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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04007003
• Other study ID #: LiMo Audit
• Status: Terminated
• Phase: N/A
• Start date: June 26, 2018
• Est. completion date: August 10, 2019

Study information

• Verified date: December 2019
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 170
• Est. completion date: August 10, 2019
• Est. primary completion date: August 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Antwerpen
Belgium	Imeldaziekenhuis	Bonheiden
Belgium	Universitair Ziekenhuis Brussel	Brussel
Belgium	UZ Gent	Gent
Belgium	Virga Jesse Ziekenhuis	Hasselt
Belgium	AZ Groeninge	Kortrijk
Belgium	AZ Nikolaas	Sint-Niklaas
Belgium	AZ Turnhout	Turnhout
Belgium	AZ Jan Portaels	Vilvoorde

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Glycemic Control	Change in HbA1c for subjects at baseline and after 6 months; expressed as % and mmol/mol	up to 6 months
Secondary	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
Secondary	Change in Needle Re-Use	Rate of needle re-use by self-reporting at baseline and after 6 months	up to 6 months