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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Behavioral: training in optimal insulin injection technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: optimal injection technique<br>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<br>* the training will be delivered in person as well as through online training modules via the BD and Me(TM) platform<br>|

What is the study measuring?
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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 |