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Original Research
Recovery of Hypoglycemia Awareness in Long-Standing Type 1 Diabetes: A Multicenter 2 × 2 Factorial Randomized Controlled Trial Comparing Insulin Pump With Multiple Daily Injections and Continuous With Conventional Glucose Self-Monitoring (HypoCOMPaSS)
Stuart A. Little, Lalantha Leelarathna, Emma Walkinshaw, Horng Kai Tan, Olivia Chapple, Alexandra Lubina-Solomon, Thomas J. Chadwick, Shalleen Barendse, Deborah D. Stocken, Catherine Brennand, Sally M. Marshall, Ruth Wood, Jane Speight, David Kerr, Daniel Flanagan, Simon R. Heller, Mark L. Evans, James A.M. Shaw
Diabetes Care 2014 May; DC_140030. https://doi.org/10.2337/dc14-0030
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Abstract

OBJECTIVE To determine whether impaired awareness of hypoglycemia (IAH) can be improved and severe hypoglycemia (SH) prevented in type 1 diabetes, we compared an insulin pump (continuous subcutaneous insulin infusion [CSII]) with multiple daily injections (MDIs) and adjuvant real-time continuous glucose monitoring (RT) with conventional self-monitoring of blood glucose (SMBG).

RESEARCH DESIGN AND METHODS A 24-week 2 × 2 factorial randomized controlled trial in adults with type 1 diabetes and IAH was conducted. All received comparable education, support, and congruent therapeutic targets aimed at rigorous avoidance of biochemical hypoglycemia without relaxing overall control. Primary end point was between-intervention difference in 24-week hypoglycemia awareness (Gold score).

RESULTS A total of 96 participants (mean diabetes duration 29 years) were randomized. Overall, biochemical hypoglycemia (≤3.0 mmol/L) decreased (53 ± 63 to 24 ± 56 min/24 h; P = 0.004 [t test]) without deterioration in HbA1c. Hypoglycemia awareness improved (5.1 ± 1.1 to 4.1 ± 1.6; P = 0.0001 [t test]) with decreased SH (8.9 ± 13.4 to 0.8 ± 1.8 episodes/patient-year; P = 0.0001 [t test]). At 24 weeks, there was no significant difference in awareness comparing CSII with MDI (4.1 ± 1.6 vs. 4.2 ± 1.7; difference 0.1; 95% CI −0.6 to 0.8) and RT with SMBG (4.3 ± 1.6 vs. 4.0 ± 1.7; difference −0.3; 95% CI −1.0 to 0.4). Between-groups analyses demonstrated comparable reductions in SH, fear of hypoglycemia, and insulin doses with equivalent HbA1c. Treatment satisfaction was higher with CSII than MDI (32 ± 3 vs. 29 ± 6; P = 0.0003 [t test]), but comparable with SMBG and RT (30 ± 5 vs. 30 ± 5; P = 0.79 [t test]).

CONCLUSIONS Hypoglycemia awareness can be improved and recurrent SH prevented in long-standing type 1 diabetes without relaxing HbA1c. Similar biomedical outcomes can be attained with conventional MDI and SMBG regimens compared with CSII/RT, although satisfaction was higher with CSII.

Footnotes

  • ↵* A complete list of the members of the HypoCOMPaSS Study Group can be found in the appendix.

  • Received January 5, 2014.
  • Accepted April 1, 2014.
  • © 2014 by the American Diabetes Association.

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.

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Diabetes Care: 44 (4)

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April 2021
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Recovery of Hypoglycemia Awareness in Long-Standing Type 1 Diabetes: A Multicenter 2 × 2 Factorial Randomized Controlled Trial Comparing Insulin Pump With Multiple Daily Injections and Continuous With Conventional Glucose Self-Monitoring (HypoCOMPaSS)
Stuart A. Little, Lalantha Leelarathna, Emma Walkinshaw, Horng Kai Tan, Olivia Chapple, Alexandra Lubina-Solomon, Thomas J. Chadwick, Shalleen Barendse, Deborah D. Stocken, Catherine Brennand, Sally M. Marshall, Ruth Wood, Jane Speight, David Kerr, Daniel Flanagan, Simon R. Heller, Mark L. Evans, James A.M. Shaw
Diabetes Care May 2014, DC_140030; DOI: 10.2337/dc14-0030

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Recovery of Hypoglycemia Awareness in Long-Standing Type 1 Diabetes: A Multicenter 2 × 2 Factorial Randomized Controlled Trial Comparing Insulin Pump With Multiple Daily Injections and Continuous With Conventional Glucose Self-Monitoring (HypoCOMPaSS)
Stuart A. Little, Lalantha Leelarathna, Emma Walkinshaw, Horng Kai Tan, Olivia Chapple, Alexandra Lubina-Solomon, Thomas J. Chadwick, Shalleen Barendse, Deborah D. Stocken, Catherine Brennand, Sally M. Marshall, Ruth Wood, Jane Speight, David Kerr, Daniel Flanagan, Simon R. Heller, Mark L. Evans, James A.M. Shaw
Diabetes Care May 2014, DC_140030; DOI: 10.2337/dc14-0030
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© 2021 by the American Diabetes Association. Diabetes Care Print ISSN: 0149-5992, Online ISSN: 1935-5548.