Lipohypertrophy Monitoring Study

Study Overview
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Brief Summary
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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
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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

Official Title
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Lipohypertrophy Monitoring Study

Conditions
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Diabetes Mellitus, Lipohypertrophy, Hypoglycemia

Intervention / Treatment
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* Behavioral: Online education (BdandMe) for injection technique
* Device: 4mm needles


Participation Criteria
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Eligibility Criteria
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Patient Inclusion Criteria Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Age 18 or above 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 Patient Exclusion Criteria Children <18 years Pregnant or likely to become pregnant during study period Impaired cognitive ability which would prevent informed consent Syringe only user Insulin pump user GLP-1 RA therapy only Patients declining to take part in the study Cannot read and understand Dutch No access to an internet enabled device

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention group<br>All patients underwent intervention | Behavioral: Online education (BdandMe) for injection technique<br>* patients were referred to the relevant modules on BD and Me™ (for online education)<br>Device: 4mm needles<br>* Providing a supply of needles for single use of 4mm insulin injection needle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Primary outcome parameter was the evolution between baseline and end-of-study percentage of needle reuse and injecting in a zone of lipohypertrophy. | 6 months | 
| Severe and unexplained hypoglycemia | Primary outcome parameter was the evolution between baseline and end-of-study percentage of needle reuse and injecting in a zone of lipohypertrophy. Hypoglycemia is defined as the occurrence of ≥ 1 symptom and a confirmed glucose reading ≤60 mg/dl. Unexplained hypoglycemia is defined as hypoglycemia occurring in the absence of a definable precipitating event such as a change in medication, diet or activity. | 6 months | 
| glucose variability | Primary outcome parameter was the evolution between baseline and end-of-study percentage of needle reuse and injecting in a zone of lipohypertrophy. Increased glucose variability was defined as the occurrence of at least 3 times a week glucose values evolving from <60 mg/dl (3.3 mmol/l) to >250 mg/dl (13.9 mmol/l) or vice versa (i.e. a delta >190 mg/dl or 10.6 mmol/l). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin dose in patients with and without lipohypertrophy | Secondary objectives were to evaluate the impact of the use of 4mm pen needles and an educational platform focused on correct injection technique, correct rotation of injection sites, non-injection into lipohypertrophy sites and stopping needle reuse on the insulin dose in patients with and without lipohypertrophy. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lipohypertrophy, online education, insulin injection technique, diabetes mellitus