PMID- 22775367
OWN - NLM
STAT- MEDLINE
DCOM- 20130212
LR  - 20151119
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Linking)
VI  - 14
IP  - 10
DP  - 2012 Oct
TI  - Evaluation of a new reusable insulin pen (ClikSTAR) in Canadian patients with 
      type 1 and type 2 diabetes mellitus receiving insulin glargine.
PG  - 926-35
AB  - BACKGROUND: The objective of this Canadian observational study was to assess the 
      safety and patient satisfaction with the ClikSTAR((R)) (sanofi-aventis, Frankfurt 
      am Main, Germany) reusable insulin pen in clinical practice. SUBJECTS AND 
      METHODS: Patients with diabetes (n=2,517) were recruited from 103 sites, provided 
      with the ClikSTAR pen, and instructed to report product technical complaints 
      (PTCs), product technical failures (PTFs), and adverse events (AEs) over 6-12 
      weeks of use. A patient subgroup (n = 301) completed a pen use questionnaire at 
      12 weeks. The risk acceptance criterion was that no validated PTF led to a 
      serious AE (SAE). PTFs were PTCs having a confirmed technical deficiency. 
      RESULTS: Patients (68.5% with type 2 diabetes) had a mean age of 56.2 years, and 
      92.5% were insulin pen users. In total, 84 PTCs were reported by 79 (3.1%) 
      patients. Most PTCs were due to pen handling errors. PTCs from 12 patients were 
      possibly related to AEs, three of which were SAEs; none was confirmed to be due 
      to a PTF. The single reported PTF was not related to an AE/SAE. In the substudy, 
      97.0% and 95.3% of patients rated "ease of learning" and "ease of use" of the 
      ClikSTAR pen as excellent or good, respectively. Mean scores for patient 
      satisfaction, convenience, flexibility, and recommendations of current treatment 
      on the Diabetes Treatment Satisfaction Questionnaire (change version) had 
      positive changes ranging from 1.0 to 1.8. CONCLUSIONS: With ClikSTAR, PTCs were 
      infrequent, and there were no PTFs associated with AEs, demonstrating that the 
      pen is reliable and safe with high levels of patient acceptance and satisfaction.
FAU - Gottesman, Irving
AU  - Gottesman I
AD  - University of Toronto, Mississauga, Ontario, Canada. irvgottesman@hotmail.com
FAU - Perron, Patrice
AU  - Perron P
FAU - Berard, Lori
AU  - Berard L
FAU - Stewart, John
AU  - Stewart J
FAU - Basso, Nils
AU  - Basso N
FAU - Mettimano, Kim
AU  - Mettimano K
FAU - Elliott, Thomas
AU  - Elliott T
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20120709
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin, Long-Acting)
RN  - 2ZM8CX04RZ (Insulin Glargine)
SB  - IM
MH  - Canada/epidemiology
MH  - Diabetes Mellitus, Type 1/*drug therapy/epidemiology
MH  - Diabetes Mellitus, Type 2/*drug therapy/epidemiology
MH  - Drug Delivery Systems/*instrumentation
MH  - Equipment Design
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage
MH  - Injections, Subcutaneous/instrumentation
MH  - Insulin Glargine
MH  - Insulin, Long-Acting/*administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction/*statistics & numerical data
MH  - Prospective Studies
MH  - Surveys and Questionnaires
EDAT- 2012/07/11 06:00
MHDA- 2013/02/13 06:00
CRDT- 2012/07/11 06:00
PHST- 2012/07/11 06:00 [entrez]
PHST- 2012/07/11 06:00 [pubmed]
PHST- 2013/02/13 06:00 [medline]
AID - 10.1089/dia.2012.0067 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2012 Oct;14(10):926-35. doi: 10.1089/dia.2012.0067. Epub 
      2012 Jul 9.