PMID- 21732797
OWN - NLM
STAT- MEDLINE
DCOM- 20130708
LR  - 20221207
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Print)
IS  - 1520-9156 (Linking)
VI  - 13
IP  - 10
DP  - 2011 Oct
TI  - Comparison of a novel insulin bolus-patch with pen/syringe injection to deliver 
      mealtime insulin for efficacy, preference, and quality of life in adults with 
      diabetes: a randomized, crossover, multicenter study.
PG  - 1031-7
LID - 10.1089/dia.2011.0047 [doi]
AB  - OBJECTIVE: This study compared the efficacy, safety, device satisfaction, and 
      quality of life (QOL) in people with diabetes using an insulin bolus-patch versus 
      current devices (pen/syringe) to deliver mealtime insulin. RESEARCH DESIGN AND 
      METHODS: Thirty-eight subjects with diabetes (26 with type 1 and 12 with type 2) 
      were randomized to bolus-patch or current injection device (55% pen and 45% 
      syringe) to deliver mealtime insulin in a multicenter, 6-week crossover study. 
      Efficacy was assessed by equivalence in mean daily seven-point blood glucose 
      (MDBG). Safety assessments included severe hypoglycemia episodes, adverse device 
      effects (ADEs), and adverse events (AEs). Device satisfaction was determined by 
      the validated Insulin Delivery System Rating Questionnaire (IDSRQ) and QOL by the 
      validated Diabetes Specific QOL Scale (DSQOLS). RESULTS: Using bolus-patch, MDBG 
      (mean+/-SE) was equivalent to that using pen/syringe (8.61+/-0.28 vs. 
      9.02+/-0.26 mmol/L; P=0.098). SD of the seven-point blood glucose measurements was 
      lower using bolus-patch (3.18+/-0.18 vs. 3.63+/-0.17 mmol/L; P=0.004), as was the 
      coefficient of variation (CV) (37.2+/-1.7 vs. 40.3+/-1.7%; P=0.046). Hemoglobin A1c, 
      1,5-anhydroglucitol, fructosamine, and insulin use were similar between groups. 
      There were no severe hypoglycemia episodes or serious ADEs. Between-device AEs 
      were comparable. Subjects scored better on six of seven subscales on the DSQOLS 
      and five of six subscales on the IDSRQ while using bolus-patch versus 
      pen/syringe. At study completion, 76% of subjects would choose to switch to 
      bolus-patch (P=0.001). CONCLUSIONS: Delivery of mealtime insulin with bolus-patch 
      compared with pen/syringe resulted in equivalent MDBG, lower SD and CV of 
      seven-point blood glucose measurements, good safety, significant device 
      satisfaction, and improved QOL.
FAU - Bohannon, Nancy
AU  - Bohannon N
AD  - Monteagle Medical Center, San Francisco, California 94110-4415, USA. 
      sugarnancy@pol.net
FAU - Bergenstal, Richard
AU  - Bergenstal R
FAU - Cuddihy, Robert
AU  - Cuddihy R
FAU - Kruger, Davida
AU  - Kruger D
FAU - List, Susan
AU  - List S
FAU - Massaro, Elaine
AU  - Massaro E
FAU - Molitch, Mark
AU  - Molitch M
FAU - Raskin, Philip
AU  - Raskin P
FAU - Remtema, Heather
AU  - Remtema H
FAU - Strowig, Suzanne
AU  - Strowig S
FAU - Whitehouse, Fred
AU  - Whitehouse F
FAU - Brunelle, Rocco L
AU  - Brunelle RL
FAU - Dreon, Darlene
AU  - Dreon D
FAU - Tan, Meng
AU  - Tan M
LA  - eng
SI  - ClinicalTrials.gov/NCT01073566
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110706
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Blood Glucose/metabolism
MH  - Cross-Over Studies
MH  - Diabetes Mellitus/blood/*drug therapy
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage
MH  - Injections, Subcutaneous
MH  - Insulin/*administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Quality of Life
MH  - Transdermal Patch
MH  - Young Adult
PMC - PMC4346544
EDAT- 2011/07/08 06:00
MHDA- 2013/07/09 06:00
PMCR- 2012/10/01
CRDT- 2011/07/08 06:00
PHST- 2011/07/08 06:00 [entrez]
PHST- 2011/07/08 06:00 [pubmed]
PHST- 2013/07/09 06:00 [medline]
PHST- 2012/10/01 00:00 [pmc-release]
AID - 10.1089/dia.2011.0047 [pii]
AID - 10.1089/dia.2011.0047 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2011 Oct;13(10):1031-7. doi: 10.1089/dia.2011.0047. Epub 
      2011 Jul 6.