| CTRI Number |
CTRI/2025/11/098027 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Insulin Injection Technique Education on Blood sugar control in Geriatric Patients with Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidhi Soni |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Geriatric Medicine
National Centre for Ageing
AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8527118534 |
| Fax |
|
| Email |
nidhisoni1962@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Soni |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Geriatric Medicine
National Centre for Ageing
AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8527118534 |
| Fax |
|
| Email |
nidhisoni1962@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Soni |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Geriatric Medicine
National Centre for Ageing
AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8527118534 |
| Fax |
|
| Email |
nidhisoni1962@gmail.com |
|
|
Source of Monetary or Material Support
|
| The study is coonducted at Geriatric Outpatient Department (OPD), All India Institute of Medical Sciences (AIIMS), New Delhi, India. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
Geriatric Outpatient Department (OPD), All India Institute of Medical Sciences (AIIMS), New Delhi, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nidhi Soni |
Department of Geriatric Medicine |
National Centre for Ageing
AIIMS New Delhi
New Delhi
DELHI |
8527118534
nidhisoni1962@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine care |
Participants will continue with routine care as provided in the outpatient setting, which may include unstructured brief advice from the treating physician, but no dedicated or standardized education session. |
| Intervention |
Structured Insulin Injection Technique Education |
Delivered by a trained diabetes educator
- 30-minute interactive session with demonstration using models and insulin pens
- Visual aids, culturally appropriate handouts, and vernacular language materials will be provided
- Topics include injection site selection, site rotation, hygiene, needle reuse, insulin storage, injection angle, and recognition/prevention of lipohypertrophy
|
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
Terminal illness or clinical frailty scores more than 7
Recent structured insulin education within 6 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure improvement in HbA1c at 3- and 6- months following structured insulin injection technique education. |
To measure improvement in HbA1c at 3- and 6- months following structured insulin injection technique education. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
3. To evaluate the retention of knowledge post-education through standardized questionnaires.
4. To identify patients requiring reinforcement, factors associated with poor compliance & assess the impact of re-counselling.
|
onset,3 months,6 months |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |