title: HbA1c After a Short Period of Monotherapy With Metformin Identifies Durable Glycemic Control Among Adolescents With Type 2 Diabetes.
abstract: OBJECTIVE
  To determine whether clinically accessible parameters early in the course of youth-onset type 2 diabetes predict likelihood of durable control on oral therapy.
  
  
  METHODS
  TODAY was a randomized clinical trial of adolescents with type 2 diabetes. Two groups, including participants from all three treatments, were defined for analysis: (1) those who remained in glycemic control for at least 48 months of follow-up and (2) those who lost glycemic control before 48 months. Outcome group was analyzed in univariate and multivariate models as a function of baseline characteristics (age, sex, race/ethnicity, socioeconomic status, BMI, waist circumference, Tanner stage, disease duration, depressive symptoms) and biochemical measures (HbA1c, C-peptide, lean and fat body mass, insulin inverse, insulinogenic index). Receiver operating characteristic curves were used to analyze HbA1c cut points.
  
  
  RESULTS
  In multivariate models including factors significant in univariate analysis, only HbA1c and insulinogenic index at randomization remained significant (P < 0.0001 and P = 0.0002, respectively). An HbA1c cutoff of 6.3% (45 mmol/mol) (positive likelihood ratio [PLR] 3.7) was identified that optimally distinguished the groups; sex-specific cutoffs were 6.3% (45 mmol/mol) for females (PLR 4.4) and 5.6% (38 mmol/mol) for males (PLR 2.1).
  
  
  CONCLUSIONS
  Identifying youth with type 2 diabetes at risk for rapid loss of glycemic control would allow more targeted therapy. HbA1c is a clinically accessible measure to identify high risk for loss of glycemic control on oral therapy. Adolescents with type 2 diabetes unable to attain a non-diabetes range HbA1c on metformin are at increased risk for rapid loss of glycemic control.
authors.affiliation: Section of Endocrinology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.
authors.forename: Phil
authors.initials: P
authors.lastname: Zeitler
authors.affiliation: George Washington University Biostatistics Center, Rockville, MD khirst@bsc.gwu.edu.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Hirst
authors.affiliation: University of Oklahoma College of Medicine, Oklahoma City, OK.
authors.forename: Kenneth C
authors.initials: KC
authors.lastname: Copeland
authors.affiliation: George Washington University Biostatistics Center, Rockville, MD.
authors.forename: Laure
authors.initials: L
authors.lastname: El Ghormli
authors.affiliation: Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
authors.forename: Lorraine
authors.initials: L
authors.lastname: Levitt Katz
authors.affiliation: Massachusetts General Hospital, Harvard Medical School, Boston, MA.
authors.forename: Lynne L
authors.initials: LL
authors.lastname: Levitsky
authors.affiliation: Division of Diabetes, Endocrinology and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.
authors.forename: Barbara
authors.initials: B
authors.lastname: Linder
authors.affiliation: Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, OH.
authors.forename: Paul
authors.initials: P
authors.lastname: McGuigan
authors.affiliation: Washington University School of Medicine, St. Louis, MO.
authors.forename: Neil H
authors.initials: NH
authors.lastname: White
authors.affiliation: Washington University School of Medicine, St. Louis, MO.
authors.forename: Denise
authors.initials: D
authors.lastname: Wilfley
mesh_terms: D000293:Adolescent; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin