Continuous glucose monitoring and intensive treatment of type 1 diabetes

William V. Tamborlane, Roy W. Beck, Bruce W. Bode, Bruce Buckingham, H. Peter Chase, Robert Clemons, Rosanna Fiallo-Scharer, Larry A. Fox, Lisa K. Gilliam, Irl B. Hirsch, Elbert S. Huang, Craig Kollman, Aaron J. Kowalski, Lori Laffel, Jean M. Lawrence, Joyce Lee, Nelly Mauras, Michael O'Grady, Katrina J. Ruedy, Michael TanseyEva Tsalikian, Stuart Weinzimer, Darrell M. Wilson, Howard Wolpert, Tim Wysocki, Dongyuan Xing, L. Messer, V. Gage, P. Burdick, K. Milaszewski, K. Pratt, E. Bismuth, J. Keady, M. Lawlor, J. Block, K. Benassi, D. Kucera, J. Coffey, J. Cabbage, G. Shetty, A. Atakov-Castillo, J. Giusti, S. O'Donnell, S. Ghiloni, K. Fitzpatrick, D. Khakpour, K. Englert, J. Permuy, K. O'Neil, L. Tolbert, M. Maeva, B. Sattler, B. Ives, J. Bosson-Heenan, J. Jackson, M. Steffes, J. M. Bucksa, M. L. Nowicki, C. Van Hale, V. Makky, A. Basu, D. O. Meltzer, L. Zhao, R. S. Weinstock, B. J. Anderson, D. Kruger, L. LaVange, H. Rodriguez

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: The value of continuous glucose monitoring in the management of type 1 diabetes mellitus has not been determined. METHODS: In a multicenter clinical trial, we randomly assigned 322 adults and children who were already receiving intensive therapy for type 1 diabetes to a group with continuous glucose monitoring or to a control group performing home monitoring with a blood glucose meter. All the patients were stratified into three groups according to age and had a glycated hemoglobin level of 7.0 to 10.0%. The primary outcome was the change in the glycated hemoglobin level at 26 weeks. RESULTS: The changes in glycated hemoglobin levels in the two study groups varied markedly according to age group (P = 0.003), with a significant difference among patients 25 years of age or older that favored the continuous-monitoring group (mean difference in change, -0.53%; 95% confidence interval [CI], -0.71 to -0.35; P<0.001). The between-group difference was not significant among those who were 15 to 24 years of age (mean difference, 0.08; 95% CI, -0.17 to 0.33; P = 0.52) or among those who were 8 to 14 years of age (mean difference, -0.13; 95% CI, -0.38 to 0.11; P = 0.29). Secondary glycated hemoglobin outcomes were better in the continuous-monitoring group than in the control group among the oldest and youngest patients but not among those who were 15 to 24 years of age. The use of continuous glucose monitoring averaged 6.0 or more days per week for 83% of patients 25 years of age or older, 30% of those 15 to 24 years of age, and 50% of those 8 to 14 years of age. The rate of severe hypoglycemia was low and did not differ between the two study groups; however, the trial was not powered to detect such a difference. CONCLUSIONS: Continuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness of continuous monitoring in children and adolescents. (ClinicalTrials.gov number, NCT00406133.)

Original languageEnglish (US)
Pages (from-to)1464-1476
Number of pages13
JournalNew England Journal of Medicine
Volume359
Issue number14
DOIs
StatePublished - Oct 2 2008

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Glycosylated Hemoglobin A
Type 1 Diabetes Mellitus
Glucose
Confidence Intervals
Group Homes
Control Groups
Therapeutics
Hypoglycemia
Multicenter Studies
Blood Glucose
Age Groups
Clinical Trials

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Tamborlane, W. V., Beck, R. W., Bode, B. W., Buckingham, B., Chase, H. P., Clemons, R., ... Rodriguez, H. (2008). Continuous glucose monitoring and intensive treatment of type 1 diabetes. New England Journal of Medicine, 359(14), 1464-1476. https://doi.org/10.1056/NEJMoa0805017

