A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years

Nelly Mauras, Roy Beck, Dongyuan Xing, Katrina Ruedy, Bruce Buckingham, Michael Tansey, Neil H. White, Stuart A. Weinzimer, William Tamborlane, Craig Kollman, Eva Tsalikian, Michael J. Tansey, Julie Coffey, Joanne Cabbage, Sara Salamati, Larry A. Fox, Kim Englert, Joe Permuy, Kaitlin Sikes, Bruce A. BuckinghamDarrell M. Wilson, Paula Clinton, Kimberly Caswell, William V. Tamborlane, Jennifer Sherr, Amy Steffen, Kate Weyman, Melinda Zgorski, Eileen Tichy, Ana Maria Arbelaez, Lucy Levandoski, Angie Starnes, Roy W. Beck, Katrina J. Ruedy, Callyn Hall, Beth Stevens, Gilman D. Grave, Karen K. Winer, Ellen Leschek, Mark Sperling, Dorothy M. Becker, Patricia Cleary, Carla Greenbaum, Antoinette Moran, Michael W. Steffes, Jean M. Bucksa, Maren L. Nowicki, Vicky Makky

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Abstract

OBJECTIVE - Continuous glucose monitoring (CGM) has been demonstrated to improve glycemic control in adults with type 1 diabetes but less so in children. We designed a study to assess CGM benefit in young children aged 4 to 9 years with type 1 diabetes. RESEARCH DESIGN AND METHODS - After a run-in phase, 146 children with type 1 diabetes (mean age 7.5 ± 1.7 years, 64% on pumps, median diabetes duration 3.5 years) were randomly assigned to CGM or to usual care. The primary outcome was reduction in HbA 1c at 26 weeks by ≥0.5% without the occurrence of severe hypoglycemia. RESULTS - The primary outcome was achieved by 19% in the CGM group and 28% in the control group (P = 0.17). Mean change in HbA 1c was -0.1% in each group (P = 0.79). Severe hypoglycemia rates were similarly low in both groups. CGM wear decreased over time, with only 41% averaging at least 6 days/week at 26 weeks. There was no correlation between CGM use and change in HbA 1c (r s = -0.09, P = 0.44). CGM wear was well tolerated, and parental satisfaction with CGM was high. However, parental fear of hypoglycemia was not reduced. CONCLUSIONS - CGM in 4- to 9-year-olds did not improve glycemic control despite a high degree of parental satisfaction with CGM. We postulate that this finding may be related in part to limited use of the CGM glucose data in day-to-day management and to an unremitting fear of hypoglycemia. Overcoming the barriers that prevent integration of these critical glucose data into day-to-day management remains a challenge.

Original languageEnglish (US)
Pages (from-to)204-210
Number of pages7
JournalDiabetes care
Volume35
Issue number2
DOIs
StatePublished - Feb 1 2012

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Type 1 Diabetes Mellitus
Randomized Controlled Trials
Safety
Glucose
Hypoglycemia
Fear
Research Design

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A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years. / Mauras, Nelly; Beck, Roy; Xing, Dongyuan; Ruedy, Katrina; Buckingham, Bruce; Tansey, Michael; White, Neil H.; Weinzimer, Stuart A.; Tamborlane, William; Kollman, Craig; Tsalikian, Eva; Tansey, Michael J.; Coffey, Julie; Cabbage, Joanne; Salamati, Sara; Fox, Larry A.; Englert, Kim; Permuy, Joe; Sikes, Kaitlin; Buckingham, Bruce A.; Wilson, Darrell M.; Clinton, Paula; Caswell, Kimberly; Tamborlane, William V.; Sherr, Jennifer; Steffen, Amy; Weyman, Kate; Zgorski, Melinda; Tichy, Eileen; Arbelaez, Ana Maria; Levandoski, Lucy; Starnes, Angie; Beck, Roy W.; Ruedy, Katrina J.; Hall, Callyn; Stevens, Beth; Grave, Gilman D.; Winer, Karen K.; Leschek, Ellen; Sperling, Mark; Becker, Dorothy M.; Cleary, Patricia; Greenbaum, Carla; Moran, Antoinette; Steffes, Michael W.; Bucksa, Jean M.; Nowicki, Maren L.; Makky, Vicky.

