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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.

Keywords

bolus advice continuous subcutaneous insulin infusion DTSQ HbA1c safety smart insulin pump treatment satisfaction

References

Weissberg-Benchell

Antisdel-Lomaglio

Seshadri

. Insulin pump therapy: A meta-analysis. Diabetes Care. 2003; 26 (4): 1079–87.

Barnard

Lloyd

Skinner

. Systematic literature review: Quality of life associated with insulin pump use in type 1 diabetes. Diabet Med. 2007; 24 (6): 607–17.

Speight

Barendse

. FDA guidance on patient reported outcomes. BMJ. 2010; 340 (7761): c2921.

Todres

Kerr

Keen

. Continuous subcutaneous insulin infusion in type 1 diabetes: Patient experiences of ‘living with a machine’. Diabet Med. 2010; 27 (10); 1201–4.

Bradley

Lewis

. Measures of psychological well-being and treatment satisfaction developed from the responses of people with tablet-treated diabetes. Diabet Med. 1990; 7 (5): 445–51.

Bradley

. The Diabetes Treatment Satisfaction Questionnaire. In: Handbook of Psychology and Diabetes: A Guide to Psychological Measurement in Diabetes Research and Practice. Bradley

, ed. Chur, Switzerland: Harwood Academic Publishers; 1994: 111–32.

Bradley

. Diabetes treatment satisfaction questionnaire. Change version for use alongside status version provides appropriate solution where ceiling effects occur. Diabetes Care. 1999; 22 (3): 530–32.

Howorka

Pumprla

Schlusche

Wagner-Nosiska

Schabmann

Bradley

. Dealing with ceiling baseline treatment satisfaction level in patients with diabetes under flexible, functional insulin treatment: Assessment of improvements in treatment satisfaction with a new insulin analogue. Qual Life Res. 2000; 9 (8): 915–30.

Franke

Legtenberg

Lalla

Lodwig

Heinemann

. Evaluierung einer neuen Insulinpumpe: Ergebnisse einer prospektiven, multizentrischen Beobachtungsstudie vor der Markteinführung. Diabet Stofffwechsel. 2005; 14: 269–76.

10.

Renard

. Insulin pump use in Europe. Diabetes Technol Ther. 2010; 12 (Suppl 1): S29–32.

11.

American Diabetes Association. Standards of Medical Care in Diabetes—2010. Diabetes Care. 2010; 33 (Suppl 1): S11–61.

12.

Eugster

Francis

; the Lawson-Wilkins Drug and Therapeutics Committee. Position statement: Continuous subcutaneous insulin infusion in very young children with type 1 diabetes. Pediatrics. 2006; 118 (4): e1244–49.

13.

Alsaleh

Smith

Taylor

K Keady Sand

. Insulin pumps: From inception to the present and toward the future. J Clin Pharm Ther. 2010; 35 (2): 127–38.

14.

Heinemann

. Insulin pump therapy: What is the evidence for using different types of boluses for coverage of prandial insulin requirements? J Diabetes Sci Technol. 2009; 3 (6): 1490–1500.

15.

Kerr

Olateju

. Pascal's wager: Combining continuous glucose monitoring and continuous subcutaneous insulin infusion. Diabetes Technol Ther. 2010; 12 (Supp 1): S43–50.

16.

Klonoff

Reyes

. Insulin pump safety meeting: Summary report. J Diabetes Sci Technol. 2009; 3 (2): 396–402.

17.

Zhang

Jones

Klonoff

. Second insulin pump safety meeting: Summary report. J Diabetes Sci Technol. 2010; 4 (2): 488–93.

18.

Zhang

Jones

Jetley

. A hazard analysis for a generic insulin infusion pump. J Diabetes Sci Technol. 2010; 4 (2): 263–83.

19.

Kerr

Morton

Whately-Smith

Everett

Begley

. Laboratory-based non-clinical comparison of occlusion rates using three rapid-acting insulin analogs in continuous subcutaneous insulin infusion catheters using low fat rates. J Diabetes Sci Technol. 2008; 2 (3): 450–5.

20.

Hoogma

RPL

Bolli

Bruttomesso

Hammond

Kerr

Krinelke

. Comparison of continuous subcutaneous insulin infusion (CSII) vs. intensive conventional therapy (ICT) in regard to metabolic control. Diabet Med. 2006; 23: 141–7.

21.

Kerr

Marden

. Numeracy and insulin pump therapy. Diabet Med. 2010: 27 (6): 730–1.

22.

Zisser

Wagner

Pleus

Haug

Jendrike

Parkin

Freckmann

. Clinical performance of three bolus calculators in subjects with type 1 diabetes mellitus: Head-to-head-to-head comparison. Diabetes Technol Ther. 2010. (Forthcoming).

Multicenter User Evaluation of ACCU-CHEK® Combo,an Integrated System for Continuous Subcutaneous Insulin Infusion

Abstract

Background:

Method:

Results:

Conclusions:

Keywords

References