| CTRI Number |
CTRI/2017/08/009284 [Registered on: 07/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
18/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of colour coded charts for blood sugar control, among diabetic patients (60 year or more) in a clinic setting |
|
Scientific Title of Study
|
Effectiveness of colour coded diabetic control monitoring charts among elderly diabetics attending outreach geriatric clinics in rural Karnataka- an open labelled randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Farah N Fathima |
| Designation |
Assistant Professor |
| Affiliation |
St johns Medical College |
| Address |
Department of Community Medicine
St Johns Medical College
Bangalore
India
Bangalore
KARNATAKA
560034
India |
| Phone |
9886894586 |
| Fax |
|
| Email |
doc.farah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neethu George |
| Designation |
Post Graduate Student |
| Affiliation |
St Johns Medical College |
| Address |
Department of Community Medicine
St Johns Medical College
Bangalore
India
Bangalore
KARNATAKA
560034
India |
| Phone |
9902517493 |
| Fax |
|
| Email |
neethumampuzha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neethu George |
| Designation |
Post Graduate Student |
| Affiliation |
St Johns Medical College |
| Address |
Department of Community Medicine
St Johns Medical College
Bangalore
India
Bangalore
KARNATAKA
560034
India |
| Phone |
9902517493 |
| Fax |
|
| Email |
neethumampuzha@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College Research Society, St Johns National Academy of Health Sciences, Sarjapur Road, Bangalore-34,Karnataka, India |
|
|
Primary Sponsor
|
| Name |
St Johns Medical College Research Society |
| Address |
St Johns Medical College Research Society,Bnagalore -560034. India |
| Type of Sponsor |
Research institution |
|
|
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 Farah N Fathima |
In Geriatric clinics conducted in Bangalore Urban District PHCs |
Sarjapura PHC and Dommasandra PHC, Bangalore urban district
Bangalore
KARNATAKA |
9886894586
doc.farah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St Johns National Academy of Health Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetes Mellitus Type 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Colour coded diabetic control monitoring charts |
The chart will depict the current glycemic control status of the patient and will classify patients into “good control†(GRBS 140)-Green colour, “fair control†(GRBS 140-199)-Yellow colour and “poor control†(GRBS200)-Red colour |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with a diagnosis of type 2 diabetes mellitus.
2. Patients who are currently treated with a single or combination of injectable /oral anti diabetic drugs with or without insulin therapy
3. Patients aged more than or equal to 60 years old.
|
|
| ExclusionCriteria |
| Details |
1. Patients with type 1 diabetes
2. Patients with diabetic ketoacidosis and/or hyperosmolar hyperglycemic state
3. Patients who are severely ill
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of color coded diabetic control monitoring charts on glycemic control among elderly diabetics attending outreach geriatric clinics through mean HbA1C value difference(before and after) |
Baseline blood sample will be collected for HbA1C at the commencement of the study and after one year to evaluate the effectiveness of chart |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean difference in the Glycosylated Random Blood Sugar (GRBS)values |
Monthly GRBS monitoring of the patients for one year |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
Final Enrollment numbers achieved (Total)= "144"
Final Enrollment numbers achieved (India)="144" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/09/2015 |
| Date of Study Completion (India) |
30/10/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Completed
Published in Indian Journal of Community Medicine |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized parallel single blinded active controlled study done in India to measure the effectiveness of colour coded diabetic monitoring chart for glycemic control among elderly diabetics .The primary outcome of the study is to measure the mean difference in the HbA1C value between the intervention and control group after one year.The secondary outcome of the study is to measure the mean difference in Glycosylated Random Blood Sugar values in the subjects monthly for one year.
|