| CTRI Number |
CTRI/2024/06/068594 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of insulin injection practice education in improving blood sugar control among adult diabetic patients who self administer insulin - A Experimental study
|
|
Scientific Title of Study
|
Effect of patients education regarding appropriate insulin injection practices using skin pad on glycemic status among diabetic patients who self administer insulin in a primary care setting A community based Quasi experimental 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 |
Vaitheswari A |
| Designation |
Post graduate |
| Affiliation |
Indira Gandhi Medical college and Research institute |
| Address |
Indira Gandhi Medical College and Research Institute,
Room No.5
Department of Community Medicine,
Vazhudavur road, Kadhirkamam, Puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9047405436 |
| Fax |
|
| Email |
vaitheswari1694@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Vasudevan |
| Designation |
Professor and Head |
| Affiliation |
Indira Gandhi Medical college and Research institute |
| Address |
Indira Gandhi Medical College and Research Institute,
Room no- 1,
Department of Community Medicine,
Vazhudavur road, Kadhirkamam, Puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9787728177 |
| Fax |
|
| Email |
kavita.udayashankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaitheswari A |
| Designation |
Post graduate |
| Affiliation |
Indira Gandhi Medical college and Research institute |
| Address |
Indira Gandhi medical college and research institute,
Room no:5
Department of Community Medicine,
Vazhudavur Road, kadirkamam
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9047405436 |
| Fax |
|
| Email |
vaitheswari1694@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College and Research Institute,
Vazhudavur road, Kathirkamam, Puducherry-605009, India
|
|
|
Primary Sponsor
|
| Name |
Dr Vaitheswari A |
| Address |
Indira Gandhi medical college and research institute,
Department of Community Medicine,
Room no.5,
Vazhudavur Road,
Kadirkamam,
Pondicherry - 605009 |
| Type of Sponsor |
Other [Self] |
|
|
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 Vaitheswari A |
Indira Gandhi MEdical College and research institute |
Room no-1,
Department of Community Medicine,
Vazhudavur Road,
Kadirkamam
Pondicherry
PONDICHERRY |
9047405436
vaitheswari1694@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Control group patients injection practices are observed at baseline and at the end of the study without any intervention. Their HbA1c will also be checked at baseline,3rd and 6th month. at the end of the study they will also be educated on standard injection techniques. Control group patients are followed up for the period of 6months |
| Intervention |
Insulin injection technique education using skin pad |
Patients will be given injection technique education individually at baseline and followed up for 6months. Patients will be revisited at 3rd month to reinforce injection technique adherence. Their HbA1c will be checked at baseline, 3rd month and 6th month. telephone calls are made every month to ensure adherence. Total duration of intervention - 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Type I and type II diabetic patients above 18years of age and who are enrolled in NCD clinic at HWC
Patients who are on insulin for atleast 6months
Patients who self administers insulin
Patient who gives consent |
|
| ExclusionCriteria |
| Details |
Gestational diabetes
Patients who are on insulin pens
Terminally ill patients who are not able to participate in the study
Self reported Haemoglobinopathies, CKD and chronic liver disease
Patient who are not able to comprehend or have cognitive impairment
Patient who are not available in the house for 3 consecutive visits |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycaemic status(HbA1C) improves post intervention |
At baseline, 12 weeks and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of lipohypertrophy, glycaemic variabiity, change in insulin dosage, injection related adverse events |
At baseline & 6th month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| Date of Study Completion (India) |
23/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The study is planned to be conducted in 2 health and wellness centres (HWC) namely Mettupalayam (Control group) and Lawspet() Intervention group with diabetic patients on insulin who are enrolled in NCD clinic with sample size of 80 i.e 40 in each group. Injection technique assessment will be done for both the groups at baseline and at 6th month. Intervention group will be provided with standard injection technique education using video, flipbook, posters and HbA1c will be checked for both the groups at baseline, 3rd month and at 6th month and compared to find the effectiveness of education intervention. Among participants from both the groups who have achieved satisfactory and unsatisfactory glycaemic control in depth interview will be conducted to explore the reason for the same. |