title: Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study.
abstract: OBJECTIVE
  To compare the improvements in glycemic control associated with transitioning to insulin pump therapy in patients using continuous glucose monitoring versus standard blood glucose self-monitoring.
  
  
  METHODS
  The RealTrend study was a 6-month, randomized, parallel-group, two-arm, open-label study of 132 adults and children with uncontrolled type 1 diabetes (A1C >or=8%) being treated with multiple daily injections. One group was fitted with the Medtronic MiniMed Paradigm REAL-Time system (PRT group), an insulin pump with integrated continuous subcutaneous glucose monitoring (CGM) capability, with instructions to wear CGM sensors at least 70% of the time. Conventional insulin pump therapy was initiated in the other group (continuous subcutaneous insulin infusion [CSII] group). Outcome measures included A1C and glycemic variability.
  
  
  RESULTS
  A total of 115 patients completed the study. Between baseline and trial end, A1C improved significantly in both groups (PRT group -0.81 +/- 1.09%, P < 0.001; CSII group -0.57 +/- 0.94%, P < 0.001), with no significant difference between groups. When the 91 patients who were fully protocol-compliant (including CGM sensor wear >or=70% of the time) were considered, A1C improvement was significantly greater in the PRT group (P = 0.004) (PRT group -0.96 +/- 0.93%, P < 0.001; CSII group -0.55 +/- 0.93%, P < 0.001). Hyperglycemia parameters decreased in line with improvements in A1C with no impact on hypoglycemia.
  
  
  CONCLUSIONS
  CGM-enabled insulin pump therapy improves glycemia more than conventional pump therapy during the first 6 months of pump use in patients who wear CGM sensors at least 70% of the time.
authors.affiliation: University Hospital Sainte Marguerite, Marseille, France. denis.raccah@mail.ap-hm.fr
authors.forename: Denis
authors.initials: D
authors.lastname: Raccah
authors.forename: Véronique
authors.initials: V
authors.lastname: Sulmont
authors.forename: Yves
authors.initials: Y
authors.lastname: Reznik
authors.forename: Bruno
authors.initials: B
authors.lastname: Guerci
authors.forename: Eric
authors.initials: E
authors.lastname: Renard
authors.forename: Hélène
authors.initials: H
authors.lastname: Hanaire
authors.forename: Nathalie
authors.initials: N
authors.lastname: Jeandidier
authors.forename: Marc
authors.initials: M
authors.lastname: Nicolino
mesh_terms: D000293:Adolescent; D000328:Adult; D017668:Age of Onset; D001786:Blood Glucose / Q000032:analysis / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring / Q000379:methods; D015992:Body Mass Index; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage / Q000627:therapeutic use; D007332:Insulin Infusion Systems; D008297:Male; D018670:Monitoring, Ambulatory / Q000379:methods*
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin