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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Intervention / Treatment: Behavioral: training in optimal insulin injection technique

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
    • Universitair Ziekenhuis Antwerpen
  • Bonheiden, Belgium
    • Imeldaziekenhuis
  • Brussel, Belgium
    • Universitair Ziekenhuis Brussel
  • Gent, Belgium
    • UZ Gent
  • Hasselt, Belgium
    • Virga Jesse Ziekenhuis
  • Kortrijk, Belgium
    • Az Groeninge
  • Sint-Niklaas, Belgium
    • AZ Nikolaas
  • Turnhout, Belgium
    • AZ Turnhout
  • Vilvoorde, Belgium
    • AZ Jan Portaels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycemic Control	Change in HbA1c for subjects at baseline and after 6 months; expressed as % and mmol/mol	up to 6 months
Incidence of Hypoglycemic Events	Rate of hypoglycemic events requiring 3rd party assistance in 6 months prior to study start (baseline) and during the 6 months of the study	up to 6 months
Change in Needle Re-Use	Rate of needle re-use by self-reporting at baseline and after 6 months	up to 6 months

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Investigators: Principal Investigator: Christophe De Block, MD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2018
• Primary Completion (Actual): August 10, 2019
• Study Completion (Actual): August 10, 2019

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: December 2, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: LiMo Audit

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No