In: Diabetes care, Vol. 35, No. 2, 01.02.2012, p. 204-210.

Research output: Contribution to journalArticle

Mauras, N, Beck, R, Xing, D, Ruedy, K, Buckingham, B, Tansey, M, White, NH, Weinzimer, SA, Tamborlane, W, Kollman, C, Tsalikian, E, Tansey, MJ, Coffey, J, Cabbage, J, Salamati, S, Fox, LA, Englert, K, Permuy, J, Sikes, K, Buckingham, BA, Wilson, DM, Clinton, P, Caswell, K, Tamborlane, WV, Sherr, J, Steffen, A, Weyman, K, Zgorski, M, Tichy, E, Arbelaez, AM, Levandoski, L, Starnes, A, Beck, RW, Ruedy, KJ, Hall, C, Stevens, B, Grave, GD, Winer, KK, Leschek, E, Sperling, M, Becker, DM, Cleary, P, Greenbaum, C, Moran, A, Steffes, MW, Bucksa, JM, Nowicki, ML & Makky, V 2012, 'A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years', Diabetes care, vol. 35, no. 2, pp. 204-210. https://doi.org/10.2337/dc11-1746
Mauras, Nelly ; Beck, Roy ; Xing, Dongyuan ; Ruedy, Katrina ; Buckingham, Bruce ; Tansey, Michael ; White, Neil H. ; Weinzimer, Stuart A. ; Tamborlane, William ; Kollman, Craig ; Tsalikian, Eva ; Tansey, Michael J. ; Coffey, Julie ; Cabbage, Joanne ; Salamati, Sara ; Fox, Larry A. ; Englert, Kim ; Permuy, Joe ; Sikes, Kaitlin ; Buckingham, Bruce A. ; Wilson, Darrell M. ; Clinton, Paula ; Caswell, Kimberly ; Tamborlane, William V. ; Sherr, Jennifer ; Steffen, Amy ; Weyman, Kate ; Zgorski, Melinda ; Tichy, Eileen ; Arbelaez, Ana Maria ; Levandoski, Lucy ; Starnes, Angie ; Beck, Roy W. ; Ruedy, Katrina J. ; Hall, Callyn ; Stevens, Beth ; Grave, Gilman D. ; Winer, Karen K. ; Leschek, Ellen ; Sperling, Mark ; Becker, Dorothy M. ; Cleary, Patricia ; Greenbaum, Carla ; Moran, Antoinette ; Steffes, Michael W. ; Bucksa, Jean M. ; Nowicki, Maren L. ; Makky, Vicky. / A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years. In: Diabetes care. 2012 ; Vol. 35, No. 2. pp. 204-210.
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title = "A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years",
abstract = "OBJECTIVE - Continuous glucose monitoring (CGM) has been demonstrated to improve glycemic control in adults with type 1 diabetes but less so in children. We designed a study to assess CGM benefit in young children aged 4 to 9 years with type 1 diabetes. RESEARCH DESIGN AND METHODS - After a run-in phase, 146 children with type 1 diabetes (mean age 7.5 ± 1.7 years, 64{\%} on pumps, median diabetes duration 3.5 years) were randomly assigned to CGM or to usual care. The primary outcome was reduction in HbA 1c at 26 weeks by ≥0.5{\%} without the occurrence of severe hypoglycemia. RESULTS - The primary outcome was achieved by 19{\%} in the CGM group and 28{\%} in the control group (P = 0.17). Mean change in HbA 1c was -0.1{\%} in each group (P = 0.79). Severe hypoglycemia rates were similarly low in both groups. CGM wear decreased over time, with only 41{\%} averaging at least 6 days/week at 26 weeks. There was no correlation between CGM use and change in HbA 1c (r s = -0.09, P = 0.44). CGM wear was well tolerated, and parental satisfaction with CGM was high. However, parental fear of hypoglycemia was not reduced. CONCLUSIONS - CGM in 4- to 9-year-olds did not improve glycemic control despite a high degree of parental satisfaction with CGM. We postulate that this finding may be related in part to limited use of the CGM glucose data in day-to-day management and to an unremitting fear of hypoglycemia. Overcoming the barriers that prevent integration of these critical glucose data into day-to-day management remains a challenge.",
author = "Nelly Mauras and Roy Beck and Dongyuan Xing and Katrina Ruedy and Bruce Buckingham and Michael Tansey and White, {Neil H.} and Weinzimer, {Stuart A.} and William Tamborlane and Craig Kollman and Eva Tsalikian and Tansey, {Michael J.} and Julie Coffey and Joanne Cabbage and Sara Salamati and Fox, {Larry A.} and Kim Englert and Joe Permuy and Kaitlin Sikes and Buckingham, {Bruce A.} and Wilson, {Darrell M.} and Paula Clinton and Kimberly Caswell and Tamborlane, {William V.} and Jennifer Sherr and Amy Steffen and Kate Weyman and Melinda Zgorski and Eileen Tichy and Arbelaez, {Ana Maria} and Lucy Levandoski and Angie Starnes and Beck, {Roy W.} and Ruedy, {Katrina J.} and Callyn Hall and Beth Stevens and Grave, {Gilman D.} and Winer, {Karen K.} and Ellen Leschek and Mark Sperling and Becker, {Dorothy M.} and Patricia Cleary and Carla Greenbaum and Antoinette Moran and Steffes, {Michael W.} and Bucksa, {Jean M.} and Nowicki, {Maren L.} and Vicky Makky",
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T1 - A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years

