| CTRI Number |
CTRI/2024/02/063351 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare the effects of health related technology on monitoring of blood glucose by self in patients with high blood sugar levels in Aligarh |
|
Scientific Title of Study
|
Augmentation Of Self Monitoring Of Blood Glucose With Digital Therapeutic Intervention In Patients With Type 2 Diabetes In Urban Aligarh: A Randomized Controlled Trial |
| 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. Chelsea |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Musim University |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, AMU Campus, Dhaurra Mafi, Medical Road, Aligarh, Uttar Pradesh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7034227388 |
| Fax |
|
| Email |
chelsea.4397@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mohammad Salman Shah |
| Designation |
Assisstant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, AMU Campus, Dhaurra Mafi, Medical Road, Aligarh, Uttar Pradesh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7453001978 |
| Fax |
|
| Email |
salmanshah78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Chelsea |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, AMU Campus, Dhaurra Mafi, Medical Road, Aligarh, Uttar Pradesh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7034227388 |
| Fax |
|
| Email |
chelsea.4397@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Community Medicine, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, AMU Campus, Dhaurra Mafi, Medical Road, Aligarh, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Chelsea |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, AMU Campus, Dhaurra Mafi, Medical Road, Aligarh, Uttar Pradesh |
| 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 Chelsea |
Urban Health Training Centre, Jawaharlal Nehru Medical College, Aigarh Muslim University |
UHTC,Department of Community Medicine, JNMCH, AMU, Shafi Rd, Purani Chungi, AMU Campus, Aligarh, Uttar Pradesh 202001
Aligarh
UTTAR PRADESH |
7034227388
chelsea.4397@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nheru Medical College, Aligarh Muslim University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Digital Therapeutic Intervention |
Study participants will be divided into 3 arms- (1) Those who do not use SMBG (2) those who use SMBG three times a
week and (3) thrice weekly SMBG users who would receive feedbacks in the form of digital application
including tailored messages. This study will be conducted over a period of 6 months with recording of baseline information, follow-up at 3 months and 6 months. |
| Comparator Agent |
Self Monitoring of blood glucose |
Study participants will be divided into 3 arms- (1) Those who do not use SMBG (2) those who use SMBG three times a week and (3) thrice weekly SMBG users who would receive feedbacks in the form of digital application including tailored messages. This study will be conducted over a period of 6 months with recording of baseline information, follow-up at 3 months and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All diabetic patients between 30-65 years, on treatment with diet and oral hypoglycemic agents
(OHA) in the urban areas of Aligarh.
2. All those who will give consent.
3. Those who have compatible smartphones and literacy for application usage. |
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Those in immunocompromised state, palliative care and seriously ill patients. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Attainment of glycemic control-FBS, PPBS, HbA1C
2)Lifestyle habits- Diet,physical activity, sleep, stress
3)Adherence to treatment |
Baseline, 3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)anthropometric parameter- BMI
2)prevention of hypoglycemia |
Baseline, 3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Diabetes mellitus, being one of the greatest contributors of global burden, has necessitated a holistic perspective for its treatment and prevention and not merely pharmacological therapy. Self monitoring of Blood glucose encompasses all the fundamental principles and approaches of Diabetic management and care. As digital revolution in the field of health is affecting and reshaping the healthcare system worldwide, application of novel digital innovation in
SMBG can improve the quality of care. There is a need for continuous improvisation and research in this developing sector with multiple guidelines.
Studies that had SMBG on a daily basis have had inconclusive findings and proved to be cumbersome while weekly SMBG had been found ineffective. By doing a thrice weekly study, the process is expected to be user-friendly as well as to mitigate the potential limitations found in the previous study.
|