Background: Sensor-augmented pump (SAP) therapy can improve glycemic control, compared with multiple daily insulin injections or with insulin pump therapy alone, without increasing the risk of hypoglycemia. Subjects and Methods: A 12-month observational study in patients with type 1 diabetes treated with continuous subcutaneous insulin infusion (CSII), upon the introduction of continuous glucose monitoring (CGM), was conducted in 15 countries (in Europe and in Israel) to document the real-life use of SAP and assess which variables are associated with improvement in type 1 diabetes management.
Results: Data from 263 patients (38% male; mean age, 28.0 +/- 15.7 years [range, 1-69 years]; body mass index, 23.3 +/- 4.9 kg/m(2); diabetes duration, 13.9 +/- 10.7 years; CSII duration, 2.6 +/- 3 years) were collected. Baseline mean glycated hemoglobin A1c (HbA(1c)) was 8.1 +/- 1.4%; 82% had suboptimal HbA(1c) (>= 7%).
The average sensor use for 12 months was 30% (range, 0-94%), and sensor use decreased with time (first 3 months, 37%; last 3 months, 27%). Factors associated with improvement in HbA(1c) after 12 months in patients with baseline HbA(1c) >= 7% were high baseline HbA(1c) (P < 0.001), older age group (P < 0.001), and more frequent sensor use (P = 0.047).
Significantly less hospitalization, increased treatment satisfaction, and reduced fear of hypoglycemia were reported after 12 months of SAP. Conclusions: This is the largest and longest multicenter prospective observational study providing real-life data on SAP.
These results are consistent with those of controlled trials showing the effectiveness of CGM in pump users.