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Clinical Trial
. 2010 Nov 1;4(6):1400-7.
doi: 10.1177/193229681000400615.

Multicenter user evaluation of ACCU-CHEK® Combo, an integrated system for continuous subcutaneous insulin infusion

David Kerr  1 , Roel P L M Hoogma, Andreas Buhr, Bettina Petersen, Fred E M G Storms; study investigators
Affiliations
Clinical Trial

Multicenter user evaluation of ACCU-CHEK® Combo, an integrated system for continuous subcutaneous insulin infusion

David Kerr et al. J Diabetes Sci Technol. .

Abstract

Background: The aim of this study was to evaluate a newly developed system for insulin delivery incorporating a multifunctional blood glucose meter and a remotely controlled insulin pump (ACCU-CHEK® Combo system) in established pump users with type 1 diabetes. The technology was assessed both from device performance and subject usability perspectives.

Method: A multicenter, prospective, single group study was carried out in five centers in the Netherlands and four centers in the United Kingdom for more than 6 months. The study was divided into two phases: Phase 1 (4 weeks) for device validation purposes and phase 2 (22 weeks) to observe the impact of the system on metabolic control, patient satisfaction [using the Diabetes Treatment Satisfaction Questionnaire (DTSQ)] and device safety.

Results: Eighty subjects completed the planned study period. There were no unexpected device errors. Treatment satisfaction was high at baseline and further increased to study end (DTSQ change version: sum score, 10.6±7.2; scale score range, -18 to +18, p<0.0001). Hemoglobin A1c improved continuously over time, from 7.9% (±0.9%) to 7.7% (±0.8%) at month 3 (p<0.001) and 7.6% (±0.8%) at month 6 (p<0.0001). The frequency of severe hypoglycemia was 0.08 per patient years. There was no case of ketoacidosis.

Conclusions: The new system was evaluated by experienced continuous subcutaneous insulin infusion users as safe in daily practice and associated with favorable treatment satisfaction and a modest improvement in glycemic control.

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Figures

Figure 1
Figure 1
Treatment satisfaction development (mean ± SD DTSQc scores at study end). The asterisks indicate p < 0.0001 (Wilcoxon signed rank test).
Figure 2
Figure 2
HbA1c changes compared to baseline (mean ± SD).
See this image and copyright information in PMC

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