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

November 24, 2017 updated by: Norbert Hermanns

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
268

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, 41462
        • Diabetologische Schwerpunktpraxis Neuss

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.

Other Names:
  • treatment and education program for INsulin PUmp Therapy
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Glycemic Control Measured by A1c
Time Frame: 6 months
Difference between baseline A1c and A1c at the 6-month follow-up
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hypoglycaemia Awareness
Time Frame: 6 months
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
Diabetes Empowerment
Time Frame: 6 months
Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
6 months
Problem Areas in Diabetes
Time Frame: 6 months
The Problem Areas in Diabetes Scale (PAID) assesses the psychosocial adaptation to the burden of living with and treating diabetes.
6 months
Satisfaction with current treatment
Time Frame: 6 months
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
Diabetes Self-Management
Time Frame: 6 months
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
Diabetes Distress
Time Frame: 6 months
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
Health-related Quality of Life
Time Frame: 6 months
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
Depressive symptoms
Time Frame: 6 months
The presence and extent of typical depressive symptoms are assessed via self-report
6 months
Attitudes towards insulin pump therapy
Time Frame: 6 months
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
Severe hypoglycaemia
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norbert Hermanns

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Berlin-Chemie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NH012016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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