The accuracy of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes

Darrell M. Wilson, Roy W. Beck, William V. Tamborlane, Mariya J. Dontchev, Craig Kollman, Peter Chase, Larry A. Fox, Katrina J. Ruedy, Eva Tsalikian, Stuart A. Weinzimer, Rosanna Fiallo-Scharer, Laurel Messer, Barbara Tallant, Michael J. Tansey, Linda F. Larson, Julie Coffey, Joanne Cabbage, Tim Wysocki, Nelly Mauras, Keisha Bird & 25 others Kim Englert, Bruce A. Buckingham, Jennifer M. Block, Paula Clinton, Kimberly Caswell, Elizabeth A. Doyle, Heather Mokotoff, Amy Steffen, Dongyuan Xing, Cynthia R. Stockdale, Judy Jackson, Michael W. Steffes, Jean M. Bucksa, Maren L. Nowicki, Carol A. Van Hale, Vicky Makky, Gilman D. Grave, Mary Horlick, Karen Teff, Karen K. Winer, Dorothy M. Becker, Patricia Cleary, Christopher M. Ryan, Neil H. White, Perrin C. White

Research output: Contribution to journalArticle

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Abstract

OBJECTIVE - To evaluate the accuracy and precision of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes. RESEARCH DESIGN AND METHODS - In 30 children with type 1 diabetes (mean age 11.2 ± 4.1 years), the Navigator glucose values were compared with reference serum glucose values of blood samples obtained in an inpatient clinical research center and measured in a central laboratory using a hexokinase enzymatic method and in an outpatient setting with a FreeStyle meter. Median absolute difference (AD) and median relative absolute difference (RAD) were computed for sensor-reference and sensor-sensor pairs. RESULTS - The median AD and RAD were 17 mg/dl and 12%, respectively, for 1,811 inpatient sensor-reference pairs and 20 mg/dl and 14%, respectively, for 8,639 outpatient pairs. The median RAD between two simultaneous Navigator measurements (n = 1,971) was 13%. Ninety-one percent of sensors in the inpatient setting and 81% of sensors in the outpatient setting had a median RAD ≤20%. CONCLUSIONS - The Navigator's accuracy does not yet approach the accuracy of current-generation home glucose meters, but it is sufficient to believe that the device has the potential to be an important adjunct to treatment of youth with type 1 diabetes.

Original languageEnglish (US)
Pages (from-to)59-64
Number of pages6
JournalDiabetes care
Volume30
Issue number1
DOIs
StatePublished - Jan 1 2007

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Type 1 Diabetes Mellitus
Inpatients
Outpatients
Glucose
Hexokinase
Blood Glucose
Research Design
Equipment and Supplies
Serum
Research
Therapeutics

Cite this

Wilson, D. M., Beck, R. W., Tamborlane, W. V., Dontchev, M. J., Kollman, C., Chase, P., ... White, P. C. (2007). The accuracy of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes. Diabetes care, 30(1), 59-64. https://doi.org/10.2337/dc06-1407

The accuracy of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes. / Wilson, Darrell M.; Beck, Roy W.; Tamborlane, William V.; Dontchev, Mariya J.; Kollman, Craig; Chase, Peter; Fox, Larry A.; Ruedy, Katrina J.; Tsalikian, Eva; Weinzimer, Stuart A.; Fiallo-Scharer, Rosanna; Messer, Laurel; Tallant, Barbara; Tansey, Michael J.; Larson, Linda F.; Coffey, Julie; Cabbage, Joanne; Wysocki, Tim; Mauras, Nelly; Bird, Keisha; Englert, Kim; Buckingham, Bruce A.; Block, Jennifer M.; Clinton, Paula; Caswell, Kimberly; Doyle, Elizabeth A.; Mokotoff, Heather; Steffen, Amy; Xing, Dongyuan; Stockdale, Cynthia R.; Jackson, Judy; Steffes, Michael W.; Bucksa, Jean M.; Nowicki, Maren L.; Van Hale, Carol A.; Makky, Vicky; Grave, Gilman D.; Horlick, Mary; Teff, Karen; Winer, Karen K.; Becker, Dorothy M.; Cleary, Patricia; Ryan, Christopher M.; White, Neil H.; White, Perrin C.

In: Diabetes care, Vol. 30, No. 1, 01.01.2007, p. 59-64.

