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

Becton, Dickinson and Company (BD)

Status: Terminated

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Treatments: Behavioral: training in optimal insulin injection technique

Study type: Interventional

Funder types: Industry

Identifiers

NCT04007003

LiMo Audit

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

optimal injection technique

Experimental group

Description:

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

Treatment:

Behavioral: training in optimal insulin injection technique