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CTRI Number  CTRI/2024/08/072833 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 20/08/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Clinical Characteristics of Patients with Hypoglycemia Presenting to the Emergency Room 
Scientific Title of Study   Clinical profile of hypoglycaemic patients presenting in emergency room 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepak Kumar 
Designation  Assistant Professor 
Affiliation  AIIMS Patna 
Address  CGB AREA EMERGENCY MEDICINE DEPARTMENT IPD BUILDIN AIIMS PATNA

Patna
BIHAR
801507
India 
Phone  9717864257  
Fax    
Email  deepakkumar3090@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Deepak Kumar 
Designation  Assistant Professor 
Affiliation  AIIMS Patna 
Address  CGB AREA EMERGENCY MEDICINE DEPARTMENT IPD BUILDIN AIIMS PATNA

Patna
BIHAR
801507
India 
Phone  9717864257  
Fax    
Email  deepakkumar3090@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deepak Kumar 
Designation  Assistant Professor 
Affiliation  AIIMS Patna 
Address  CGB AREA EMERGENCY MEDICINE DEPARTMENT IPD BUILDIN AIIMS PATNA

Patna
BIHAR
801507
India 
Phone  9717864257  
Fax    
Email  deepakkumar3090@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Patna Bihar, India 801507 
 
Primary Sponsor  
Name  AIIMS Patna 
Address  AIIMS Patna Hospital, Phulwarisharif patna bihar, India 801507 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Deepak Kumar  AIIMS patna hospital  DGB AREA Ground Floor EMERGENCY MEDICINE DEPARTMENT IPD BUILDIN AIIMS PATNA
Patna
BIHAR 
9717864257

deepakkumar3090@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Patna RAC Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E15||Nondiabetic hypoglycemic coma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients with RBS less than 70 mg/dl on arrival to ED
2. Patients with age more than 16 years
 
 
ExclusionCriteria 
Details  Patient refusal to study  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess and evaluate the clinical profile of hypoglycemic patients presenting to ED.  6 hours to 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the incidence of hypoglycaemia in diabetic & non-diabetic patients presenting to ED.
To assess the cognitive functions using mini mental status examination (MMSE) scale after treatment.
Hypoglycaemia related morbidity & mortality as a final outcome 
6hours to 7days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   05/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  06/09/2024 
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 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  
Hypoglycemia is a leading cause of emergency department (ED) visits, particularly in patients with diabetes undergoing intensive blood glucose control. Common symptoms include sweating, dizziness, confusion, and in severe cases, loss of consciousness and seizures. While most studies focus on diabetic patients, hypoglycemia also occurs in non-diabetic individuals due to factors such as prolonged starvation, infections, and organ diseases.

The study aims to assess the clinical profile and underlying causes of hypoglycemia in both diabetic and non-diabetic patients presenting to the ED, filling a gap in current literature, especially regarding non-diabetic cases. The primary objective is to evaluate the clinical characteristics of hypoglycemic patients in the ED. Secondary objectives are to determine the incidence of hypoglycemia in diabetic vs. non-diabetic patients, assess cognitive function post-treatment, and document hypoglycemia-related morbidity and mortality.
This prospective, observational study will be conducted at AIIMS Patna over six months, involving patients aged 16 and above with a random blood sugar (RBS) level below 70 mg/dl. Data on demographics, symptoms, causes, treatment, and outcomes will be collected and analyzed. Cognitive function will be assessed using the Mini-Mental Status Examination (MMSE) after treatment.
Expected Outcomes are that this study is expected to provide insights into the clinical presentation of hypoglycemia in the ED, identify associated factors, and contribute to the knowledge base for healthcare professionals managing hypoglycemic episodes.
Prospective and observational, with a sample size of at least 100 patients, using consecutive sampling. The study will include all eligible patients with hypoglycemia during the study period.
 
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