Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
BEHAVIORALtraining 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
Sponsors
Becton, Dickinson and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in Needle Re-Use | up to 6 months | Rate of needle re-use by self-reporting at baseline and after 6 months |
Countries
Belgium
Outcome results
None listed