Innovative Insulin Injection Sites Map to Minimize Lipohypertrophy Risk

Brief summary (registry, in English)

Background: Patients on long-term insulin therapy frequently develop a condition called lipohypertrophy (LH), which involves the accumulation of abnormal fatty tissue at insulin injection sites. This condition is caused by repeated injections in the same area and can lead to inconsistent insulin absorption, unpredictable blood sugar levels, and increased risks of hypoglycemia and hyperglycemia. While standard care often includes verbal instructions on site rotation, many patients continue to struggle with technique and develop these complications. Study Purpose: This study aims to evaluate the effectiveness of a novel "Insulin Injection Sites Map" (provided in either digital or physical format) compared to standard verbal care. The study seeks to determine if this structured, visual mapping tool helps patients better manage their injection rotation, reduces the occurrence and severity of lipohypertrophy, and ultimately improves glycemic control (as measured by HbA1c and fasting blood glucose). Study Design: This is a prospective, randomized controlled trial (RCT) conducted at the outpatient medical clinic of Matrouh General Hospital. The study includes adult participants (aged 18 and older) diagnosed with Type 1 or Type 2 diabetes who have been using insulin therapy for at least six months. Participants are divided into two groups: Intervention Group: Patients who receive the novel structured insulin injection sites map and instructions on systematic rotation. Control Group: Patients who receive routine care, consisting of standard verbal instructions on site rotation without visual mapping aids. Outcome Measures: Over a six-month follow-up period, the study monitors and compares both groups on the following key metrics: Incidence and Severity of Lipohypertrophy: Evaluated through physical inspection and palpation of injection sites for lumps, firmness, or tenderness. Adherence to Rotation Protocols: Measured using patient logs and site rotation scores to determine if participants are following the recommended rotation sequence. Glycemic Control: Tracked through clinical monitoring of HbA1c percentages and fasting blood glucose levels to assess the impact of better injection technique on overall diabetes management.

What you commit to

• Study type: Interventional
• Participants enrolled: 170
• From 1 Jun 2025 to the primary completion date, 30 Jan 2026
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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