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临床试验/CTRI/2025/11/098027
CTRI/2025/11/098027招募中不适用

Evaluation of the Effectiveness of Insulin Injection Technique Education on Glycemic Control in Geriatric Patients with Type 2 Diabetes Mellitus- A prospective, randomized, controlled, parallel-group interventional study

未提供1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2025年12月3日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
124
试验地点
1
主要终点
To measure improvement in HbA1c at 3- and 6- months following structured insulin injection technique education.

研究概览

简要总结

Geriatric patients with T2DM face unique barriers to effective insulin self-administration due to age-associated factors such as cognitive decline, poor vision, tremors, and polypharmacy. These challenges often result in improper injection practices like site reuse, incorrect angles, and needle reuse, which contribute to complications such as lipohypertrophy, poor insulin absorption, and suboptimal glycemic control. Despite the availability of international guidelines, educational interventions remain underutilized in Indian clinical settings, especially in the older adults. This study aims to assess whether structured, tailored, and reinforced education can translate into better clinical and behavioral outcomes for this vulnerable population.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
65.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed with T2DM Currently on insulin therapy (stable dose) for at least 6 months Capable of insulin self-administration or caregiver availability for insulin administration Able to provide informed written consent.

排除标准

  • Terminal illness or clinical frailty scores more than 7 Recent structured insulin education within 6 months.

结局指标

主要结局

To measure improvement in HbA1c at 3- and 6- months following structured insulin injection technique education.

时间窗: To measure improvement in HbA1c at 3- and 6- months following structured insulin injection technique education.

次要结局

  • 1. To assess the baseline knowledge of insulin injection techniques in geriatric diabetic patients.(2. To measure improvement in FBS (Fasting blood sugar), PPB Post prandial blood sugar) & Total Daily Dosing of insulin at 3- & 6- months following structured insulin injection technique education.)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Nidhi Soni

AIIMS New Delhi

研究点 (1)

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