Effectiveness of Early Intensive Therapy on β-Cell Preservation in Type 1 Diabetes

  1. Diabetes Research in Children Network (DirecNet) and Type 1 Diabetes TrialNet Study Groups*
  1. 1Stanford University, Pediatric Endocrinology, Stanford, California
  2. 2Jaeb Center for Health Research, Tampa, Florida
  3. 3Yale University, Pediatric Endocrinology, New Haven, Connecticut
  4. 4Department of Pediatrics, Section of Pediatric Endocrinology/Diabetology, Indiana University, Riley Hospital for Children, Indianapolis, Indiana
  5. 5Division of Pediatric Endocrinology, Vanderbilt University Medical Center, Nashville, Tennessee
  6. 6Pediatrics, Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora, Colorado
  1. Corresponding author: Katrina J. Ruedy, direcnet{at}


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.

RESEARCH DESIGN AND 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.


  • * A complete list of the writing committee and members of the Diabetes Research in Children Network and TrialNet Study Groups can be found in the Supplementary Data online.

  • Received May 6, 2013.
  • Accepted July 24, 2013.

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