| CTRI Number |
CTRI/2020/02/023115 [Registered on: 04/02/2020] Trial Registered Prospectively |
| Last Modified On: |
27/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Smart Phone Application ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Smart Phone Application in the management of Diabetes Patients |
|
Scientific Title of Study
|
“Medical Technology Based Smartphone Application in the Management of Diabetes Mellitus†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUNIL KUMAR D |
| Designation |
Associate Professor |
| Affiliation |
JSS Medical College |
| Address |
Dept. of Community Medicine,
JSS Medical College, JSS Academy of Higher Education & Research, Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
9035880000 |
| Fax |
|
| Email |
sunilkumard@jssuni.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
SUNIL KUMAR D |
| Designation |
Associate Professor |
| Affiliation |
JSS Medical College |
| Address |
Dept. of Community Medicine,
JSS Medical College, JSS Academy of Higher Education & Research, Mysuru
KARNATAKA
570015
India |
| Phone |
9035880000 |
| Fax |
|
| Email |
sunilkumard@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SUNIL KUMAR D |
| Designation |
Associate Professor |
| Affiliation |
JSS Medical College |
| Address |
Dept. of Community Medicine,
JSS Medical College, JSS Academy of Higher Education & Research, Mysuru
KARNATAKA
570015
India |
| Phone |
9035880000 |
| Fax |
|
| Email |
sunilkumard@jssuni.edu.in |
|
|
Source of Monetary or Material Support
|
| JSS Medical College JSS Academy of Higher Education Research |
|
|
Primary Sponsor
|
| Name |
JSS Medical College JSS Academy of Higher Education Research |
| Address |
JSS Medical College, JSS Academy of Higher Education & Research, SS Nagar, Mysuru |
| Type of Sponsor |
Private medical college |
|
|
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 |
| SUNIL KUMAR D |
JSS Hospital |
Dept. of Community Medicine,
JSS Hospital, Mysuru.
Mysore
KARNATAKA |
9035880000
sunilkumard@jssuni.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committiee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROL GROUP |
Patients in the control group were asked to
continue with their usual care, as a visit to their primary diabetes health care practitioner. |
| Intervention |
DIAGURU-SMART PHONE APPLICATION |
Patients in both the groups were asked to
continue with their usual care, as a visit to their primary diabetes health care practitioner.
Additionally, patients allocated to the intervention arm were given instructions to download the
android Smartphone application named ‘Diaguru’, which was developed by the research team.
The app provided the users with a simple interface having many features to help them in the
management of diabetes through smartphones. The values of the sugar level, insulin level and the
type of food intake could be given as input. The app was automated to alert the user if the values
were not in the normal range. The prescription given by the Doctor was stored using the app and
was programmed to notify the user to take medicines on time. The caloric value of the food
intake could be computed when the user selects the type of food he had consumed which were
available under the categories such as breakfast, lunch, snacks and dinner. Based on his sugar
level and the caloric count, the user was be advised about the calories he required to take in a
day. Reports and graphs were generated by the application to give them a clear idea of blood
sugar levels. The app also answered FAQs and provided tips and references. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1. Patients aged 18-65 years, diagnosed with type II Diabetes Mellitus more than one year ago.
2. Patients with HbA1c >7.5%
3. Patients receiving treatment with oral hypo glycemic drugs
4. Patients who own an android Smartphone.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Patients with severe complications
2. Pregnant women
3. Patients who are not capable of using a Smartphone application.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The evidence in terms of reduction in HbA1c levels in the study group
and also there is an increase in HbA1c levels in the control group. |
The HbA1c levels will be assessed at the intervals of 6 Month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The quality of life which
has four domains like psychological, social, environmental and physical aspects of health also
showed positive correlation in the study group of this trial. This provided evidence based
technological approach and can serve as a model for the upcoming national programs for the
policy makers in management of diabetes mellitus. |
The HbA1c Levels will be assesed at the time interval of 6 Month.
The quality of life also at the end of 6 month. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
06/02/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The novel attempt for a smartphone application based intervention in the management of
type II Diabetes mellitus in India. This project of technology-based non-pharmacological and
lifestyle modification measures blended together for the glycemic control among diabetic
subjects showed about the evidence in terms of reduction in HbA1c levels in the study group
and also there is an increase in HbA1c levels in the control group. The quality of life which
has four domains like psychological, social, environmental and physical aspects of health also
showed a positive correlation in the study group of this trial. This provided evidence-based
technological approach and can serve as a model for the upcoming national programs for the
policymakers in the management of diabetes mellitus. |