AzTrials
AzTrials

Diabetes MellitusINPUTNCT02868931

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

A study testing INPUT in people with Diabetes Mellitus, run by Norbert Hermanns at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
INPUT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
268 participants
Where
1 siteGermany
Study dates
1 Apr 2016to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Germany1 site

  • Diabetologische Schwerpunktpraxis Neuss

    Neuss, 41462

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
INPUT
Keywords
self-management, empowerment, treatment and education program, insulin pump, diabetes education
Medical subject headings
Diabetes Mellitus, Empowerment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INPUTBehavioural

    Also called treatment and education program for INsulin PUmp Therapy

    Treatment and education program based on the self-management theory of behavioral medicine.

    The program is delivered by certified and specially trained diabetes educators.

Study groups in NCT02868931
Study groupRoleWhat they receive
INPUTExperimentalINPUT 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.
Receives: Behavioral: INPUT
Waiting listNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Glycemic Control Measured by A1c

    Difference between baseline A1c and A1c at the 6-month follow-up

    Measured: 6 months

Secondary outcomes (10)

  1. 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.

    Measured: 6 months

  2. Diabetes Empowerment

    Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. 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

    Measured: 6 months

  6. Problem Areas in Diabetes

    The Problem Areas in Diabetes Scale (PAID) assesses the psychosocial adaptation to the burden of living with and treating diabetes.

    Measured: 6 months

  7. 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

    Measured: 6 months

  8. Depressive symptoms

    The presence and extent of typical depressive symptoms are assessed via self-report

    Measured: 6 months

  9. 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)

    Measured: 6 months

  10. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2016 (estimated)
  2. Study start1 Apr 2016
  3. Primary completionFeb 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02868931
Sponsor's protocol ID
NH012016
Acronym
INPUT
Status last verified
Nov 2017
First submitted
20 Apr 2016
Last updated
28 Nov 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30305343

Questions about this trial

What is this clinical trial studying?

A study testing INPUT in people with Diabetes Mellitus, run by Norbert Hermanns at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Glycemic Control Measured by A1c (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02868931, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in