| CTRI Number |
CTRI/2017/03/008206 [Registered on: 27/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
24/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Provision of free of cost medical supplies] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Social and educational assistance for improved outcome of Childhood Diabetes Mellitus |
|
Scientific Title of Study
|
Childhood Diabetes - A community approach for improved long term outcome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijayalakshmi Bhatia |
| Designation |
Professor |
| Affiliation |
Department of Endocrinology, SGPGIMS |
| Address |
Room 114, Department of Endocrinology, SGPGIMS, Raebareli Road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
91-522-2494380 |
| Fax |
|
| Email |
bhatiaviji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalakshmi Bhatia |
| Designation |
Professor |
| Affiliation |
Department of Endocrinology, SGPGIMS |
| Address |
Room 114, Department of Endocrinology, SGPGIMS, Raebareli road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
91-522-2494380 |
| Fax |
|
| Email |
bhatiaviji@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayalakshmi Bhatia |
| Designation |
DM student |
| Affiliation |
Department of Endocrinology, SGPGIMS |
| Address |
Room 114, Department of Endocrinology, SGPGIMS, Raebareli road, Lucknow
Dr Aditi chopra, Endocrinology Ward, G Block, SGPGIMS, Raebareli road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
|
| Fax |
|
| Email |
bhatiaviji@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology, SEED division, Ministry of Science and Technology, Technology Bhavan, New Mehrauli Road, Delhi 110016 |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology SEED division |
| Address |
Technology Bhavan, New Mehrauli road, New Delhi-110016 |
| Type of Sponsor |
Government funding agency |
|
|
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 Vijayalakshmi Bhatia |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
Room 114, Department of endocrinology, SGPGIMS, Raebareli Road
Lucknow
UTTAR PRADESH |
05222494380
vbhatia@sgpgi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 80th Institutional Ethics Committee of SGPGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 1 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Free of cost provision of medical supplies |
Free of cost provision of medical supplies routinely used by children with Type 1 diabetes mellitus |
| Comparator Agent |
Standard care in our pediatric endocrine clinic |
Standard care in our pediatric endocrine clinic |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients with duration of type 1 diabetes mellitus more than 18 months belonging to middle and low socio-economic status with 6 month follow up in pediatric endocrinology clinic |
|
| ExclusionCriteria |
| Details |
no micro or macro-vascular complications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycemic control |
baseline and every 3 months for 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of self monitored blood glucose readings, episodes of hypo and hyperglycemia and diabetes knowledge test score |
baseline and every 3 months for 1 year for all, test score at baseline, 6 months and 1 year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/03/2017 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Provision of diabetes management supplies, diabetes education and intensive pro-active communication by the diabetes management team may (or may not) improve measures of long term blood glucose control. This hypothesis is being tested by this study. |