Research output: Contribution to journalArticle

Wilson, DM, Beck, RW, Tamborlane, WV, Dontchev, MJ, Kollman, C, Chase, P, Fox, LA, Ruedy, KJ, Tsalikian, E, Weinzimer, SA, Fiallo-Scharer, R, Messer, L, Tallant, B, Tansey, MJ, Larson, LF, Coffey, J, Cabbage, J, Wysocki, T, Mauras, N, Bird, K, Englert, K, Buckingham, BA, Block, JM, Clinton, P, Caswell, K, Doyle, EA, Mokotoff, H, Steffen, A, Xing, D, Stockdale, CR, Jackson, J, Steffes, MW, Bucksa, JM, Nowicki, ML, Van Hale, CA, Makky, V, Grave, GD, Horlick, M, Teff, K, Winer, KK, Becker, DM, Cleary, P, Ryan, CM, White, NH & White, PC 2007, 'The accuracy of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes', Diabetes care, vol. 30, no. 1, pp. 59-64. https://doi.org/10.2337/dc06-1407
Wilson, Darrell M. ; Beck, Roy W. ; Tamborlane, William V. ; Dontchev, Mariya J. ; Kollman, Craig ; Chase, Peter ; Fox, Larry A. ; Ruedy, Katrina J. ; Tsalikian, Eva ; Weinzimer, Stuart A. ; Fiallo-Scharer, Rosanna ; Messer, Laurel ; Tallant, Barbara ; Tansey, Michael J. ; Larson, Linda F. ; Coffey, Julie ; Cabbage, Joanne ; Wysocki, Tim ; Mauras, Nelly ; Bird, Keisha ; Englert, Kim ; Buckingham, Bruce A. ; Block, Jennifer M. ; Clinton, Paula ; Caswell, Kimberly ; Doyle, Elizabeth A. ; Mokotoff, Heather ; Steffen, Amy ; Xing, Dongyuan ; Stockdale, Cynthia R. ; Jackson, Judy ; Steffes, Michael W. ; Bucksa, Jean M. ; Nowicki, Maren L. ; Van Hale, Carol A. ; Makky, Vicky ; Grave, Gilman D. ; Horlick, Mary ; Teff, Karen ; Winer, Karen K. ; Becker, Dorothy M. ; Cleary, Patricia ; Ryan, Christopher M. ; White, Neil H. ; White, Perrin C. / The accuracy of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes. In: Diabetes care. 2007 ; Vol. 30, No. 1. pp. 59-64.
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abstract = "OBJECTIVE - To evaluate the accuracy and precision of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes. RESEARCH DESIGN AND METHODS - In 30 children with type 1 diabetes (mean age 11.2 ± 4.1 years), the Navigator glucose values were compared with reference serum glucose values of blood samples obtained in an inpatient clinical research center and measured in a central laboratory using a hexokinase enzymatic method and in an outpatient setting with a FreeStyle meter. Median absolute difference (AD) and median relative absolute difference (RAD) were computed for sensor-reference and sensor-sensor pairs. RESULTS - The median AD and RAD were 17 mg/dl and 12{\%}, respectively, for 1,811 inpatient sensor-reference pairs and 20 mg/dl and 14{\%}, respectively, for 8,639 outpatient pairs. The median RAD between two simultaneous Navigator measurements (n = 1,971) was 13{\%}. Ninety-one percent of sensors in the inpatient setting and 81{\%} of sensors in the outpatient setting had a median RAD ≤20{\%}. CONCLUSIONS - The Navigator's accuracy does not yet approach the accuracy of current-generation home glucose meters, but it is sufficient to believe that the device has the potential to be an important adjunct to treatment of youth with type 1 diabetes.",
author = "Wilson, {Darrell M.} and Beck, {Roy W.} and Tamborlane, {William V.} and Dontchev, {Mariya J.} and Craig Kollman and Peter Chase and Fox, {Larry A.} and Ruedy, {Katrina J.} and Eva Tsalikian and Weinzimer, {Stuart A.} and Rosanna Fiallo-Scharer and Laurel Messer and Barbara Tallant and Tansey, {Michael J.} and Larson, {Linda F.} and Julie Coffey and Joanne Cabbage and Tim Wysocki and Nelly Mauras and Keisha Bird and Kim Englert and Buckingham, {Bruce A.} and Block, {Jennifer M.} and Paula Clinton and Kimberly Caswell and Doyle, {Elizabeth A.} and Heather Mokotoff and Amy Steffen and Dongyuan Xing and Stockdale, {Cynthia R.} and Judy Jackson and Steffes, {Michael W.} and Bucksa, {Jean M.} and Nowicki, {Maren L.} and {Van Hale}, {Carol A.} and Vicky Makky and Grave, {Gilman D.} and Mary Horlick and Karen Teff and Winer, {Karen K.} and Becker, {Dorothy M.} and Patricia Cleary and Ryan, {Christopher M.} and White, {Neil H.} and White, {Perrin C.}",
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T1 - The accuracy of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes

AU - Wilson, Darrell M.

