Strategies to Minimize the Risk for Insulin Induced Hypertrophy and Its Related Consequences

Hypertrophy caused by insulin has effects that extend beyond just aesthetic concerns. Innovative methods have shown potential in decreasing the chances of hypertrophy and its related issues, including the development of detailed diagrams of insulin injection locations and tailored rotation plans. This study aimed to assess the impact of a novel insulin injection sites map (digital or physical) on the incidence of insulin-induced hypertrophy, adherence to rotation protocols, glycemic control, and patient experience among diabetes patients treated with insulin between study and control group along six months of follow up

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Key information

Conditions

Insulin Dependent Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypertrophy Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of nursing, Mansoura university

Al Mansurah, Egypt

About this study

Patients on long-term insulin therapy frequently experience significant side effect of insulin-induced hypertrophy, particularly lipohypertrophy (LH).Nurses play a crucial role as direct care providers and educators for diabetes patients, ensuring the safe administration of insulin and preventing insulin-related hypertrophy. This research aims to explore and evaluate innovative mapping methods for insulin injection locations due to the rising prevalence of diabetes in Egypt and the United States, alongside the considerable effect that insulin-induced hypertrophy has on patient results and healthcare systems

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

• Type 1 or type 2 diabetes mellitus in adults (≥18 years old).

Insulin therapy has been administered for a minimum of six months.
Self-injecting insulin and assisted injection on a regular basis

Exclusion criteria

Patients with mental illnesses or severe cognitive impairment.

Individuals with skin disorders at injection locations such as severe eczema, psoriasis, or infection that could interfere with the evaluation of lipohypertrophy.
Women who are lactating or pregnant.

Treatment and study plan

Group(1) Insulin site injection map

Procedure

The intervention group participants attended a structured educational session focused on strategies to reduce the risk of insulin-induced hypertrophy and its associated consequences, either individually or in small groups . The session included: appropriate insulin injection techniques, since repeated trauma is the main cause of hypertrophy, the researchers explained "standardized rotation protocols and insulin injection sites map"

Primary outcomes

Decrease Lipohypertrophy

Time frame: 6 months

insulin induced lipohypertrophy

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jan 29, 2026
Registry last updated: Jan 29, 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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