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

Norbert Hermanns

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Behavioral: INPUT

Study type: Interventional

Funder types: Other

Identifiers

NCT02868931

NH012016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 268 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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268 participants in 2 patient groups

INPUT

Experimental group

Description:

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.

Treatment:

Behavioral: INPUT

Waiting list

No Intervention group

Description:

Patients are randomly assigned to the waiting list. After completion of the 6-month follow-up, these patients will also receive training with INPUT.