Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes
Richard M Bergenstal, William V Tamborlane, Andrew Ahmann, John B Buse, George Dailey, Stephen N Davis, Carol Joyce, Tim Peoples, Bruce A Perkins, John B Welsh, Steven M Willi, Michael A Wood, STAR 3 Study Group, W S Lane, K Arey, T Przestrzelski, S Mehta, L Laffel, J Aggarwal, K Pratt, J B Buse, M Duclos, J Largay, K Osei, C Casey-Boyer, H Breedlove, R Slover 2nd, S Kassels, S Sullivan, J B Green, J English-Jones, M A Wood, E Gleason, L Wagner, R J Tanenberg, C Knuckey, D R Liljenquist, J E Liljenquist, B Sulik, R L Houlden, T LaVallee, A Breen, R Barrett, G Dailey, R Rosal, J Shartel, L Myers, D Ballard, M Meredith, C Trantow, L F Meneghini, J Sparrow-Bodenmiller, R Agramonte, R M Bergenstal, A B Criego, S Borgman, M E May, S N Davis, C Root, S A Weinzimer, L Carria, J Sherr, M Daniels, J S Krantz, H Speer, J Less, S M Willi, T Calvano, E Garth, A Ahmann, C Bogan, V Chambers, B Wollam, Y C Kudva, B Wirt, C Orlowski, S Bates, B Johnson, J C Reed 3rd, J Tapia, K Wardell, S Newsome, C Joyce, D Gibbons, J O'Leary, N H White, M Coleman, R C McEvoy, C Girard, C M Foster, T Brown, E Nuttall, B A Perkins, A Orszag, H Tildesley, B Pottinger, R A Guthrie, J Dvorak, B Childs, T Battelino, S N Davis, E S Horton, S W Lee, R R Rubin, K A Schulman, W V Tamborlane, Richard M Bergenstal, William V Tamborlane, Andrew Ahmann, John B Buse, George Dailey, Stephen N Davis, Carol Joyce, Tim Peoples, Bruce A Perkins, John B Welsh, Steven M Willi, Michael A Wood, STAR 3 Study Group, W S Lane, K Arey, T Przestrzelski, S Mehta, L Laffel, J Aggarwal, K Pratt, J B Buse, M Duclos, J Largay, K Osei, C Casey-Boyer, H Breedlove, R Slover 2nd, S Kassels, S Sullivan, J B Green, J English-Jones, M A Wood, E Gleason, L Wagner, R J Tanenberg, C Knuckey, D R Liljenquist, J E Liljenquist, B Sulik, R L Houlden, T LaVallee, A Breen, R Barrett, G Dailey, R Rosal, J Shartel, L Myers, D Ballard, M Meredith, C Trantow, L F Meneghini, J Sparrow-Bodenmiller, R Agramonte, R M Bergenstal, A B Criego, S Borgman, M E May, S N Davis, C Root, S A Weinzimer, L Carria, J Sherr, M Daniels, J S Krantz, H Speer, J Less, S M Willi, T Calvano, E Garth, A Ahmann, C Bogan, V Chambers, B Wollam, Y C Kudva, B Wirt, C Orlowski, S Bates, B Johnson, J C Reed 3rd, J Tapia, K Wardell, S Newsome, C Joyce, D Gibbons, J O'Leary, N H White, M Coleman, R C McEvoy, C Girard, C M Foster, T Brown, E Nuttall, B A Perkins, A Orszag, H Tildesley, B Pottinger, R A Guthrie, J Dvorak, B Childs, T Battelino, S N Davis, E S Horton, S W Lee, R R Rubin, K A Schulman, W V Tamborlane
Abstract
Background: Recently developed technologies for the treatment of type 1 diabetes mellitus include a variety of pumps and pumps with glucose sensors.
Methods: In this 1-year, multicenter, randomized, controlled trial, we compared the efficacy of sensor-augmented pump therapy (pump therapy) with that of a regimen of multiple daily insulin injections (injection therapy) in 485 patients (329 adults and 156 children) with inadequately controlled type 1 diabetes. Patients received recombinant insulin analogues and were supervised by expert clinical teams. The primary end point was the change from the baseline glycated hemoglobin level.
Results: At 1 year, the baseline mean glycated hemoglobin level (8.3% in the two study groups) had decreased to 7.5% in the pump-therapy group, as compared with 8.1% in the injection-therapy group (P<0.001). The proportion of patients who reached the glycated hemoglobin target (<7%) was greater in the pump-therapy group than in the injection-therapy group. The rate of severe hypoglycemia in the pump-therapy group (13.31 cases per 100 person-years) did not differ significantly from that in the injection-therapy group (13.48 per 100 person-years, P=0.58). There was no significant weight gain in either group.
Conclusions: In both adults and children with inadequately controlled type 1 diabetes, sensor-augmented pump therapy resulted in significant improvement in glycated hemoglobin levels, as compared with injection therapy. A significantly greater proportion of both adults and children in the pump-therapy group than in the injection-therapy group reached the target glycated hemoglobin level. (Funded by Medtronic and others; ClinicalTrials.gov number, NCT00417989.)
2010 Massachusetts Medical Society
Source: PubMed