NCT04007003

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

9 active sites

Status
terminated

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

June 26, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2019

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2019

Completed
Last Updated

December 3, 2019

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

June 6, 2019

Last Update Submit

December 2, 2019

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Change in Insulin Use

    Change in Total Daily Dose of insulin for subjects at baseline and after 6 months; expressed as % and units/24 hrs

    up to 6 months

Secondary Outcomes (3)

  • Change in Glycemic Control

    up to 6 months

  • Incidence of Hypoglycemic Events

    up to 6 months

  • Change in Needle Re-Use

    up to 6 months

Study Arms (1)

optimal injection technique

EXPERIMENTAL

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

Behavioral: training in optimal insulin injection technique

Interventions

training in optimal insulin injection techniqueBEHAVIORAL

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

optimal injection technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Location

Imeldaziekenhuis

Bonheiden, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

UZ Gent

Ghent, Belgium

Location

Virga Jesse Ziekenhuis

Hasselt, Belgium

Location

AZ Groeninge

Kortrijk, Belgium

Location

AZ Nikolaas

Sint-Niklaas, Belgium

Location

AZ Turnhout

Turnhout, Belgium

Location

AZ Jan Portaels

Vilvoorde, Belgium

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Christophe De Block, MD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2019

First Posted

July 5, 2019

Study Start

June 26, 2018

Primary Completion

August 10, 2019

Study Completion

August 10, 2019

Last Updated

December 3, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(9)