None listed
Conditions
Interventions
Intervention1: 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
Sponsors
Dr. Reddy s Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint of this study is Overall Use-Success Rate, defined as all critical tasks completed correctly without unmitigated critical errors.Timepoint: Immediately after completion of Simulated use tasks for each device | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: After completion of each simulated device use session | — |
Countries
India
Contacts
Public ContactMeena Dalal
Pranav Diabetes Center
Outcome results
None listed