title: Implantable insulin pump vs multiple-dose insulin for non-insulin-dependent diabetes mellitus: a randomized clinical trial. Department of Veterans Affairs Implantable Insulin Pump Study Group.
abstract: OBJECTIVE
  To determine whether implantable insulin pump (IIP) therapy and multiple daily insulin (MDI) injections could equally attain improved blood glucose control, and to compare the 2 treatments with respect to reducing daily blood glucose fluctuations, reducing serious hypoglycemic insulin reactions, and improving patients' quality of life.
  
  
  METHODS
  Randomized clinical trial.
  
  
  METHODS
  Seven Veterans Affairs medical centers.
  
  
  METHODS
  One hundred twenty-one male type II diabetic patients between the ages of 40 and 69 years, receiving at least 1 injection of insulin per day and having hemoglobin A1c (HbA1c) levels of 8% or above.
  
  
  METHODS
  Intensive therapy (IIP or MDI) for 1 year.
  
  
  METHODS
  Hemoglobin A1c and blood glucose levels.
  
  
  RESULTS
  Blood glucose levels declined to 7.96+/-1.08 mmol/L (143.4+/-19.5 mg/dL) and 8.30+/-1.52 mmol/L (149.6+/-27.4 mg/dL) (mean +/- SD) for IIP and MDI, respectively (P=.57). Hemoglobin A1c levels improved in both groups (time effect P<.001), to means of 7.54%+/-0.83% (MDI) vs 7.34%+/-0.79% (IIP). IIP reduced blood glucose fluctuations compared with MDI (P<.001), and reduced the incidence of mild clinical hypoglycemia by 68% (P<.001); IIP also eliminated the weight gain associated with MDI therapy and yielded better overall quality-of-life (P=.03) and impact-of-disease subscale scores (P=.05). Adverse events included 25% of subjects with episodes of insulin underdelivery due to microprecipitates of insulin within the pump.
  
  
  CONCLUSIONS
  Intensive insulin therapy with IIP and MDI is effective in controlling non-insulin-dependent diabetes mellitus. IIP has significant advantages in reducing glycemic variability, clinical hypoglycemia, and weight gain, while improving aspects of quality of life.
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, Md 21205, USA.
authors.forename: C D
authors.initials: CD
authors.lastname: Saudek
authors.forename: W C
authors.initials: WC
authors.lastname: Duckworth
authors.forename: A
authors.initials: A
authors.lastname: Giobbie-Hurder
authors.forename: W G
authors.initials: WG
authors.lastname: Henderson
authors.forename: R R
authors.initials: RR
authors.lastname: Henry
authors.forename: D E
authors.initials: DE
authors.lastname: Kelley
authors.forename: S V
authors.initials: SV
authors.lastname: Edelman
authors.forename: F J
authors.initials: FJ
authors.lastname: Zieve
authors.forename: R A
authors.initials: RA
authors.lastname: Adler
authors.forename: J W
authors.initials: JW
authors.lastname: Anderson
authors.forename: R J
authors.initials: RJ
authors.lastname: Anderson
authors.forename: B P
authors.initials: BP
authors.lastname: Hamilton
authors.forename: T W
authors.initials: TW
authors.lastname: Donner
authors.forename: M S
authors.initials: MS
authors.lastname: Kirkman
authors.forename: N A
authors.initials: NA
authors.lastname: Morgan
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia; D015918:Infusion Pumps, Implantable; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D015430:Weight Gain
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007328:Insulin