An Audit of the Impact of Tailored Information Delivered Via a Digital Learning Platform
Primary Purpose
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
training in optimal insulin injection technique
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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
Sites / Locations
- Universitair Ziekenhuis Antwerpen
- Imeldaziekenhuis
- Universitair Ziekenhuis Brussel
- UZ Gent
- Virga Jesse Ziekenhuis
- AZ Groeninge
- AZ Nikolaas
- AZ Turnhout
- AZ Jan Portaels
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
optimal injection technique
Arm 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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in Glycemic Control
Change in HbA1c for subjects at baseline and after 6 months; expressed as % and mmol/mol
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
Change in Needle Re-Use
Rate of needle re-use by self-reporting at baseline and after 6 months
Full Information
NCT ID
NCT04007003
First Posted
June 6, 2019
Last Updated
December 2, 2019
Sponsor
Becton, Dickinson and Company
1. Study Identification
Unique Protocol Identification Number
NCT04007003
Brief Title
An Audit of the Impact of Tailored Information Delivered Via a Digital Learning Platform
Official Title
An Audit of the Impact of Tailored Information Delivered Via a Digital Learning Platform
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
August 10, 2019 (Actual)
Study Completion Date
August 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Becton, Dickinson and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
optimal injection technique
Arm Type
Experimental
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
training in optimal insulin injection technique
Intervention Description
the training will be delivered in person as well as through online training modules via the BD and Me(TM) platform
Primary Outcome Measure Information:
Title
Change in Insulin Use
Description
Change in Total Daily Dose of insulin for subjects at baseline and after 6 months; expressed as % and units/24 hrs
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Change in Glycemic Control
Description
Change in HbA1c for subjects at baseline and after 6 months; expressed as % and mmol/mol
Time Frame
up to 6 months
Title
Incidence of Hypoglycemic Events
Description
Rate of hypoglycemic events requiring 3rd party assistance in 6 months prior to study start (baseline) and during the 6 months of the study
Time Frame
up to 6 months
Title
Change in Needle Re-Use
Description
Rate of needle re-use by self-reporting at baseline and after 6 months
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe De Block, MD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Antwerpen
City
Antwerpen
Country
Belgium
Facility Name
Imeldaziekenhuis
City
Bonheiden
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Brussel
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
Virga Jesse Ziekenhuis
City
Hasselt
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
Country
Belgium
Facility Name
AZ Nikolaas
City
Sint-Niklaas
Country
Belgium
Facility Name
AZ Turnhout
City
Turnhout
Country
Belgium
Facility Name
AZ Jan Portaels
City
Vilvoorde
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Audit of the Impact of Tailored Information Delivered Via a Digital Learning Platform
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