NCT04659330

Lipohypertrophy Monitoring Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators intend to audit the impact of optimal injection technique education delivered through a multimodal tailored approach augmented with a digital 'tailorable' patient learning platform on clinical parameters and self-care behaviours of insulin treated patients in a prospective audit with follow-up in 6 months, conducted in multiple sites across Belgium. Diabetes patients with or without lipohypertrophy will be entered into the audit. The end points measured will include the impact on consumption of insulin, long term blood glucose control (HbA1c), hypoglycaemia, glucose variability, needle reuse, patient injection habits and clinician education, training and information inputs.

Detailed description

Principle objective To assess the impact of optimal injection technique education, tailored learning prescription and use of BD Micro-FineTM Ultra 4mm x 32G pen needle upon total daily dose of insulin consumption in patients with or without clinically detectable lipohypertrophy. To assess the cost of intervention vs. direct savings with a view to use of the data in needle reimbursement discussions with the Belgian health care authorities. Secondary objective To assess the impact of the intervention on other parameters of glucose control (including HbA1c, unexplained hypoglycaemia and glycaemic variability). To calculate direct and indirect savings associated with better glucose control. Tertiary objective To assess the impact of the intervention (especially eLearning) on patients' injection technique self-care knowledge and behaviors, including correct site rotation, non-injection into lipohypertrophy and needle reuse patterns. To calculate direct and indirect savings associated with better educational approaches and behavioral changes. Audit Targets and Standards The sample size targeted will be 190 completed patient records. Each center will be asked to contribute between 20-50 subjects. Optimal injection technique and optimal needle length selection are based on Belgian guidelines on Injection, which are based on recently published FITTER worldwide recommendations. A study day will be held for participant nurses to review the protocol and audit forms, and for refresher training in lipohypertrophy detection. Endpoints Total Daily Dose (TDD) of insulin HbA1c (as mmol/mol) Unexplained hypoglycaemic episodes (defined in Entry/Exit Forms) Severe hypoglycaemia (requiring the intervention of a third party) Glycaemic variability (defined in Entry/Exit Forms) Rotation of injection sites with spacing apart of punctures by at least 1 cm Reuse of needles Presence of lipohypertrophy Injections into lipohypertrophic lesions Injection technique practices Adherence to proposed best practice intervention recommendations Data with cost implications (resource usage, hypoglycaemic events) Self-care injection technique knowledge and behaviours Qualitative and quantitative BD and MeTM patient user experience Clinician education, training and information inputs required support behaviour modification and adherence to treatment Quality of Life assessment Unplanned Interventions: ER, Ambulance, Hospital Admission, Critical Cared admission

Conditions

• Diabetes Mellitus
• Lipohypertrophy
• Hypoglycemia

Interventions

Type	Name	Description
BEHAVIORAL	Online education (BdandMe) for injection technique	patients were referred to the relevant modules on BD and Me™ (for online education)
DEVICE	4mm needles	Providing a supply of needles for single use of 4mm insulin injection needle.

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-05-31
• Completion: 2019-12-24
• First posted: 2020-12-09
• Last updated: 2020-12-09

Locations

1 site across 1 country: Belgium