Evaluation of an Algorithm to Guide Patients with Type I Diabetes Treated with Continuous Subcutaneous Insulin Infusion (CSII) on How to Respond to Real-Time Continuous Glucose Levels- A Randomised Control Trial.

  1. David N. O'Neal, MD (dno{at}unimelb.edu.au)1
  1. 1The University of Melbourne Dept of Medicine, St Vincent's Hospital, Fitzroy, Australia
  2. 2Dept of Endocrinology and Diabetes, Royal Children's Hospital Melbourne and Murdoch Childrens Research Institute, Parkville, Victoria, Australia
  3. 3Dept of Diabetes and Endocrinology, The Royal Melbourne Hospital, Parkville, Australia
  4. 4Dept of Endocrinology and Diabetes, Western Hospital, Footscray, Australia
  5. 5Dept of Diabetes, Southern Health, Clayton, Australia
  6. 6Monash University, Dept of Pediatrics and School of Psychology, Psychiatry and Psychological Medicine, Monash Medical Centre, Clayton, Australia
  7. 7Onemda VicHealth Koori Health Unit, Centre for Health and Society, School of Population Health, The University of Melbourne, Parkville, Australia

Abstract

Objective: To evaluate an algorithm guiding responses of Continuous Subcutaneous Insulin Infusion (CSII) treated Type 1 diabetes (T1D) patients using real time-continuous glucose monitoring (RT-CGM).

Research Design and Methods: Sixty CSII-treated T1D participants (13-70Y, including adult and adolescent subgroups, HbA1c≤9.5%) randomised in age, gender and HbA1c matched pairs. Phase 1: Open 16 week multi-center randomised controlled trial. Group A: CSII/RT-CGM with algorithm. Group B: CSII/RT-CGM without algorithm. Primary outcome: Difference in time in target (4-10mmol/L) glucose range on six-day masked-CGM. Secondary outcomes: Differences in HbA1c, low (≤3.9mmol/L) glucose CGM time and glycemic variability. Phase 2: Week 16-32 follow-up: Group A: Returned to usual care. Group B: Provided algorithm. Glycemia parameters as above. Comparisons were made between baseline and 16 and 32 weeks.

Results: Phase 1: Withdrawals left 29/30 (Group A) and 28/30 (Group B) subjects. Change in target glucose time did not differ between groups. HbA1c (mean[95%CI]) fell (7.9[7.7-8.2]% to 7.6[7.2-8.0]%; p<0.03) in Group A but not Group B (7.8[7.5-8.1]% to 7.7[7.3-8.0]% p=NS) with no difference between groups. More of Group A achieved HbA1c≤7% than Group B (2/29 to 14/29 vs. 4/28 to 7/28; p=0.015). Phase 2: One participant was lost from each group. Group A HbA1c returned to baseline with RT-CGM discontinuation, but did not change in Group B who continued RT-CGM with algorithm addition.

Conclusions: Early but not late algorithm provision to T1D patients using CSII/RT-CGM did not increase target glucose time but increased HbA1c ≤7% achievement. Upon RT-CGM cessation HbA1c returned to baseline.

Footnotes

    • Received August 9, 2009.
    • Accepted February 25, 2010.

This Article

  1. Diabetes Care
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