PMID- 21988614
OWN - NLM
STAT- MEDLINE
DCOM- 20120321
LR  - 20221207
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 27
IP  - 12
DP  - 2011 Dec
TI  - Preference for a new prefilled insulin pen compared with the original pen.
PG  - 2323-33
LID - 10.1185/03007995.2011.630721 [doi]
AB  - BACKGROUND: The prevalence of diabetes is increasing in the United States and 
      worldwide. Insulin injection pens are preferred over vial/syringe methods, and 
      are designed to facilitate use, improve adherence, and provide accurate insulin 
      delivery. OBJECTIVE: This study compares the efficacy, safety profile, and 
      patient preference of the new prefilled insulin pen FT* versus the original 
      insulin pen FP. METHODS: This randomized, multicenter, open-label, crossover 
      study was conducted in insulin-treated pen-naive patients with type 1 or type 2 
      diabetes mellitus (n = 242, mean age 58 years, mean body mass index (BMI) 
      31.4 kg/m(2), baseline glycosylated hemoglobin [HbA(1c)] 7.3%). Patients were 
      randomized 1:1 to either FT or FP for 12 weeks and then switched to the alternate 
      insulin device for 12 weeks, while the insulin regimen was kept the same. All 
      subjects were on either insulin detemir alone or in combination with insulin 
      aspart treatment during the trial. HbA(1c) was assessed at screening, 
      randomization, cross-over period, and end of trial. The safety profile was 
      evaluated based on adverse events (AEs), adverse device effects (ADEs), and 
      hypoglycemic episodes. Patient-reported outcome (PRO) questionnaires assessed at 
      randomization, crossover period, and end of trial were used to investigate the 
      subjects' preference of the two prefilled devices. RESULTS: A total of 400 
      subjects were screened, 242 subjects were randomized and exposed to the prefilled 
      pen devices, and 222 subjects completed the trial. Twenty subjects discontinued 
      the study. Four subjects discontinued due to adverse events. Subject default 
      (withdrawal of consent and loss to follow up) was the most common reason for 
      discontinuation (10 subjects), Glycemic control achieved with FT was comparable 
      to that with FP (FT-FP: difference -0.047 [95% CI -0.127; 0.032%]). The majority 
      of subjects (68%) indicated a preference for the FT device over FP. In addition, 
      the majority of subjects found FT easier to use (64% [144/226]), easier to inject 
      the insulin dose (65% [148/227]) and easier to push for injection (69% 
      [155/226]). The Treatment Related Impact Measure-Diabetes (TRIM-D) ratings of FT 
      were significantly higher for diabetes management facilitation (P < 0.001), and 
      treatment burden (P < 0.001). The safety profiles were comparable for FT and FP. 
      CONCLUSIONS: FT was found to be comparable to FP with respect to the efficacy and 
      safety profile. Significantly more subjects favored the FT device in terms of 
      ease of use, insulin injection, diabetes management, and overall preference. A 
      limitation of the present study was its open-label design because the pen devices 
      used to administer the insulin were distinctively different and the use of a 
      double-dummy design was precluded by the absence of placebo pen devices. The 
      questionnaires about treatment were related to the use of the device and 
      therefore a blinded study was not possible.
FAU - Garg, S
AU  - Garg S
AD  - Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, 
      Aurora, CO 80045, USA. satish.garg@ucdenver.edu
FAU - Bailey, T
AU  - Bailey T
FAU - DeLuzio, T
AU  - DeLuzio T
FAU - Pollom, D
AU  - Pollom D
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20111031
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (hemoglobin A1c protein, human)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Cross-Sectional Studies
MH  - Diabetes Mellitus, Type 1/blood/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemia/blood/chemically induced
MH  - Hypoglycemic Agents/*administration & dosage/adverse effects
MH  - Injections, Intradermal/adverse effects/instrumentation/methods
MH  - Insulin/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Patient Compliance
MH  - Surveys and Questionnaires
EDAT- 2011/10/13 06:00
MHDA- 2012/03/22 06:00
CRDT- 2011/10/13 06:00
PHST- 2011/10/13 06:00 [entrez]
PHST- 2011/10/13 06:00 [pubmed]
PHST- 2012/03/22 06:00 [medline]
AID - 10.1185/03007995.2011.630721 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2011 Dec;27(12):2323-33. doi: 10.1185/03007995.2011.630721. 
      Epub 2011 Oct 31.