Continuous glucose monitoring and intensive treatment of type 1 diabetes. / Tamborlane, William V.; Beck, Roy W.; Bode, Bruce W.; Buckingham, Bruce; Chase, H. Peter; Clemons, Robert; Fiallo-Scharer, Rosanna; Fox, Larry A.; Gilliam, Lisa K.; Hirsch, Irl B.; Huang, Elbert S.; Kollman, Craig; Kowalski, Aaron J.; Laffel, Lori; Lawrence, Jean M.; Lee, Joyce; Mauras, Nelly; O'Grady, Michael; Ruedy, Katrina J.; Tansey, Michael; Tsalikian, Eva; Weinzimer, Stuart; Wilson, Darrell M.; Wolpert, Howard; Wysocki, Tim; Xing, Dongyuan; Messer, L.; Gage, V.; Burdick, P.; Milaszewski, K.; Pratt, K.; Bismuth, E.; Keady, J.; Lawlor, M.; Block, J.; Benassi, K.; Kucera, D.; Coffey, J.; Cabbage, J.; Shetty, G.; Atakov-Castillo, A.; Giusti, J.; O'Donnell, S.; Ghiloni, S.; Fitzpatrick, K.; Khakpour, D.; Englert, K.; Permuy, J.; O'Neil, K.; Tolbert, L.; Maeva, M.; Sattler, B.; Ives, B.; Bosson-Heenan, J.; Jackson, J.; Steffes, M.; Bucksa, J. M.; Nowicki, M. L.; Van Hale, C.; Makky, V.; Basu, A.; Meltzer, D. O.; Zhao, L.; Weinstock, R. S.; Anderson, B. J.; Kruger, D.; LaVange, L.; Rodriguez, H.

In: New England Journal of Medicine, Vol. 359, No. 14, 02.10.2008, p. 1464-1476.

