| CTRI Number |
CTRI/2024/12/078445 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
STUDY ON REDUCING HYPOGLYCEMIA IN HEMODIALYSIS PATIENTS USING CGM AND ITS IMPACT ON COGNITIVE FUNCTION AND CARDIOVASCULAR EVENTS |
|
Scientific Title of Study
|
MITIGATING HYPOGLYCEMIA RISKS IN HEMODIALYSIS PATIENTS USING CONTINOUS GLUCOSE MONITORING AND ITS IMPACT ON COGNITIVE FUNCTION,INTRADIALYTIC COMPLICATIONS AND CARDIOVASCULAR EVENTS |
| 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 NANDA KAMAL |
| Designation |
PG RESIDENT |
| Affiliation |
BELIEVERS CHURCH MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL MEDICINE
BELIEVERS CHURCH MEDICAL COLLEGE
KUTTAPUZHA
THIRUVALLA
Pathanamthitta
KERALA
689103
India |
| Phone |
9497854565 |
| Fax |
|
| Email |
nandakamal0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUNIL ANTONY |
| Designation |
PROFESSOR |
| Affiliation |
BELIEVERS CHURCH MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL MEDICINE
BELIEVERS CHURCH MEDICAL COLLEGE
KUTTAPUZHA
THIRUVALLA
Pathanamthitta
KERALA
689103
India |
| Phone |
9497854565 |
| Fax |
|
| Email |
drsunilantony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUNIL ANTONY |
| Designation |
PROFESSOR |
| Affiliation |
BELIEVERS CHURCH MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL MEDICINE
BELIEVERS CHURCH MEDICAL COLLEGE
KUTTAPUZHA
THIRUVALLA
Pathanamthitta
KERALA
689103
India |
| Phone |
9497854565 |
| Fax |
|
| Email |
drsunilantony@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF GENERAL MEDICINE
BELIEVERS CHURCH MEDICAL COLLEGE,THIRUVALLA |
|
|
Primary Sponsor
|
| Name |
DR JENCY MARIA KOSHY |
| Address |
DEPARTMENT OF GENERAL MEDICINE
BELIEVERS CHURCH MEDICAL COLLEGE,KUTTAPUZHA,THIRUVALLA,689103 |
| Type of Sponsor |
Other [OTHERS -DEPARTMENT FUND] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DEPARTMENT OF NEPHROLOGYBELIEVERS CHURCH MEDICAL COLLEGE |
BELIEVERS CHURCH MEDICAL COLLEGE,KUTTAPUZHA,THIRUVALLA,689103 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR NANDA KAMAL |
BELIEVERS CHURCH MEDICAL COLLEGE |
DEPARTMENT OF NEPHROLOGY
BELIEVERS CHURCH MEDICAL COLLEGE,KUTTAPUZHA,THIRUVALLA,689103
Pathanamthitta
KERALA |
9497854565
nandakamal0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DEPARTMENT OF GENERAL MEDICINE,INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CONTINOUS GLUCOSE MONITORING |
HEMODIALYSIS PATIENTS WHO ARE DIABETIC AND ON INSULIN AND PATIENT IS FOLLOWED UP FOR 1 YEAR |
| Comparator Agent |
HEMODIALYSIS PATIENTS |
HEMODIALYSIS PATIENTS WHO ARE DIABETIC |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
PATIENT WITH DIABETIC NEPHROPATHY ON HEMODIALYSIS WITH MINIMUM TWICE DIALYSIS WEEKLY |
|
| ExclusionCriteria |
| Details |
PATIENT TAKING STEROIDS
PATIENT WITH PRE EXISTING PSYCHIATRIC ILLNESS |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO REDUCE THE RISK OF HYPOGLYCEMIA IN HEMODIALYSIS PATIENTS USING CGM |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EVALUATE THE FREQUENCY,SEVERITY AND PATTERN OF HYPOGLYCEMIC EPISODES IN DIALYSIS PATIENTS THROUGH CGM DATA AND APPROPRIATE INTERVENTIONS IF ANY |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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 Applicable |
| 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 IS A STUDY TO REDUCE THE RISK OF HYPOGLYCEMIA IN HEMODIALYSIS PATIENTS USING CGM AND TO ASSESS ITS IMPACT ON COGNITIVE DECLINE AND CARDIAC COMPLICATIONS.THIS STUDY WILL HELP TO REDUCE THE EPISODES OF HYPOGLYCEMIA IN PATIENTS DURING HEMODIALYSIS.THIS STUDY IS TO BE DONE IN DIABETIC NEPHROPATHY PATIENTS WHO ARE ATLEAST TWICE WEEKLY ON HEMODIALYSIS |