Sensor-augmented insulin pump therapy: results of the first randomized treat-to-target study.
Objective
- to evaluate the clinical effectiveness and safety of a device that combines an insulin pump with real-time continuous glucose monitoring (CGM), compared to using an insulin pump with standard blood glucose monitoring systems.
METHODS
6-month- randomized, multicenter, treat-to-target study
146 subjects
- treated with continuous subcutaneous insulin infusion
- age between 12 and 72 years with type 1 diabetes
- initial A1C levels of >or=7.5%.
- Subjects were randomized
- pump therapy with real-time CGM (sensor group [SG])
- to pump therapy and self-monitoring of blood glucose only (control group [CG])
Clinical effectiveness and safety were evaluated.
RESULTS:
- A1C levels decreased (P<0.001) from baseline (8.44+/-0.70%) in both groups (SG, -0.71+/-0.71%; CG, -0.56+/-0.072%)
- SG subjects showed no change in mean hypoglycemia area under the curve (AUC)
- CG subjects showed an increase (P=0.001) in hypoglycemia AUC during the blinded periods of the study.
- The between-group difference in hypoglycemia AUC was significant (P<0.0002).
- >60% sensor utilization was associated with A1C reduction (P=0.0456).
CONCLUSIONS:
- A1C reduction was no different between the two groups.
- Subjects in the CG group had increased hypoglycemia AUC and number of events during blinded CGM use
- Subjects with greater sensor utilization showed a greater improvement in A1C levels.
Reference: Diabetes Technol Ther. 2008 Oct;10(5):377-83.
