Effectiveness of Early Intensive Therapy on β-Cell Preservation in Type 1 Diabetes
- Bruce Buckingham, MD1,
- Roy W. Beck, MD, PHD2,
- Katrina J. Ruedy, MSPH2⇑,
- Peiyao Cheng, MPH2,
- Craig Kollman, PHD2,
- Stuart A. Weinzimer, MD3,
- Linda A. DiMeglio, MD, MPH4,
- Andrew A. Bremer, MD, PHD5,
- Robert Slover, MD6,
- William V. Tamborlane, MD3,
- Diabetes Research in Children Network (DirecNet) and Type 1 Diabetes TrialNet Study Groups*
- 1Stanford University, Pediatric Endocrinology, Stanford, California
- 2Jaeb Center for Health Research, Tampa, Florida
- 3Yale University, Pediatric Endocrinology, New Haven, Connecticut
- 4Department of Pediatrics, Section of Pediatric Endocrinology/Diabetology, Indiana University, Riley Hospital for Children, Indianapolis, Indiana
- 5Division of Pediatric Endocrinology, Vanderbilt University Medical Center, Nashville, Tennessee
- 6Pediatrics, Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora, Colorado
- Corresponding author: Katrina J. Ruedy, .
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.
- © 2013 by the American Diabetes Association.
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