Behavior Analysis of Users in Diabetes and Weight Management Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •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.
- •Participants who can read, understand, and follow the Instructions for Use (IFU), study questionnaires (SUS, NASA, TLX, UEQ-S), and observer instructions.
- •Participants who are willing to provide written informed consent and comply with all study procedures, including simulated-use tasks and debrief interviews.
排除标准
- •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.
- •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.
- •Cognitive impairment, memory disorder, or psychiatric condition that may affect the ability to follow instructions, provide informed consent, or perform procedural steps reliably.
- •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.
- •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.
- •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.
- •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).
- •Any condition judged by the Investigator to interfere with participation, compromise data quality, or pose a risk to the participant or study personnel.
- •Individuals who refuse or are unable to provide written informed consent.
研究者
Dr Prasad G M
Pranav Diabetes Center