학술논문
The SWITCH Study (Sensing With Insulin pump Therapy to Control [HbA.sub.1c]): design and methods of a randomized controlled crossover trial on sensor-augmented insulin pump efficacy in type 1 diabetes suboptimally controlled with pump therapy
Document Type
Report
Author
Source
Diabetes Technology & Therapeutics. January 1, 2011, Vol. 13 Issue 1, p49, 6 p.
Subject
Language
English
ISSN
1520-9156
Abstract
Introduction Real-time (RT) continuous glucose monitoring (CGM) allows people with diabetes to see their glucose levels continuously using a subcutaneous sensor, a transmitter, and a receiving device. (1) Accessibility of [...]
Background: Studies investigating the effect of real-time continuous glucose monitoring (CGM) combined with pump therapy on glycemic outcomes in type 1 diabetes are increasing. Pump therapy is well established as a 'gold standard' for insulin delivery, offering improvements over multiple daily insulin injections. However, there is still a proportion of subjects using continuous subcutaneous insulin infusion in whom goals for metabolic control are far from achieved or benefits of this type of insulin therapy are transient. The SWITCH (Sensing With Insulin pump Therapy to Control [HbA.sub.1c] [hemoglobin A1c]) study is a multicenter, randomized, controlled, crossover study to evaluate if adding CGM to experienced pump patients with suboptimal metabolic control will provide additional insight enabling clinical and therapeutic benefit. Methods: Subjects meeting the inclusion criteria were randomized to Sensor On or Sensor Off arms for 6 months, after a 1-month run-in period. Following a 4-month washout period, the subjects crossed over to the other study arm for 6 months. The primary end point was the between arm difference in [HbA.sub.1c] levels. Among others, additional end points include time spent in different glycemic ranges, percentage of patients with [HbA.sub.1c] Results: Recruitment occurred between January 2008 and February 2009. A total of 153 patients were randomized. Study completion is anticipated in July 2010. Conclusions: The results will establish if adding CGM to existing, capable, insulin pump users can enable better metabolic control.
Background: Studies investigating the effect of real-time continuous glucose monitoring (CGM) combined with pump therapy on glycemic outcomes in type 1 diabetes are increasing. Pump therapy is well established as a 'gold standard' for insulin delivery, offering improvements over multiple daily insulin injections. However, there is still a proportion of subjects using continuous subcutaneous insulin infusion in whom goals for metabolic control are far from achieved or benefits of this type of insulin therapy are transient. The SWITCH (Sensing With Insulin pump Therapy to Control [HbA.sub.1c] [hemoglobin A1c]) study is a multicenter, randomized, controlled, crossover study to evaluate if adding CGM to experienced pump patients with suboptimal metabolic control will provide additional insight enabling clinical and therapeutic benefit. Methods: Subjects meeting the inclusion criteria were randomized to Sensor On or Sensor Off arms for 6 months, after a 1-month run-in period. Following a 4-month washout period, the subjects crossed over to the other study arm for 6 months. The primary end point was the between arm difference in [HbA.sub.1c] levels. Among others, additional end points include time spent in different glycemic ranges, percentage of patients with [HbA.sub.1c] Results: Recruitment occurred between January 2008 and February 2009. A total of 153 patients were randomized. Study completion is anticipated in July 2010. Conclusions: The results will establish if adding CGM to existing, capable, insulin pump users can enable better metabolic control.