A Multicenter, Prospective, Observational, Open-Label Study of the Safety and Comfort of Gensulin® Delivery Device Use in a Large Cohort of Adult and Elderly Patients with Type 2 Diabetes
Abstract
:1. Introduction
2. Materials and Methods
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Complaint | Number of Patients n = 258 (2.5%) |
---|---|
The insulin injection was too fast or too slow | 2.3% |
The set dose was higher than intended | 0.7% |
The wrong dose was delivered | 2.1% |
The patient did not know the insulin injection technique | 44% |
Difficult to operate | 0.04% |
Pen got stuck | 0.04% |
Needles were getting broken | 0.16% |
Too heavy | 0.08% |
Too small | 0.04% |
Too lose in setting the dose | 0.08% |
Leaky case | 0.19% |
The number on the scale too small to read | 0.08% |
Numbers on the scale clashed | 2.8% |
Broken case | 0.4% |
Broken spring | 0.2% |
Problems with correcting the dose | 0.2% |
Cartridge too small | 0.04% |
Left marks on the skin | 0.04% |
The sheath did not open properly | 0.04% |
Question Rate | Very Good | Good | Sufficient | Poor | Very Poor |
---|---|---|---|---|---|
Setting and correcting the dose | 87.8% | 10.0% | 1.7% | 0.3% | 0.2% |
Information confirming that the dose was administrated successfully | 92.0% | 4.7% | 1.3% | 0.6% | 1.4% |
Trigger location | 80.9% | 11.6% | 2.2% | 2.0% | 3.3% |
Force needed to insulin administration | 75.0% | 17.2% | 3.1% | 2.1% | 2.6% |
Question Rate | Better | The Same | Worse |
---|---|---|---|
Setting and correcting the dose | 34.1% | 56.5% | 9.4% |
Information confirming that the dose was administrated correctly | 79.8% | 12.7% | 7.5% |
Trigger location | 26.3% | 27.2% | 46.5% |
Force needed to insulin administration | 50.0% | 32.7% | 17.3% |
Adverse Event | Number of Patients n = 65 (0.6%) |
---|---|
Headache | 3.2% |
Tremor | 17.7% |
Difficulty breathing | 4.8% |
Tingle of hands and feet | 4.8% |
Weakness | 9.7% |
Swelling | 1.6% |
Sweating | 14.5% |
Somnolence | 1.6% |
High blood pressure | 1.6% |
Feeling bad | 4.8% |
Dizziness | 8.1% |
Fingernails changed color | 1.6% |
Palpitation | 1.6% |
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Masierek, M.; Nabrdalik, K.; Kwiendacz, H.; Sawczyn, T.; Gumprecht, J. A Multicenter, Prospective, Observational, Open-Label Study of the Safety and Comfort of Gensulin® Delivery Device Use in a Large Cohort of Adult and Elderly Patients with Type 2 Diabetes. Int. J. Environ. Res. Public Health 2020, 17, 7587. https://doi.org/10.3390/ijerph17207587
Masierek M, Nabrdalik K, Kwiendacz H, Sawczyn T, Gumprecht J. A Multicenter, Prospective, Observational, Open-Label Study of the Safety and Comfort of Gensulin® Delivery Device Use in a Large Cohort of Adult and Elderly Patients with Type 2 Diabetes. International Journal of Environmental Research and Public Health. 2020; 17(20):7587. https://doi.org/10.3390/ijerph17207587
Chicago/Turabian StyleMasierek, Małgorzata, Katarzyna Nabrdalik, Hanna Kwiendacz, Tomasz Sawczyn, and Janusz Gumprecht. 2020. "A Multicenter, Prospective, Observational, Open-Label Study of the Safety and Comfort of Gensulin® Delivery Device Use in a Large Cohort of Adult and Elderly Patients with Type 2 Diabetes" International Journal of Environmental Research and Public Health 17, no. 20: 7587. https://doi.org/10.3390/ijerph17207587