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CTRI Number  CTRI/2025/12/099587 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 19/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Human Factors- Usability Validation Study 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Study to Understand How Participants Use Injection Pens for Diabetes and Weight Management. 
Scientific Title of Study   Behavior Analysis of Users in Diabetes and Weight Management Therapy 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
TG/PRO/25/MD/008 Version 1.0 Dated 04DEC2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prasad G M  
Designation  Principal Investigator  
Affiliation  Pranav Diabetes Center 
Address  57/1, Nanda Complex, Ramamurthy Nagar Main Road, Banaswadi, Bengaluru-560043
-
Bangalore
KARNATAKA
560043
India 
Phone  9731911630  
Fax  -  
Email  drgmprasad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prasad G M  
Designation  Principal Investigator  
Affiliation  Pranav Diabetes Center 
Address  57/1, Nanda Complex, Ramamurthy Nagar Main Road, Banaswadi, Bengaluru-560043
-
Bangalore
KARNATAKA
560043
India 
Phone  9731911630  
Fax  -  
Email  drgmprasad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Meena Dalal 
Designation  CEO and Founder  
Affiliation  TrialGuna Private Limited 
Address  467, 1st Main, 4th Cross, Royal County Layout, JP Nagar, 8th Phase, 2nd Block, Bangalore, Karnataka-560083, India
-
Bangalore
KARNATAKA
560083
India 
Phone  9972636265  
Fax  -  
Email  meena@trialguna.com  
 
Source of Monetary or Material Support  
Dr. Reddy’s Laboratories Limited, #7-1-27, Ameerpet, Hyderabad – 500 016, Telangana, India 
 
Primary Sponsor  
Name  Dr. Reddy’s Laboratories Limited 
Address  #7-1-27, Ameerpet, Hyderabad – 500 016, Telangana, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Prasad G M   Pranav Diabetes Center  OPD room, ground floor, Department of Diabetology, 57/1, Nanda Complex, Ramamurthy Nagar Main Road, Banaswadi, Bengaluru-560043
Bangalore
KARNATAKA 		 9731911630
-
drgmprasad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pranav Diabetes Center Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participants with Diabetes Mellitus 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. DRL Device A Pen Injector 2. DRL Device B Pen Injector   Simulated use of DRL Device A and DRL Device B pen injectors for subcutaneous administration using prefilled cartridges used as intervention.  
Comparator Agent  FlexTouch Pen injector  Simulated use of the available FlexTouch pen injector using prefilled cartridges, under identical simulated-use conditions. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Adults aged greater than equal to 18 years, including representation across two age groups:
18 to less than 50 years and greater than equal to 50 years.
2) Intended device users, including:
o Patients who would typically self-administer GLP-1 or insulin pen injections
o Caregivers responsible for assisting in pen-based injections
o Health Care workers (HCWs) such as nurses or physicians who may teach, demonstrate, or supervise pen injection
techniques
o Novice users with no prior training or experience on the FlexTouch pen (preferred worst-case scenario)
o Users experienced with other mechanical/insulin pen platforms (e.g., Solostar, KwikPen, Insu-Pen)
o Users with moderate familiarity with pen injectors, including caregivers and HCPs
o Ambidextrous users, or users with varied hand dominance, to capture ergonomic diversity
3) Male or female participants willing and able to perform all simulated-use procedures associated with the study.
4) Participants who can read, understand, and follow the Instructions for Use (IFU), study questionnaires (SUS, NASA, TLX, UEQ-S), and observer instructions.
5) Participants who are willing to provide written informed consent and comply with all study procedures, including simulated-use tasks and debrief interviews. 
 
ExclusionCriteria 
Details  1) Severe visual impairment that cannot be adequately corrected with glasses or contact lenses, and which may interfere
with reading the IFU, viewing the dose window, or performing device tasks.
2) Significant motor or dexterity limitations (e.g., tremors, severe arthritis, paralysis, recent upper-limb injury) that would
prevent safe handling of a pen injector during simulated use.
3) Cognitive impairment, memory disorder, or psychiatric condition that may affect the ability to follow instructions,
provide informed consent, or perform procedural steps reliably.
4) Prior specialized or intensive training on the DRL Device A/B pen or participation in device-specific formative HF
sessions that could introduce user bias.
5) Participation in another human factors, usability, or clinical investigation involving pen injectors or injection devices
within the last 30 days, which may influence user behavior or learning effects.
6) Inability to understand or communicate in the study language sufficiently to follow the IFU, complete questionnaires
(SUS, NASA-TLX, UEQ-S), or participate in interviews.
7) Medical or neurological conditions that may impair task performance or present safety concerns during simulated-use
activities (e.g., uncontrolled seizures, severe neuropathy preventing grip strength).
8) Any condition judged by the Investigator to interfere with participation, compromise data quality, or pose a risk to the
participant or study personnel.
9) Individuals who refuse or are unable to provide written informed consent.  
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary endpoint of this study is Overall Use-Success Rate, defined as all critical tasks completed correctly without
unmitigated critical errors. 		 Immediately after completion of Simulated use tasks for each device  
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare Risk-Weighted Error Scores (RWES) for DRL Device A vs FlexTouch Pen and DRL Device
B vs FlexTouch Pen.
2. To compare perceived usability via System Usability Scale (SUS) scores for DRL Device A vs FlexTouch
Pen and DRL Device B vs FlexTouch Pen.
3. To compare cognitive workload via NASA-TLX (Short) scores for DRL Device A vs FlexTouch Pen and
DRL Device B vs FlexTouch Pen.
4. To compare user experience via UEQ-S (Pragmatic Quality, Hedonic Quality and Overall UEQ-S scores)
for DRL Device A vs FlexTouch Pen and DRL Device B vs FlexTouch Pen.
5. Assess trust, confidence, preference, and ease-of-use based on post-task questionnaires.  		 After completion of each simulated device use session 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   08/01/2026 
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="1"
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 study is a comparative, simulated use, controlled Human Factors Summative Study designed to evaluate the usability of injection pen devices intended for diabetes and weight management. Adult participants, including patients, caregivers, and healthcare professionals, will be enrolled after providing informed consent. Each participant will be randomly assigned to use both the investigational pen injector(s) and a commercially available comparator pen injector in a crossover manner. The study will be conducted in a simulated home-use environment. No actual medication will be administered during the study. Prefilled cartridges and injection pads will be used to simulate the injection process. Participants will perform predefined critical tasks related to pen injector use according to the Instructions for use. Task performance, use errors, and user behavior will be observed and recorded. Usability, workload, and user experience will be assessed using validated questionnaires immediately after device use. The results of this study will help assess ease of use, identify potential use errors, and support safe introduction of the pen injector devices for diabetes and weight management.

 
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