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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07375875
Enrollment
170
Registered
2026-01-29
Start date
2025-05-15
Completion date
2025-12-15
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Dependent Diabetes Mellitus

Keywords

Strategies; Insulin; Injection; Hypertrophy; Map

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

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

Interventions

PROCEDUREGroup(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"

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Decrease Lipohypertrophy6 monthsinsulin induced lipohypertrophy

Countries

Egypt

Contacts

STUDY_DIRECTORHala Mohamed Abdelhamed, Assis.prof

Faculty of Nursing, Mansoura university

STUDY_DIRECTORHoda Eldeeb, Assis.prof

Faculty of nursing, ِAlexandria University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026