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

Not Applicable

Terminated

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Behavioral: training in optimal insulin injection technique

• Registration Number: NCT04007003
• Lead Sponsor: Becton, Dickinson and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-26
• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-05
• Primary Completion: 2019-08-10
• Study Completion: 2019-08-10
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 170

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
optimal injection technique	training in optimal insulin 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

Primary Outcome Measures

Name	Time	Method
Change in Insulin Use	up to 6 months	Change in Total Daily Dose of insulin for subjects at baseline and after 6 months; expressed as % and units/24 hrs

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerpen, Belgium

Imeldaziekenhuis; 🇧🇪 Bonheiden, Belgium

Universitair Ziekenhuis Brussel; 🇧🇪 Brussel, Belgium

Virga Jesse Ziekenhuis; 🇧🇪 Hasselt, Belgium

AZ Turnhout; 🇧🇪 Turnhout, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, Belgium

AZ Nikolaas; 🇧🇪 Sint-Niklaas, Belgium

AZ Jan Portaels; 🇧🇪 Vilvoorde, Belgium