Innovative Insulin Injection Sites Map to Minimize Lipohypertrophy Risk

Helwan University

Status: Completed

Conditions: Type 1 Diabetes Mellitus; Lipohypertrophy

Treatments: Behavioral: Insulin Injection Site Mapping Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT07561086

00012098

0307290

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18 years and older.
• Diagnosed with Type 1 or Type 2 diabetes mellitus.
• Currently receiving insulin therapy for a minimum of six months.
• Capable of self-injecting insulin or receiving assistance with injections at least once daily.
• Able and willing to provide informed consent to participate in the study.
• Able to understand and follow the study protocols.

Exclusion criteria

• Presence of mental illnesses or severe cognitive impairment that may affect participation.
• Individuals with skin disorders at injection sites (e.g., severe eczema, psoriasis, or infections) that could interfere with the evaluation of lipohypertrophy.
• Women who are pregnant or lactating.
• Participation in another interventional clinical trial within the past three months.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Insulin Injection Site Mapping and Education Program

Experimental group

Description:

Participants in this arm receive an evidence-based insulin injection site mapping tool designed to support systematic rotation of insulin injection sites and reduce the risk of insulin-induced lipohypertrophy, with the aim of improving glycemic control. Interventions: * Provision of an insulin injection site mapping tool (digital or printed format) illustrating recommended rotation patterns * Structured educational sessions on correct insulin injection techniques and site rotation principles * Weekly reinforcement follow-up (e.g., phone calls) to support adherence, address barriers, and reinforce proper injection practices.

Treatment:

Behavioral: Insulin Injection Site Mapping Tool

Standard Diabetes Care for Insulin Injection Technique

No Intervention group

Description:

Participants in this arm receive standard diabetes care related to insulin injection technique, without additional structured tools or enhanced educational support. Interventions: * Routine verbal instructions on insulin injection technique and site rotation as provided in usual clinical practice. * No visual mapping tools, structured education sessions, or follow-up reinforcement.