Sensor-augmented insulin pump therapy: results of the first randomized treat-to-target study

Diabetes Technology & Therapeutics
Irl B HirschBruce A Buckingham

Abstract

The objective of the study was to evaluate the clinical effectiveness and safety of a device that combines an insulin pump with real-time continuous glucose monitoring (CGM), compared to using an insulin pump with standard blood glucose monitoring systems. This 6-month, randomized, multicenter, treat-to-target study enrolled 146 subjects treated with continuous subcutaneous insulin infusion between the ages of 12 and 72 years with type 1 diabetes and initial A1C levels of >or=7.5%. Subjects were randomized to pump therapy with real-time CGM (sensor group [SG]) or to pump therapy and self-monitoring of blood glucose only (control group [CG]). Clinical effectiveness and safety were evaluated. A1C levels decreased (P<0.001) from baseline (8.44+/-0.70%) in both groups (SG, -0.71+/-0.71%; CG, -0.56+/-0.072%); however, between-group differences did not achieve significance. SG subjects showed no change in mean hypoglycemia area under the curve (AUC), whereas CG subjects showed an increase (P=0.001) in hypoglycemia AUC during the blinded periods of the study. The between-group difference in hypoglycemia AUC was significant (P<0.0002). Greater than 60% sensor utilization was associated with A1C reduction (P=0.0456). Fourteen severe hyp...Continue Reading

Associated Clinical Trials

Nov 18, 2011·Michael R. Rickels, MD, MS

References


❮ Previous
Next ❯

Citations

Mar 13, 2010·Diabetologia·J Hermanides, J H DeVries
Jul 14, 2012·Current Diabetes Reports·Robert Henry Slover
Aug 15, 2013·Current Diabetes Reports·Daniel DeSalvo, Bruce Buckingham
Jul 1, 2010·The New England Journal of Medicine·Richard M BergenstalUNKNOWN STAR 3 Study Group
Jan 10, 2009·Diabetes Technology & Therapeutics·Mark Peyrot, Richard R Rubin
Aug 22, 2008·Diabetes Technology & Therapeutics·Satish K Garg
Jul 21, 2009·Diabetes Technology & Therapeutics·Satish K Garg
Jul 21, 2009·Diabetes Technology & Therapeutics·R Paul WadwaH Peter Chase
Jul 21, 2009·Diabetes Technology & Therapeutics·Lisa K Gilliam, Irl B Hirsch
Jul 21, 2009·Diabetes Technology & Therapeutics·Anne Peters
Jul 21, 2009·Diabetes Technology & Therapeutics·Kristin FabiatoKathleen Dungan
Jul 21, 2009·Diabetes Technology & Therapeutics·Steven V Edelman, Timothy S Bailey
Jul 21, 2009·Diabetes Technology & Therapeutics·Jay S Skyler
Jun 11, 2010·Diabetes Technology & Therapeutics·David Kerr, Tolu Olateju
Jun 11, 2010·Diabetes Technology & Therapeutics·Irl B Hirsch
Feb 3, 2011·Diabetes Technology & Therapeutics·Andrea E ScaramuzzaUNKNOWN Diabetes Study Group of the Italian Society of Paediatric Endocrinology and Diabetology
Mar 2, 2011·Diabetes Technology & Therapeutics·Daniela ElleriRoman Hovorka
Sep 22, 2011·Diabetes Technology & Therapeutics·Jaime M Realsen, H Peter Chase
Dec 3, 2011·Diabetes Technology & Therapeutics·Richard R RubinUNKNOWN STAR 3 Study Group
Dec 8, 2011·Diabetes Technology & Therapeutics·Desmond Barry KeenanRajiv V Shah
Sep 29, 2012·Diabetes Technology & Therapeutics·Signe Schmidt, Kirsten Nørgaard
May 2, 2013·Diabetes Technology & Therapeutics·Jesus Moreno-FernandezInes Rosa Gomez
Aug 18, 2010·International Journal of Clinical Practice. Supplement·B W Bode, T Battelino
Nov 10, 2011·International Journal of Clinical Practice. Supplement·S Shalitin, H Peter Chase
Nov 10, 2011·International Journal of Clinical Practice. Supplement·A LibermanM Phillip
Oct 27, 2012·International Journal of Pediatric Endocrinology·Neesha Ramchandani, Rubina A Heptulla
Mar 28, 2013·International Journal of Pediatric Endocrinology·Noelle S Larson, Jordan E Pinsker
Nov 4, 2011·European Journal of Endocrinology·J Hans DeVries
Jan 1, 2010·Sensors·Isabel TorresManuel Aguilar-Diosdado
Apr 15, 2009·Biomedical Papers of the Medical Faculty of the University Palacký, Olomouc, Czechoslovakia·Karolina PetersonRudolf Chlup
Sep 10, 2014·Diabetes & Metabolic Syndrome·Jothydev KesavadevVijay Vishwanathan
Jun 12, 2014·Diabetes Technology & Therapeutics·Zeinab MahmoudiOle Hejlesen
Jun 18, 2011·Postgraduate Medicine·Jeff Unger, Christopher Parkin
Apr 23, 2014·Expert Opinion on Drug Delivery·Martin Tauschmann, Roman Hovorka
Jan 20, 2016·Diabetes Technology & Therapeutics·Lutz Heinemann, J Hans DeVries
May 16, 2014·Canadian Journal of Diabetes·Lori D BerardVincent Woo

❮ Previous
Next ❯

Related Concepts

Related Feeds

Autoimmune Diabetes & Tolerance

Patients with type I diabetes lack insulin-producing beta cells due to the loss of immunological tolerance and autoimmune disease. Discover the latest research on targeting tolerance to prevent diabetes.