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临床试验/NCT07375875
NCT07375875已完成不适用

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

Mansoura University1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2025年5月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
1
主要终点
Decrease Lipohypertrophy

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • 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

排除标准

  • 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.

研究组 & 干预措施

Group(1)

Active Comparator

Insulin site injection map

干预措施: Group(1) Insulin site injection map (Procedure)

Group two

No Intervention

Routine hospital care with continuous follow up

结局指标

主要结局

Decrease Lipohypertrophy

时间窗: 6 months

insulin induced lipohypertrophy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Fathallah Mostafa

professor of critical and emergency nursing

Mansoura University

研究点 (1)

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