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Clinical Trials/CTRI/2025/11/098027
CTRI/2025/11/098027RecruitingNot Applicable

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

Not provided1 site in 1 country124 target enrollmentStarted: December 3, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
124
Locations
1
Primary Endpoint
To measure improvement in HbA1c at 3- and 6- months following structured insulin injection technique education.

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
65.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Not provided
Responsible Party
Principal Investigator
Principal Investigator

Dr Nidhi Soni

AIIMS New Delhi

Study Sites (1)

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