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Completed

NCT Number: NCT07561086

Innovative Insulin Injection Sites Map to Minimize Lipohypertrophy Risk

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Matruh General Hospital

Marsá Maţrūḩ, Mersa Matrouh, 51511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin Injection Site Mapping Tool

Behavioral

Participants receive an evidence-based insulin injection site mapping tool designed to guide systematic rotation of insulin injection sites and reduce the risk of insulin-induced lipohypertrophy. The intervention is supported by structured education and follow-up reinforcement.

Primary outcomes

  1. Incidence of Insulin-Induced Lipohypertrophy

    Time frame: Baseline, 3 months, and 6 months post-intervention

    Description:

    The primary outcome is the incidence of insulin-induced lipohypertrophy at injection sites, assessed by trained clinical evaluation using visual inspection and palpation.

  2. Adherence to Insulin Injection Site Rotation

    Time frame: Baseline, 3 months, and 6 months

    Assessment of participant adherence to recommended insulin injection site rotation protocol.

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

Strategy for Minimize the Risk for Insulin Induced Lipohypertrophy and Its Related Consequences: Innovative Insulin Injection Sites Map

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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