Multicenter user evaluation of ACCU-CHEK® Combo, an integrated system for continuous subcutaneous insulin infusion
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 perfor...
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Published in | Journal of diabetes science and technology Vol. 4; no. 6; pp. 1400 - 1407 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Diabetes Technology Society
01.11.2010
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Subjects | |
Online Access | Get full text |
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Summary: | 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.
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.
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.
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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Bibliography: | Funding: The study was sponsored by Roche Diabetes Care AG, Burgdorf, Switzerland. Roche Diagnostics GmbH, Mannheim, Germany, acted as European representative for the sponsor. Disclosure: David Kerr has received honoraria for participating in sponsored meetings and advisory boards as well as research support from Roche, Medtronic and Animas, manufacturers of insulin pump devices. Andreas Buhr is an employee of Roche Diabetes Care AG, Burgdorf, Switzerland. Bettina Petersen is an employee of Roche Diagnostics GmbH, Mannheim, Germany. Roel Hoogma has received honoraria for participating in sponsored meetings and advisory boards as well as research support from Roche. Fred Storms has received honoraria for lecturing in meetings of Roche Diagnostics. |
ISSN: | 1932-2968 1932-3107 |
DOI: | 10.1177/193229681000400615 |