NCT02868931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 28, 2017

Status Verified

November 1, 2017

Enrollment Period

10 months

First QC Date

April 20, 2016

Last Update Submit

November 24, 2017

Conditions

Diabetes Mellitus

Keywords

self-managementempowermenttreatment and education programinsulin pumpdiabetes education

Outcome Measures

Primary Outcomes (1)

  • Changes in Glycemic Control Measured by A1c

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

    6 months

Secondary Outcomes (10)

  • Hypoglycaemia Awareness

    6 months

  • Diabetes Empowerment

    6 months

  • Satisfaction with current treatment

    6 months

  • Diabetes Self-Management

    6 months

  • Diabetes Distress

    6 months

  • +5 more secondary outcomes

Study Arms (2)

INPUT

EXPERIMENTAL

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

Waiting list

NO INTERVENTION

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

Interventions

INPUTBEHAVIORAL

Treatment and education program based on the self-management theory of behavioral medicine. The program is delivered by certified and specially trained diabetes educators.

Also known as: treatment and education program for INsulin PUmp Therapy
INPUT

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetologische Schwerpunktpraxis Neuss

Neuss, 41462, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30305343DERIVED

MeSH Terms

Conditions

Diabetes MellitusEmpowerment

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSocial BehaviorBehavior

Study Officials

  • Norbert Hermanns, PhD

    Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
CEO

Study Record Dates

First Submitted

April 20, 2016

First Posted

August 16, 2016

Study Start

April 1, 2016

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

November 28, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)