- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04007003
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
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Antwerpen, Belgium
- Universitair Ziekenhuis Antwerpen
-
Bonheiden, Belgium
- Imeldaziekenhuis
-
Brussel, Belgium
- Universitair Ziekenhuis Brussel
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Gent, Belgium
- UZ Gent
-
Hasselt, Belgium
- Virga Jesse Ziekenhuis
-
Kortrijk, Belgium
- Az Groeninge
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Sint-Niklaas, Belgium
- AZ Nikolaas
-
Turnhout, Belgium
- Az Turnhout
-
Vilvoorde, Belgium
- AZ Jan Portaels
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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
|
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
Time Frame: 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
|
up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Glycemic Control
Time Frame: up to 6 months
|
Change in HbA1c for subjects at baseline and after 6 months; expressed as % and mmol/mol
|
up to 6 months
|
Incidence of Hypoglycemic Events
Time Frame: 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
|
up to 6 months
|
Change in Needle Re-Use
Time Frame: up to 6 months
|
Rate of needle re-use by self-reporting at baseline and after 6 months
|
up to 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christophe De Block, MD, University Hospital, Antwerp
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LiMo Audit
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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