Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| optimal injection technique | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| training in optimal insulin injection technique | Behavioral | the training will be delivered in person as well as through online training modules via the BD and Me(TM) platform |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christophe De Block, MD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Antwerpen | Antwerp | Belgium | ||||
| Imeldaziekenhuis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Bonheiden |
| Belgium |
| Universitair Ziekenhuis Brussel | Brussels | Belgium |
| UZ Gent | Ghent | Belgium |
| Virga Jesse Ziekenhuis | Hasselt | Belgium |
| AZ Groeninge | Kortrijk | Belgium |
| AZ Nikolaas | Sint-Niklaas | Belgium |
| AZ Turnhout | Turnhout | Belgium |
| AZ Jan Portaels | Vilvoorde | Belgium |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided