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

Diabetes Mellitus Clinical Trial

— INPUT  

Official title:

Evaluation of a Newly Developed Treatment and Education Program (INPUT) for Diabetic Patients Performing an Insulin Pump Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868931
• Other study ID #: NH012016
• Status: Completed
• Phase: N/A
• First received: April 20, 2016
• Last updated: November 24, 2017
• Start date: April 1, 2016
• Est. completion date: March 2017

Study information

• Verified date: November 2017
• Source: Forschungsinstitut der Diabetes Akademie Mergentheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Germany	Diabetologische Schwerpunktpraxis Neuss	Neuss

Sponsors (2)

Lead Sponsor	Collaborator
Norbert Hermanns	Berlin-Chemie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Glycemic Control Measured by A1c	Difference between baseline A1c and A1c at the 6-month follow-up	6 months
Secondary	Hypoglycaemia Awareness	The hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness. This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness.	6 months
Secondary	Diabetes Empowerment	Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.	6 months
Secondary	Satisfaction with current treatment	Satisfaction with current treatment is assessed via a 10-item scale. The total score ranges from 10 to 60 with lower scores indicating higher satisfaction.	6 months
Secondary	Diabetes Self-Management	The Diabetes Self-Management Questionnaire is a self-report measure of patients' self-care. The level of self-care is assessed via Likert scales.	6 months
Secondary	Diabetes Distress	The Diabetes Distress Scale (DDS) assesses diabetes-related stressors due to living and treating diabetes. Different aspects of distress are covered: emotional burden, physician-related, regimen-related, diabetes-related interpersonal	6 months
Secondary	Problem Areas in Diabetes	The Problem Areas in Diabetes Scale (PAID) assesses the psychosocial adaptation to the burden of living with and treating diabetes.	6 months
Secondary	Health-related Quality of Life	Health-related quality of life focuses on the health-specific aspects of quality of life and dealing with a chronic condition such as diabetes	6 months
Secondary	Depressive symptoms	The presence and extent of typical depressive symptoms are assessed via self-report	6 months
Secondary	Attitudes towards insulin pump therapy	Specific attitudes towards different aspects of insulin pump therapy are assessed via Likert scales. The questionnaire consists of 6 subscales that can be placed within 4 dimensions: (I) Expectations on insulin pump therapy (subscale: achieving better glycaemic control) (II) Perceived advantages of an insulin pump (subscale: gaining more flexibility) (III) Ease of use (subscales: design + functionality) (IV) Psychosocial effects and barriers (subscales: technological dependence + impaired body image)	6 months
Secondary	Severe hypoglycaemia	The incidence of severe hypoglycaemia in the past six months is assessed via Case Report Forms. Severe hypoglycaemia is defined as requiring third party assistance or medical intervention for treating hypoglycaemia.	6 months