Research output: Contribution to journalArticle

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, Messer, L, Gage, V, Burdick, P, Milaszewski, K, Pratt, K, Bismuth, E, Keady, J, Lawlor, M, Block, J, Benassi, K, Kucera, D, Coffey, J, Cabbage, J, Shetty, G, Atakov-Castillo, A, Giusti, J, O'Donnell, S, Ghiloni, S, Fitzpatrick, K, Khakpour, D, Englert, K, Permuy, J, O'Neil, K, Tolbert, L, Maeva, M, Sattler, B, Ives, B, Bosson-Heenan, J, Jackson, J, Steffes, M, Bucksa, JM, Nowicki, ML, Van Hale, C, Makky, V, Basu, A, Meltzer, DO, Zhao, L, Weinstock, RS, Anderson, BJ, Kruger, D, LaVange, L & Rodriguez, H 2008, 'Continuous glucose monitoring and intensive treatment of type 1 diabetes', New England Journal of Medicine, vol. 359, no. 14, pp. 1464-1476. https://doi.org/10.1056/NEJMoa0805017
Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R et al. Continuous glucose monitoring and intensive treatment of type 1 diabetes. New England Journal of Medicine. 2008 Oct 2;359(14):1464-1476. https://doi.org/10.1056/NEJMoa0805017
Tamborlane, William V. ; Beck, Roy W. ; Bode, Bruce W. ; Buckingham, Bruce ; Chase, H. Peter ; Clemons, Robert ; Fiallo-Scharer, Rosanna ; Fox, Larry A. ; Gilliam, Lisa K. ; Hirsch, Irl B. ; Huang, Elbert S. ; Kollman, Craig ; Kowalski, Aaron J. ; Laffel, Lori ; Lawrence, Jean M. ; Lee, Joyce ; Mauras, Nelly ; O'Grady, Michael ; Ruedy, Katrina J. ; Tansey, Michael ; Tsalikian, Eva ; Weinzimer, Stuart ; Wilson, Darrell M. ; Wolpert, Howard ; Wysocki, Tim ; Xing, Dongyuan ; Messer, L. ; Gage, V. ; Burdick, P. ; Milaszewski, K. ; Pratt, K. ; Bismuth, E. ; Keady, J. ; Lawlor, M. ; Block, J. ; Benassi, K. ; Kucera, D. ; Coffey, J. ; Cabbage, J. ; Shetty, G. ; Atakov-Castillo, A. ; Giusti, J. ; O'Donnell, S. ; Ghiloni, S. ; Fitzpatrick, K. ; Khakpour, D. ; Englert, K. ; Permuy, J. ; O'Neil, K. ; Tolbert, L. ; Maeva, M. ; Sattler, B. ; Ives, B. ; Bosson-Heenan, J. ; Jackson, J. ; Steffes, M. ; Bucksa, J. M. ; Nowicki, M. L. ; Van Hale, C. ; Makky, V. ; Basu, A. ; Meltzer, D. O. ; Zhao, L. ; Weinstock, R. S. ; Anderson, B. J. ; Kruger, D. ; LaVange, L. ; Rodriguez, H. / Continuous glucose monitoring and intensive treatment of type 1 diabetes. In: New England Journal of Medicine. 2008 ; Vol. 359, No. 14. pp. 1464-1476.
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title = "Continuous glucose monitoring and intensive treatment of type 1 diabetes",
abstract = "BACKGROUND: The value of continuous glucose monitoring in the management of type 1 diabetes mellitus has not been determined. METHODS: In a multicenter clinical trial, we randomly assigned 322 adults and children who were already receiving intensive therapy for type 1 diabetes to a group with continuous glucose monitoring or to a control group performing home monitoring with a blood glucose meter. All the patients were stratified into three groups according to age and had a glycated hemoglobin level of 7.0 to 10.0{\%}. The primary outcome was the change in the glycated hemoglobin level at 26 weeks. RESULTS: The changes in glycated hemoglobin levels in the two study groups varied markedly according to age group (P = 0.003), with a significant difference among patients 25 years of age or older that favored the continuous-monitoring group (mean difference in change, -0.53{\%}; 95{\%} confidence interval [CI], -0.71 to -0.35; P<0.001). The between-group difference was not significant among those who were 15 to 24 years of age (mean difference, 0.08; 95{\%} CI, -0.17 to 0.33; P = 0.52) or among those who were 8 to 14 years of age (mean difference, -0.13; 95{\%} CI, -0.38 to 0.11; P = 0.29). Secondary glycated hemoglobin outcomes were better in the continuous-monitoring group than in the control group among the oldest and youngest patients but not among those who were 15 to 24 years of age. The use of continuous glucose monitoring averaged 6.0 or more days per week for 83{\%} of patients 25 years of age or older, 30{\%} of those 15 to 24 years of age, and 50{\%} of those 8 to 14 years of age. The rate of severe hypoglycemia was low and did not differ between the two study groups; however, the trial was not powered to detect such a difference. CONCLUSIONS: Continuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness of continuous monitoring in children and adolescents. (ClinicalTrials.gov number, NCT00406133.)",
author = "Tamborlane, {William V.} and Beck, {Roy W.} and Bode, {Bruce W.} and Bruce Buckingham and Chase, {H. Peter} and Robert Clemons and Rosanna Fiallo-Scharer and Fox, {Larry A.} and Gilliam, {Lisa K.} and Hirsch, {Irl B.} and Huang, {Elbert S.} and Craig Kollman and Kowalski, {Aaron J.} and Lori Laffel and Lawrence, {Jean M.} and Joyce Lee and Nelly Mauras and Michael O'Grady and Ruedy, {Katrina J.} and Michael Tansey and Eva Tsalikian and Stuart Weinzimer and Wilson, {Darrell M.} and Howard Wolpert and Tim Wysocki and Dongyuan Xing and L. Messer and V. Gage and P. Burdick and K. Milaszewski and K. Pratt and E. Bismuth and J. Keady and M. Lawlor and J. Block and K. Benassi and D. Kucera and J. Coffey and J. Cabbage and G. Shetty and A. Atakov-Castillo and J. Giusti and S. O'Donnell and S. Ghiloni and K. Fitzpatrick and D. Khakpour and K. Englert and J. Permuy and K. O'Neil and L. Tolbert and M. Maeva and B. Sattler and B. Ives and J. Bosson-Heenan and J. Jackson and M. Steffes and Bucksa, {J. M.} and Nowicki, {M. L.} and {Van Hale}, C. and V. Makky and A. Basu and Meltzer, {D. O.} and L. Zhao and Weinstock, {R. S.} and Anderson, {B. J.} and D. Kruger and L. LaVange and H. Rodriguez",
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TY - JOUR

T1 - Continuous glucose monitoring and intensive treatment of type 1 diabetes

AU - Tamborlane, William V.

AU - Beck, Roy W.

AU - Bode, Bruce W.

AU - Buckingham, Bruce

AU - Chase, H. Peter

AU - Clemons, Robert

AU - Fiallo-Scharer, Rosanna

AU - Fox, Larry A.

AU - Gilliam, Lisa K.

AU - Hirsch, Irl B.

AU - Huang, Elbert S.

AU - Kollman, Craig

AU - Kowalski, Aaron J.

AU - Laffel, Lori

AU - Lawrence, Jean M.

AU - Lee, Joyce

AU - Mauras, Nelly

AU - O'Grady, Michael

AU - Ruedy, Katrina J.

AU - Tansey, Michael

AU - Tsalikian, Eva

AU - Weinzimer, Stuart

AU - Wilson, Darrell M.

AU - Wolpert, Howard

AU - Wysocki, Tim

AU - Xing, Dongyuan

AU - Messer, L.

AU - Gage, V.

AU - Burdick, P.

AU - Milaszewski, K.

