| CTRI Number |
CTRI/2024/02/062647 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of continuous glucose monitoring device on diabetes patient |
|
Scientific Title of Study
|
Efficacy of continuous glucose monitoring for glycaemic control over standard treatment and monitoring in individuals with uncontrolled type 2 diabetes in Khordha district: A randomized control 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 |
Priyamadhaba Behera |
| Designation |
Associate professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No 304
Department of Community Medicine and Family Medicine
Third Floor
Academic Block
AIIMS Bhubaneswar
Sijua Patrapada
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9910830997 |
| Fax |
|
| Email |
cmfm_priyamadhaba@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyamadhaba Behera |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No 304
Department of Community Medicine and Family Medicine
Third Floor
Academic Block
AIIMS Bhubaneswar
Sijua Patrapada
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9910830997 |
| Fax |
|
| Email |
cmfm_priyamadhaba@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nibash K |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No 315
Resident Room
Department of Community Medicine and Family Medicine
AIIMS Bhubaneswar
Sijua Patrapada
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
7683978939 |
| Fax |
|
| Email |
nibashk30593@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS BHUBANESWAR
Sijua Patrapada
Bhubaneswar Odisha India
Pin-751019
|
|
|
Primary Sponsor
|
| Name |
Dr.Priyamadhabha Behera |
| Address |
Room 304 3rd floor academic building AIIMS Bhubaneswar Sijua Patrapada Bhubaneswar 751019
|
| 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 PRIYAMADHABA BEHERA |
AIIMS BHUBANESWAR |
ROOM NO 7 AND 57
OPD COMPLEX
DEPARTMENT OF COMMUNITY MEDICINE AND FAMILY MEDICINE
AIIMS BHUBANESWAR
SIJUA PATRAPADA
BHUBANESWAR 751019
Khordha
ORISSA |
9910830997
cmfm_priyamadhaba@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bhubaneswar |
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 |
Continuous Glucose Monitoring (CGM) |
In the intervention arm, Individuals will be provided with a continuous glucose monitoring (CGM) device for 14 days. The sensor, worn under the skin, accumulates glucose data over a specific period, and users can access this data whenever they scan the sensor. The user can view the current glucose number as well as the glucose pattern for the previous 8 hours with trend arrows, which show the direction and velocity of changing glucose levels, by scanning the sensor with the reader or smartphone
Individuals will be maintaining a chart of wake-up glucose, and peak glucose after two hours of breakfast, lunch, and dinner. The patients will receive routine standard care in addition to Continuous Glucose Monitoring (CGM).
|
| Comparator Agent |
Routine diabetic care in AIIMS Bhubaneswar NCD OPD/endocrinology OPD |
Individuals in the control group will be receiving routine standard diabetic care as per ICMR guidelines. The routine standard diabetic care will be provided in AIIMS Bhubaneswar NCD OPD/endocrinology OPD |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with type 2 diabetes on 3 or more oral antidiabetic agents with or without insulin HbA1C more than 7%. |
|
| ExclusionCriteria |
| Details |
Individuals with type 1 diabetes
Gestational diabetes mellitus
Individuals with diabetic complications (acute or chronic)
Individuals with a history of bleeding disorder
Individuals with a recent history of steroid use
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
attainment of glycemic control (HbA1c less than 7)
Mean reduction in HbA1c level
|
3months
6months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 4 |
|
Date of First Enrollment (India)
|
20/02/2024 |
| 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
|
This study is a randomized, parallel-group, two-arm controlled trial to assess the efficacy of Continuous Glucose Monitoring (CGM) in control of glycaemic status among uncontrolled type 2 diabetes patients of Khordha district, Odisha. The study will be conducted in the Non-Communicable Diseases (NCD) Prevention Clinic and Endocrinology OPD at AIIMS Bhubaneswar, a tertiary care hospital in the eastern part of India. The eligible participants will be randomized into intervention and control arm using Computer-generated random sequences, and the intervention arm will be provided with a Continuous Glucose Monitoring ( CGM) device (Abbott Freestyle Libre) for 14 days. The subcutaneous sensor will be applied on the back of the arm, along with standard treatment. The individuals in the control arm will be receiving standard antidiabetic treatment as per the guidelines. The primary outcome will be the number of individuals who attained glycaemic control and the mean reduction in the HbA1clevels after 3 months and 6 months of intervention.
|