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

NCT07375875 | Completed

• 1 other identifier: 0307290 Faculty of medicine, A
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insulin Dependent Diabetes Mellitus

Keywords

Strategies; Insulin; Injection; Hypertrophy; Map

Outcome Measures

Primary Outcomes (1)

• Decrease Lipohypertrophy

  insulin induced lipohypertrophy

  6 months

Study Arms (2)

Group(1)

ACTIVE COMPARATOR

Insulin site injection map

Procedure: Group(1) Insulin site injection map

Group two

NO INTERVENTION

Routine hospital care with continuous follow up

Interventions

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"

Group(1)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

faculty of nursing, Mansoura university

Al Mansurah, Egypt

Location

Related Publications (1)

• • 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.

  RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance; Hypertrophy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hala Mohamed Abdelhamed, Assis.prof

  Faculty of Nursing, Mansoura university

  STUDY DIRECTOR

• Hoda Eldeeb, Assis.prof

  Faculty of nursing, ِAlexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of critical and emergency nursing

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 29, 2026
• Study Start: May 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)