AU - Pratt, K.

AU - Bismuth, E.

AU - Keady, J.

AU - Lawlor, M.

AU - Block, J.

AU - Benassi, K.

AU - Kucera, D.

AU - Coffey, J.

AU - Cabbage, J.

AU - Shetty, G.

AU - Atakov-Castillo, A.

AU - Giusti, J.

AU - O'Donnell, S.

AU - Ghiloni, S.

AU - Fitzpatrick, K.

AU - Khakpour, D.

AU - Englert, K.

AU - Permuy, J.

AU - O'Neil, K.

AU - Tolbert, L.

AU - Maeva, M.

AU - Sattler, B.

AU - Ives, B.

AU - Bosson-Heenan, J.

AU - Jackson, J.

AU - Steffes, M.

AU - Bucksa, J. M.

AU - Nowicki, M. L.

AU - Van Hale, C.

AU - Makky, V.

AU - Basu, A.

AU - Meltzer, D. O.

AU - Zhao, L.

AU - Weinstock, R. S.

AU - Anderson, B. J.

AU - Kruger, D.

AU - LaVange, L.

AU - Rodriguez, H.

PY - 2008/10/2

Y1 - 2008/10/2

N2 - BACKGROUND: The value of continuous glucose monitoring in the management of type 1 diabetes mellitus has not been determined. METHODS: In a multicenter clinical trial, we randomly assigned 322 adults and children who were already receiving intensive therapy for type 1 diabetes to a group with continuous glucose monitoring or to a control group performing home monitoring with a blood glucose meter. All the patients were stratified into three groups according to age and had a glycated hemoglobin level of 7.0 to 10.0%. The primary outcome was the change in the glycated hemoglobin level at 26 weeks. RESULTS: The changes in glycated hemoglobin levels in the two study groups varied markedly according to age group (P = 0.003), with a significant difference among patients 25 years of age or older that favored the continuous-monitoring group (mean difference in change, -0.53%; 95% confidence interval [CI], -0.71 to -0.35; P<0.001). The between-group difference was not significant among those who were 15 to 24 years of age (mean difference, 0.08; 95% CI, -0.17 to 0.33; P = 0.52) or among those who were 8 to 14 years of age (mean difference, -0.13; 95% CI, -0.38 to 0.11; P = 0.29). Secondary glycated hemoglobin outcomes were better in the continuous-monitoring group than in the control group among the oldest and youngest patients but not among those who were 15 to 24 years of age. The use of continuous glucose monitoring averaged 6.0 or more days per week for 83% of patients 25 years of age or older, 30% of those 15 to 24 years of age, and 50% of those 8 to 14 years of age. The rate of severe hypoglycemia was low and did not differ between the two study groups; however, the trial was not powered to detect such a difference. CONCLUSIONS: Continuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness of continuous monitoring in children and adolescents. (ClinicalTrials.gov number, NCT00406133.)

AB - BACKGROUND: The value of continuous glucose monitoring in the management of type 1 diabetes mellitus has not been determined. METHODS: In a multicenter clinical trial, we randomly assigned 322 adults and children who were already receiving intensive therapy for type 1 diabetes to a group with continuous glucose monitoring or to a control group performing home monitoring with a blood glucose meter. All the patients were stratified into three groups according to age and had a glycated hemoglobin level of 7.0 to 10.0%. The primary outcome was the change in the glycated hemoglobin level at 26 weeks. RESULTS: The changes in glycated hemoglobin levels in the two study groups varied markedly according to age group (P = 0.003), with a significant difference among patients 25 years of age or older that favored the continuous-monitoring group (mean difference in change, -0.53%; 95% confidence interval [CI], -0.71 to -0.35; P<0.001). The between-group difference was not significant among those who were 15 to 24 years of age (mean difference, 0.08; 95% CI, -0.17 to 0.33; P = 0.52) or among those who were 8 to 14 years of age (mean difference, -0.13; 95% CI, -0.38 to 0.11; P = 0.29). Secondary glycated hemoglobin outcomes were better in the continuous-monitoring group than in the control group among the oldest and youngest patients but not among those who were 15 to 24 years of age. The use of continuous glucose monitoring averaged 6.0 or more days per week for 83% of patients 25 years of age or older, 30% of those 15 to 24 years of age, and 50% of those 8 to 14 years of age. The rate of severe hypoglycemia was low and did not differ between the two study groups; however, the trial was not powered to detect such a difference. CONCLUSIONS: Continuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness of continuous monitoring in children and adolescents. (ClinicalTrials.gov number, NCT00406133.)

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