Observational Study of NovoPen® 4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus
Completed
- Conditions
- Diabetes Mellitus, Type 2Delivery SystemsDiabetesDiabetes Mellitus, Type 1
- Interventions
- Device: NovoPen® 4
- Registration Number
- NCT00806858
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in Asia. The aim of this observational study is to evaluate subjects' treatment satisfaction and to evaluate subjects' preference of pen device and the incidence of clinical technical complains while using NovoPen® 4 under normal clinical practice conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 526
Inclusion Criteria
- Any subject with Type 1 or Type 2 diabetes and accepting to use NovoPen® 4. The selection will be at the discretion of the individual physician.
- A study specific signed informed consent must be signed by each subject before any study-related activities or information is collected, if required by local regulations
Exclusion Criteria
- Subjects who are unlikely to comply with the protocol, e.g., unwillingness to cooperate, inability to return for the final visit
- Subjects with known or suspected allergy to any insulin or any of its excipients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A NovoPen® 4 -
- Primary Outcome Measures
Name Time Method The change in subjects' satisfaction with insulin therapy, measured by change from visit 1 to visit 2 in subject treatment satisfaction scores on the DTSQ (Diabetes Treatment Satisfaction Questionnaire) 3 months
- Secondary Outcome Measures
Name Time Method Subjects' device preference 3 months Subjects' NovoPen® 4 evaluation 3 months Number of clinical technical complaints 3 months
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇨🇳Beijing, Beijing, China