title: Effect of Sensor-Augmented Pump Treatment Versus Multiple Daily Injections on Albuminuria: A 1-Year Randomized Study.
abstract: BACKGROUND
  The effect of glycemic control on persisting albuminuria remains unclear. Insulin delivery and glucose variability may be important.
  
  
  OBJECTIVE
  This study aimed to investigate the effect of 1-year treatment with sensor-augmented insulin pump (SAP) or multiple daily injections (MDIs) on albuminuria.
  
  
  METHODS
  This was a randomized controlled open-label parallel trial composed of 60 patients with type 1 diabetes with a history of albuminuria and on stable renin-angiotensin system inhibition, were randomly assigned to SAP or MDI. Urine albumin creatinine ratio (UACR) was measured in three urine samples at all visits. Glucose variability and glomerular filtration rate ((51)Cr-EDTA-GFR) were measured at beginning and study end. Using linear mixed model, change in UACR between groups was analyzed as intention to treat.
  
  
  METHODS
  Change in UACR was measured.
  
  
  RESULTS
  Fifty-five patients (SAP, n = 26; MDI, n = 29) completed the study. Diabetes duration (mean ± SD, 33 ± 12 y), UACR (geometric mean, 99 mg/g; interquartile range, 37-233 mg/g), (51)Cr-EDTA-GFR (94 ± 22 mL/min/1.73m(2)), glycosylated hemoglobin (HbA1c) (9.0 ± 1.1%), glucose variability (calculated as SD), 4.0 ± 1.0 mmol/l; no-group differences (P ≥ .06 for all). After 1 year, change in UACR was mean, -13%; 95% confidence interval, -39 to 22 with SAP vs mean, 30%; 95% CI, -12 to 92% on MDI treatment (unadjusted P = .051; adjusted for HbA1c, P = .04). HbA1c decreased 1.3 ± 1.0 vs 0.6 ± 1.0% (P = .013), glucose variability decreased 0.9 ± 1.1 vs 0.3 ± 1.0 mmol/L (P = .04), and (51)Cr-EDTA-GFR declined 5.6 ± 9.6 vs 3.4 ± 13 mL/min/1.73m(2) (P = .50) with SAP vs MDI treatment. There were no changes in blood pressure (P ≥ .27).
  
  
  CONCLUSIONS
  SAP treatment reduced UACR in a randomized controlled trial in type 1 diabetes patients with a history of albuminuria on stable renin-angiotensin system inhibition. Significance was reached after adjustment. SAP treatment reduced HbA1c and glucose variability (calculated as SD).
authors.affiliation: Steno Diabetes Center (S.R., T.W.H., P.R.), 2820 Gentofte, Denmark; Nordsjaellands Hospital (S.R., S.A.), 3400 Hilleroed, Denmark; Aarhus University (P.R.), 8000 Aarhus C, Denmark; and University of Copenhagen (P.R.), 2200 Copenhagen N, Denmark.
authors.forename: Signe
authors.initials: S
authors.lastname: Rosenlund
authors.affiliation: Steno Diabetes Center (S.R., T.W.H., P.R.), 2820 Gentofte, Denmark; Nordsjaellands Hospital (S.R., S.A.), 3400 Hilleroed, Denmark; Aarhus University (P.R.), 8000 Aarhus C, Denmark; and University of Copenhagen (P.R.), 2200 Copenhagen N, Denmark.
authors.forename: Tine Willum
authors.initials: TW
authors.lastname: Hansen
authors.affiliation: Steno Diabetes Center (S.R., T.W.H., P.R.), 2820 Gentofte, Denmark; Nordsjaellands Hospital (S.R., S.A.), 3400 Hilleroed, Denmark; Aarhus University (P.R.), 8000 Aarhus C, Denmark; and University of Copenhagen (P.R.), 2200 Copenhagen N, Denmark.
authors.forename: Peter
authors.initials: P
authors.lastname: Rossing
authors.affiliation: Steno Diabetes Center (S.R., T.W.H., P.R.), 2820 Gentofte, Denmark; Nordsjaellands Hospital (S.R., S.A.), 3400 Hilleroed, Denmark; Aarhus University (P.R.), 8000 Aarhus C, Denmark; and University of Copenhagen (P.R.), 2200 Copenhagen N, Denmark.
authors.forename: Steen
authors.initials: S
authors.lastname: Andersen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000419:Albuminuria / Q000188:drug therapy*; D015374:Biosensing Techniques; D001786:Blood Glucose / Q000378:metabolism; D001794:Blood Pressure; D003404:Creatinine / Q000652:urine; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy / Q000652:urine; D005260:Female; D005919:Glomerular Filtration Rate; D006442:Glycated Hemoglobin / Q000032:analysis / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D003404:Creatinine; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin