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

Study Overview

• Status: Completed
• Conditions: Insulin Dependent Diabetes Mellitus
• Intervention / Treatment: Procedure: Group(1) Insulin site injection map

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Mansurah, Egypt
    • faculty of nursing, Mansoura university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group(1); Insulin site injection map	Procedure: Group(1) Insulin site injection map; 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"
No Intervention: Group two; Routine hospital care with continuous follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease Lipohypertrophy	insulin induced lipohypertrophy	6 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Hala Mohamed Abdelhamed, Assis.prof, faculty of nursing, Mansoura university; Study Director: Hoda Eldeeb, Assis.prof, Faculty of Nursing, Alexandria University

Publications and helpful links

General Publications

• • American Diabetes Association Professional Practice Committee; 6. Glycemic Goals and Hypoglycemia: Standards of Care in Diabetes-2024. Diabetes Care 1 January 2024; 47 (Supplement_1): S111-S125. https://doi.org/10.2337/dc24-S006 • Bavuma, C. M., Musafiri, S., Rutayisire, P. C., Ng'ang'a, L. M., McQuillan, R., & Wild, S. H. (2020). Socio-demographic and clinical characteristics of diabetes mellitus in rural Rwanda: time to contextualize the interventions? A cross-sectional study. BMC endocrine disorders, 20(1), 180. https://doi.org/10.1186/s12902-020-00660-y • Blanchard, J., Ahmed, S., Clark, B., Sanchez Cotto, L., Rangasamy, S., & Thompson, B. (2024). Design and Testing of a Smartphone Application for Real-Time Tracking of CSII and CGM Site Rotation Compliance in Patients With Type 1 Diabetes. Journal of Diabetes Science and Technology, 18(4), 937-945.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Strategies; Insulin; Injection; Hypertrophy; Map
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathological Conditions, Anatomical; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperinsulinism; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Hypertrophy; Diabetes Mellitus, Type 1; Insulin Resistance
• Other Study ID Numbers: 0307290 Faculty of medicine, A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No