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

M

Mansoura University

Status

Completed

Conditions

Insulin Dependent Diabetes Mellitus

Treatments

Procedure: Group(1) Insulin site injection map

Study type

Interventional

Funder types

Other

Identifiers

NCT07375875
0307290 Faculty of medicine, A

Details and patient eligibility

About

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

Full 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

Enrollment

170 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

170 participants in 2 patient groups

Group(1)
Active Comparator group
Description:
Insulin site injection map
Treatment:
Procedure: Group(1) Insulin site injection map
Group two
No Intervention group
Description:
Routine hospital care with continuous follow up

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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