title: The Impact of Insulin Pump Therapy on Glycemic Profiles in Patients with Type 2 Diabetes: Data from the OpT2mise Study.
abstract: BACKGROUND
  The OpT2mise randomized trial was designed to compare the effects of continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI) on glucose profiles in patients with type 2 diabetes.
  
  
  METHODS
  Patients with glycated hemoglobin (HbA1c) levels of ≥8% (64 mmol/mol) and ≤12% (108 mmol/mol) despite insulin doses of 0.7-1.8 U/kg/day via MDI were randomized to CSII (n=168) or continued MDI (n=163). Changes in glucose profiles were evaluated using continuous glucose monitoring data collected over 6-day periods before and 6 months after randomization.
  
  
  RESULTS
  After 6 months, reductions in HbA1c levels were significantly greater with CSII (-1.1±1.2% [-12.0±13.1 mmol/mol]) than with MDI (-0.4±1.1% [-4.4±12.0 mmol/mol]) (P<0.001). Similarly, compared with patients receiving MDI, those receiving CSII showed significantly greater reductions in 24-h mean sensor glucose (SG) (treatment difference, -17.1 mg/dL; P=0.0023), less exposure to SG >180 mg/dL (-12.4%; P=0.0004) and SG >250 mg/dL (-5.5%; P=0.0153), and more time in the SG range of 70-180 mg/dL (12.3%; P=0.0002), with no differences in exposure to SG<70 mg/dL or in glucose variability. Changes in postprandial (4-h) glucose area under the curve >180 mg/dL were significantly greater with CSII than with MDI after breakfast (-775.9±1,441.2 mg/dL/min vs. -160.7±1,074.1 mg/dL/min; P=0.0015) and after dinner (-731.4±1,580.7 mg/dL/min vs. -71.1±1,083.5 mg/dL/min; P=0.0014).
  
  
  CONCLUSIONS
  In patients with suboptimally controlled type 2 diabetes, CSII significantly improves selected glucometrics, compared with MDI, without increasing the risk of hypoglycemia.
authors.affiliation: 1 Diabetes Unit, Endocrinology and Nutrition Department, University Hospital Clinic , Barcelona, Spain .
authors.forename: Ignacio
authors.initials: I
authors.lastname: Conget
authors.affiliation: 2 Medtronic Bakken Research Center , Maastricht, The Netherlands .
authors.forename: Javier
authors.initials: J
authors.lastname: Castaneda
authors.affiliation: 3 University Clinic of Endocrinology , Skopje, Macedonia .
authors.forename: Goran
authors.initials: G
authors.lastname: Petrovski
authors.affiliation: 4 CHU de Nancy , Vandoeuvre-Les-Nancy, France .
authors.forename: Bruno
authors.initials: B
authors.lastname: Guerci
authors.affiliation: 5 Medtronic International Trading Sàrl , Tolochenaz, Switzerland .
authors.forename: Anne-Sophie
authors.initials: AS
authors.lastname: Racault
authors.affiliation: 6 Department of Endocrinology, University of Caen Côte de Nacre Regional Hospital Center , Caen, France .
authors.forename: Yves
authors.initials: Y
authors.lastname: Reznik
authors.affiliation: 5 Medtronic International Trading Sàrl , Tolochenaz, Switzerland .
authors.forename: Ohad
authors.initials: O
authors.lastname: Cohen
authors.affiliation: 5 Medtronic International Trading Sàrl , Tolochenaz, Switzerland .
authors.forename: Sarah
authors.initials: S
authors.lastname: Runzis
authors.affiliation: 5 Medtronic International Trading Sàrl , Tolochenaz, Switzerland .
authors.forename: Simona
authors.initials: S
authors.lastname: de Portu
authors.affiliation: 7 LMC Diabetes & Endocrinology , Toronto, Ontario, Canada .
authors.forename: Ronnie
authors.initials: R
authors.lastname: Aronson
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring; D062408:Breakfast; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D008297:Male; D062407:Meals; D008875:Middle Aged; D019518:Postprandial Period
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human