An Audit of the Impact of Tailored Information Delivered Via a Digital Learning Platform

NCT ID: NCT04007003

Last Updated: 2019-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-26

Study Completion Date

2019-08-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study intends to audit the impact of optimal insulin injection technique on clinical parameters and self-care behaviour of insulin treated diabetes patients in a prospective manner with a follow-up of 6 months. The optimal injection technique is delivered through education via a multimodal tailored approach augmented with a digital 'tailorable' patient learning platform .

The study is conducted in multiple sites across Belgium. Diabetes patients with or without lipohypertrophy will be entered into the audit. The end points will include the impact on use of insulin, long term blood glucose control (HbA1c), hypoglycaemia, glucose variability, needle reuse, patient injection habits and clinician education, training and information inputs.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

optimal injection technique

Subjects will be trained on site regarding optimal insulin injection technique, including avoiding injections in lipohypertrophy areas and proper rotation. Furthermore subjects are provided with access codes to watch online training modules on the Becton Dickinson (BD) and Me(TM) platform

Group Type EXPERIMENTAL

training in optimal insulin injection technique

Intervention Type BEHAVIORAL

the training will be delivered in person as well as through online training modules via the BD and Me(TM) platform

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

training in optimal insulin injection technique

the training will be delivered in person as well as through online training modules via the BD and Me(TM) platform

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Type 1 Diabetes Mellitus, or Type 2 Diabetes Mellitus
* Injecting insulin for at least 1 year
* Self-managing injection therapy, including daily glucose monitoring
* Access to a device with internet
* Confident in navigating the internet

Exclusion Criteria

* Pregnant or likely to become pregnant during study period
* Impaired cognitive ability which would prevent informed consent
* Syringe only user
* Insulin pump user
* Glucagon-Like Peptide (GLP)-1 receptor agonists therapy only
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Becton, Dickinson and Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christophe De Block, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitair Ziekenhuis Antwerpen

Antwerp, , Belgium

Site Status

Imeldaziekenhuis

Bonheiden, , Belgium

Site Status

Universitair Ziekenhuis Brussel

Brussels, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

Virga Jesse Ziekenhuis

Hasselt, , Belgium

Site Status

AZ Groeninge

Kortrijk, , Belgium

Site Status

AZ Nikolaas

Sint-Niklaas, , Belgium

Site Status

AZ Turnhout

Turnhout, , Belgium

Site Status

AZ Jan Portaels

Vilvoorde, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LiMo Audit

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Diabetes Coaching Study
NCT02066831 COMPLETED NA
Diabetes Management Personal Trainer
NCT00340093 COMPLETED PHASE1