title: 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.
abstract: 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.
  
  
  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.
authors: Monteagle Medical Center, San Francisco, California 94110-4415, USA. sugarnancy@pol.net
authors: Nancy
authors: N
authors: Bohannon
authors: Richard
authors: R
authors: Bergenstal
authors: Robert
authors: R
authors: Cuddihy
authors: Davida
authors: D
authors: Kruger
authors: Susan
authors: S
authors: List
authors: Elaine
authors: E
authors: Massaro
authors: Mark
authors: M
authors: Molitch
authors: Philip
authors: P
authors: Raskin
authors: Heather
authors: H
authors: Remtema
authors: Suzanne
authors: S
authors: Strowig
authors: Fred
authors: F
authors: Whitehouse
authors: Rocco L
authors: RL
authors: Brunelle
authors: Darlene
authors: D
authors: Dreon
authors: Meng
authors: M
authors: Tan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D018592:Cross-Over Studies; D003920:Diabetes Mellitus / Q000097:blood / Q000188:drug therapy*; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D057968:Transdermal Patch; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin