Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: The RealTrend study

  1. Denis Raccah, MD, PHD (denis.raccah{at}mail.ap-hm.fr)1,
  2. Véronique Sulmont, MD2,
  3. Yves Reznik, MD, PHD3,
  4. Bruno Guerci, MD, PHD4,
  5. Eric Renard, MD, PHD5,
  6. Hélène Hanaire, MD, PHD6,
  7. Nathalie Jeandidier, MD, PHD7 and
  8. Marc Nicolino, MD, PHD8
  1. From the 1University Hospital Sainte Marguerite, Marseille, France
  2. 2American Memorial Hospital, Children's Hospital, Reims, France
  3. 3Côte de Nacre Hospital, Caen, France
  4. 4CHU de Nancy & University Nancy, France
  5. 5CHU Montpellier & University Montpellier, France
  6. 6CHU Toulouse & University Toulouse, France
  7. 7University Louis Pasteur, Hospital, Strasbourg, France
  8. 8Hospital Femme-Mère-Enfant, Lyon, France

    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.

    Research design and 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 (HbA1c ≥ 8%) being treated with multiple daily injections (MDI). 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 (CSII group). Outcome measures included HbA1c and glycemic variability.

    Results: A total of 115 patients completed the study. Between baseline and trial end, HbA1c 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 considering the 91 patients who were fully protocol-compliant (including CGM sensor wear ≥ 70% of the time), HbA1c 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 HbA1c 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.

    Footnotes

      • Received April 21, 2009.
      • Accepted August 29, 2009.

    This Article

    1. Diabetes Care
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