Evaluation of an Algorithm to Guide Patients With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion on How to Respond to Real-Time Continuous Glucose Levels
A randomized controlled trial
- Alicia J. Jenkins, MD1,
- Balasubramanium Krishnamurthy, MD1,
- James D. Best, MD1,
- Fergus J. Cameron, MD2,
- Peter G. Colman, MD3,
- Steven Farish, MED1,
- Peter S. Hamblin, FRACP4,
- Michele A. O'Connell, MRCPI2,
- Christine Rodda, PHD6,
- Kevin Rowley, PHD7,
- Helena Teede, PHD5 and
- David N. O'Neal, MD1
- 1Department of Medicine, The University of Melbourne, St. Vincent's Hospital, Fitzroy, Victoria, Australia;
- 2Department of Endocrinology and Diabetes, Royal Children's Hospital, Melbourne, and Murdoch Childrens Research Institute, Parkville, Victoria, Australia;
- 3Department of Diabetes and Endocrinology, The Royal Melbourne Hospital, Parkville, Victoria, Australia;
- 4Department of Endocrinology and Diabetes, Western Hospital, Footscray, Victoria, Australia;
- 5Department of Diabetes, Southern Health, Clayton, Victoria, Australia;
- 6Department of Pediatrics and School of Psychology, Psychiatry and Psychological Medicine, Monash University, and Monash Medical Centre, Clayton, Victoria, Australia;
- 7Onemda VicHealth Koori Health Unit, Centre for Health and Society, School of Population Health, The University of Melbourne, Parkville, Victoria, Australia.
- Corresponding author: David N. O'Neal, dno{at}unimelb.edu.au.
Abstract
OBJECTIVE To evaluate an algorithm guiding responses of continuous subcutaneous insulin infusion (CSII)–treated type 1 diabetic patients using real-time continuous glucose monitoring (RT-CGM).
RESEARCH DESIGN AND METHODS Sixty CSII-treated type 1 diabetic participants (aged 13–70 years, including adult and adolescent subgroups, with A1C ≤9.5%) were randomized in age-, sex-, and A1C-matched pairs. Phase 1 was an open 16-week multicenter randomized controlled trial. Group A was treated with CSII/RT-CGM with the algorithm, and group B was treated with CSII/RT-CGM without the algorithm. The primary outcome was the difference in time in target (4–10 mmol/l) glucose range on 6-day masked CGM. Secondary outcomes were differences in A1C, low (≤3.9 mmol/l) glucose CGM time, and glycemic variability. Phase 2 was the week 16–32 follow-up. Group A was returned to usual care, and group B was provided with the algorithm. Glycemia parameters were as above. Comparisons were made between baseline and 16 weeks and 32 weeks.
RESULTS In phase 1, after withdrawals 29 of 30 subjects were left in group A and 28 of 30 subjects were left in group B. The change in target glucose time did not differ between groups. A1C fell (mean 7.9% [95% CI 7.7–8.2to 7.6% [7.2–8.0]; P < 0.03) in group A but not in group B (7.8% [7.5–8.1] to 7.7 [7.3–8.0]; NS) with no difference between groups. More subjects in group A achieved A1C ≤7% than those in group B (2 of 29 to 14 of 29 vs. 4 of 28 to 7 of 28; P = 0.015). In phase 2, one participant was lost from each group. In group A, A1C returned to baseline with RT-CGM discontinuation but did not change in group B, who continued RT-CGM with addition of the algorithm.
CONCLUSIONS Early but not late algorithm provision to type 1 diabetic patients using CSII/RT-CGM did not increase the target glucose time but increased achievement of A1C ≤7%. Upon RT-CGM cessation, A1C returned to baseline.
Footnotes
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Clinical trial reg. no. ACTRN12607000198426, www.anzctr.org.au.
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The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
- © 2010 by the American Diabetes Association.
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