The SWITCH study (sensing with insulin pump therapy to control HbA 1c): Design and methods of a randomized controlled crossover trial on sensor-augmented insulin pump efficacy in type 1 diabetes suboptimally controlled with pump therapy

Diabetes Technology and Therapeutics

Volumn 13, Issue 1, 2011, Pages 49-54

  Conget, Ignacio ^a   Battelino, Tadej ^b   Giménez, Marga ^a   Gough, Hannah ^c   Castaneda J ^d   Bolinder, Jan ^e  

^a HOSPITAL CLÍNIC   (Spain)

^b UNIVERSITY MEDICAL CENTRE LJUBLJANA   (Slovenia)

^c Medtronic International Trading Sarl ^*  (Switzerland)

^d MEDTRONIC BAKKEN RESEARCH CENTER   (Netherlands)

^e KAROLINSKA INSTITUTE   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

HEMOGLOBIN A1C; INSULIN;

AGED; ARTICLE; BLOOD GLUCOSE MONITORING; CHILD; CROSSOVER PROCEDURE; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; FEMALE; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN PUMP; INSULIN TREATMENT; MAJOR CLINICAL STUDY; MALE; METABOLIC REGULATION; MULTICENTER STUDY; PATIENT SATISFACTION; PRESCHOOL CHILD; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SENSOR;

ADOLESCENT; ADULT; AGED; CHILD; CROSS-OVER STUDIES; DIABETES MELLITUS, TYPE 1; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; INFUSION PUMPS, IMPLANTABLE; INSULIN; INSULIN INFUSION SYSTEMS; MIDDLE AGED; PATIENT SATISFACTION; YOUNG ADULT;

EID: 78650604192     PISSN: 15209156     EISSN: None     Source Type: Journal    
DOI: 10.1089/dia.2010.0107     Document Type: Article

References (14)

1. Gilliam LK, Hirsch IB: Practical aspects of real-time continuous glucose monitoring. Diabetes Technol Ther 2009; 11(Suppl 1):S75-S82.
2. Deiss D, Bolinder J, Riveline JP, Battelino T, Bosi E, Tubiana- Rufi N, Kerr D, Phillip M: Improved glycemic control in poorly controlled patients with type 1 diabetes using realtime continuous glucose monitoring. Diabetes Care 2006;29:2730-2732.
3. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D: Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med 2008;359:1464-1476.
4. Raccah D, Sulmont V, Reznik Y, Guerci B, Renard E, Hanaire H, Jeandidier N, Nicolino M: Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: The Real- Trend study. Diabetes Care 2009;32:2245-2250.
5. O'Connell MA, Donath S, O'Neal DN, Colman PG, Ambler GR, Jones TW, Davis EA, Cameron FJ: Glycaemic impact of patient-led use of sensor-guided pump therapy in type 1 diabetes: A randomised controlled trial. Diabetologia 2009; 52:1250-1257.
6. Cohen O, Kö rner A, Chlup R, Zoupas CS, Ragozin AK, Wudi K, Bartaskova D, Pappas A, Niederland T, Taybani Z, Barák L, Vazeou A; Central and Eastern Europe, Greece, and Israel Continuous Glucose Sensing Collaborative Study Group: Improved glycemic control through continuous glucose sensor-augmented insulin pump therapy: Prospective results from a community and academic practice patient registry. J Diabetes Sci Technol 2009;3:804-811.
7. Ludvigsson J, Hanas R: Continuous subcutaneous glucose monitoring improved metabolic control in pediatric patients with type 1 diabetes: A controlled crossover study. Pediatrics 2003;111:933-938.
8. DeVries JH, Snoek FJ, Kostense PJ, Masurel N, Heine RJ: A randomized trial of continuous subcutaneous insulin infusion and intensive injection therapy in type 1 diabetes for patients with long-standing poor glycemic control. Diabetes Care 2002;25:2074-2080.
9. Hoogma RP, Hammond PJ, Gomis R, Kerr D, Bruttomesso D, Bouter KP, Wiefels KJ, de la Calle H, Schweitzer DH, Pfohl M, Torlone E, Krinelke LG, Bolli GB; 5-Nations Study Group: Comparison of the effects of continuous subcutaneous insulin infusion (CSII) and NPH-based multiple daily insulin injections (MDI) on glycaemic control and quality of life: Results of the 5-nations trial. Diabet Med 2006;23:141-147.
10. Hirsch IB, Abelseth J, Bode BW, Fischer JS, Kaufman FR, Mastrototaro J, Parkin CG, Wolpert HA, Buckingham BA: Sensor-augmented insulin pump therapy: Results of the first randomized treat-to-target study. Diabetes Technol Ther 2008;10:377-383.
11. Bradley C, Lewis KS: Measures of psychological well-being and treatment satisfaction developed from the responses of people with tablet-treated diabetes. Diabet Med 1990;7:445-451.
12. Varni JW, Seid M, Rode CA: The PedsQL: Measurement model for the pediatric quality of life inventory. Med Care 1999;37:126-139.
13. Senn S: Cross-Over Trials in Clinical Research. Chichester, UK: John Wiley & Sons, 2002.
14. Jones B, Kenward M: Design and Analysis of Cross-Over Trials, 2nd ed. Boca Raton, FL: Chapman & Hall/CRC, 2003.