title: Effectiveness of early intensive therapy on β-cell preservation in type 1 diabetes.
abstract: OBJECTIVE
  To assess effectiveness of inpatient hybrid closed-loop control (HCLC) followed by outpatient sensor-augmented pump (SAP) therapy initiated within 7 days of diagnosis of type 1 diabetes on the preservation of β-cell function at 1 year.
  
  
  METHODS
  Sixty-eight individuals (mean age 13.3 ± 5.7 years; 35% female, 92% Caucasian) were randomized to HCLC followed by SAP therapy (intensive group; N = 48) or to the usual-care group treated with multiple daily injections or insulin pump therapy (N = 20). Primary outcome was C-peptide concentrations during mixed-meal tolerance tests at 12 months.
  
  
  RESULTS
  Intensive-group participants initiated HCLC a median of 6 days after diagnosis for a median duration of 71.3 h, during which median participant mean glucose concentration was 140 mg/dL (interquartile range 134-153 mg/dL). During outpatient SAP, continuous glucose monitor (CGM) use decreased over time, and at 12 months, only 33% of intensive participants averaged sensor use ≥6 days/week. In the usual-care group, insulin pump and CGM use were initiated prior to 12 months by 15 and 5 participants, respectively. Mean HbA1c levels were similar in both groups throughout the study. At 12 months, the geometric mean (95% CI) of C-peptide area under the curve was 0.43 (0.34-0.52) pmol/mL in the intensive group and 0.52 (0.32-0.75) pmol/mL in the usual-care group (P = 0.49). Thirty-seven (79%) intensive and 16 (80%) usual-care participants had a peak C-peptide concentration ≥0.2 pmol/mL (P = 0.30).
  
  
  CONCLUSIONS
  In new-onset type 1 diabetes, HCLC followed by SAP therapy did not provide benefit in preserving β-cell function compared with current standards of care.
authors.affiliation: Corresponding author: Katrina J. Ruedy, direcnet@jaeb.org.
authors.forename: Bruce
authors.initials: B
authors.lastname: Buckingham
authors.forename: Roy W
authors.initials: RW
authors.lastname: Beck
authors.forename: Katrina J
authors.initials: KJ
authors.lastname: Ruedy
authors.forename: Peiyao
authors.initials: P
authors.lastname: Cheng
authors.forename: Craig
authors.initials: C
authors.lastname: Kollman
authors.forename: Stuart A
authors.initials: SA
authors.lastname: Weinzimer
authors.forename: Linda A
authors.initials: LA
authors.lastname: DiMeglio
authors.forename: Andrew A
authors.initials: AA
authors.lastname: Bremer
authors.forename: Robert
authors.initials: R
authors.lastname: Slover
authors.forename: William V
authors.initials: WV
authors.lastname: Tamborlane
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000378:metabolism*; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D050417:Insulin-Secreting Cells / Q000187:drug effects / Q000502:physiology*; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin