months
measure: Diabetes Empowerment
timeFrame: 6 months
measure: Satisfaction with current treatment
timeFrame: 6 months
measure: Diabetes Self-Management
timeFrame: 6 months
measure: Diabetes Distress
timeFrame: 6 months
measure: Problem Areas in Diabetes
timeFrame: 6 months
measure: Health-related Quality of Life
timeFrame: 6 months
measure: Depressive symptoms
timeFrame: 6 months
measure: Attitudes towards insulin pump therapy
timeFrame: 6 months
measure: Severe hypoglycaemia
timeFrame: 6 months
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Diabetologische Schwerpunktpraxis Neuss
Study officials:
affiliation: Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)
name: Norbert Hermanns, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.