AU - Beck, Roy W.

AU - Tamborlane, William V.

AU - Dontchev, Mariya J.

AU - Kollman, Craig

AU - Chase, Peter

AU - Fox, Larry A.

AU - Ruedy, Katrina J.

AU - Tsalikian, Eva

AU - Weinzimer, Stuart A.

AU - Fiallo-Scharer, Rosanna

AU - Messer, Laurel

AU - Tallant, Barbara

AU - Tansey, Michael J.

AU - Larson, Linda F.

AU - Coffey, Julie

AU - Cabbage, Joanne

AU - Wysocki, Tim

AU - Mauras, Nelly

AU - Bird, Keisha

AU - Englert, Kim

AU - Buckingham, Bruce A.

AU - Block, Jennifer M.

AU - Clinton, Paula

AU - Caswell, Kimberly

AU - Doyle, Elizabeth A.

AU - Mokotoff, Heather

AU - Steffen, Amy

AU - Xing, Dongyuan

AU - Stockdale, Cynthia R.

AU - Jackson, Judy

AU - Steffes, Michael W.

AU - Bucksa, Jean M.

AU - Nowicki, Maren L.

AU - Van Hale, Carol A.

AU - Makky, Vicky

AU - Grave, Gilman D.

AU - Horlick, Mary

AU - Teff, Karen

AU - Winer, Karen K.

AU - Becker, Dorothy M.

AU - Cleary, Patricia

AU - Ryan, Christopher M.

AU - White, Neil H.

AU - White, Perrin C.

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Y1 - 2007/1/1

N2 - OBJECTIVE - To evaluate the accuracy and precision of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes. RESEARCH DESIGN AND METHODS - In 30 children with type 1 diabetes (mean age 11.2 ± 4.1 years), the Navigator glucose values were compared with reference serum glucose values of blood samples obtained in an inpatient clinical research center and measured in a central laboratory using a hexokinase enzymatic method and in an outpatient setting with a FreeStyle meter. Median absolute difference (AD) and median relative absolute difference (RAD) were computed for sensor-reference and sensor-sensor pairs. RESULTS - The median AD and RAD were 17 mg/dl and 12%, respectively, for 1,811 inpatient sensor-reference pairs and 20 mg/dl and 14%, respectively, for 8,639 outpatient pairs. The median RAD between two simultaneous Navigator measurements (n = 1,971) was 13%. Ninety-one percent of sensors in the inpatient setting and 81% of sensors in the outpatient setting had a median RAD ≤20%. CONCLUSIONS - The Navigator's accuracy does not yet approach the accuracy of current-generation home glucose meters, but it is sufficient to believe that the device has the potential to be an important adjunct to treatment of youth with type 1 diabetes.

AB - OBJECTIVE - To evaluate the accuracy and precision of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes. RESEARCH DESIGN AND METHODS - In 30 children with type 1 diabetes (mean age 11.2 ± 4.1 years), the Navigator glucose values were compared with reference serum glucose values of blood samples obtained in an inpatient clinical research center and measured in a central laboratory using a hexokinase enzymatic method and in an outpatient setting with a FreeStyle meter. Median absolute difference (AD) and median relative absolute difference (RAD) were computed for sensor-reference and sensor-sensor pairs. RESULTS - The median AD and RAD were 17 mg/dl and 12%, respectively, for 1,811 inpatient sensor-reference pairs and 20 mg/dl and 14%, respectively, for 8,639 outpatient pairs. The median RAD between two simultaneous Navigator measurements (n = 1,971) was 13%. Ninety-one percent of sensors in the inpatient setting and 81% of sensors in the outpatient setting had a median RAD ≤20%. CONCLUSIONS - The Navigator's accuracy does not yet approach the accuracy of current-generation home glucose meters, but it is sufficient to believe that the device has the potential to be an important adjunct to treatment of youth with type 1 diabetes.

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