AU - Mauras, Nelly

AU - Beck, Roy

AU - Xing, Dongyuan

AU - Ruedy, Katrina

AU - Buckingham, Bruce

AU - Tansey, Michael

AU - White, Neil H.

AU - Weinzimer, Stuart A.

AU - Tamborlane, William

AU - Kollman, Craig

AU - Tsalikian, Eva

AU - Tansey, Michael J.

AU - Coffey, Julie

AU - Cabbage, Joanne

AU - Salamati, Sara

AU - Fox, Larry A.

AU - Englert, Kim

AU - Permuy, Joe

AU - Sikes, Kaitlin

AU - Buckingham, Bruce A.

AU - Wilson, Darrell M.

AU - Clinton, Paula

AU - Caswell, Kimberly

AU - Tamborlane, William V.

AU - Sherr, Jennifer

AU - Steffen, Amy

AU - Weyman, Kate

AU - Zgorski, Melinda

AU - Tichy, Eileen

AU - Arbelaez, Ana Maria

AU - Levandoski, Lucy

AU - Starnes, Angie

AU - Beck, Roy W.

AU - Ruedy, Katrina J.

AU - Hall, Callyn

AU - Stevens, Beth

AU - Grave, Gilman D.

AU - Winer, Karen K.

AU - Leschek, Ellen

AU - Sperling, Mark

AU - Becker, Dorothy M.

AU - Cleary, Patricia

AU - Greenbaum, Carla

AU - Moran, Antoinette

AU - Steffes, Michael W.

AU - Bucksa, Jean M.

AU - Nowicki, Maren L.

AU - Makky, Vicky

PY - 2012/2/1

Y1 - 2012/2/1

N2 - OBJECTIVE - Continuous glucose monitoring (CGM) has been demonstrated to improve glycemic control in adults with type 1 diabetes but less so in children. We designed a study to assess CGM benefit in young children aged 4 to 9 years with type 1 diabetes. RESEARCH DESIGN AND METHODS - After a run-in phase, 146 children with type 1 diabetes (mean age 7.5 ± 1.7 years, 64% on pumps, median diabetes duration 3.5 years) were randomly assigned to CGM or to usual care. The primary outcome was reduction in HbA 1c at 26 weeks by ≥0.5% without the occurrence of severe hypoglycemia. RESULTS - The primary outcome was achieved by 19% in the CGM group and 28% in the control group (P = 0.17). Mean change in HbA 1c was -0.1% in each group (P = 0.79). Severe hypoglycemia rates were similarly low in both groups. CGM wear decreased over time, with only 41% averaging at least 6 days/week at 26 weeks. There was no correlation between CGM use and change in HbA 1c (r s = -0.09, P = 0.44). CGM wear was well tolerated, and parental satisfaction with CGM was high. However, parental fear of hypoglycemia was not reduced. CONCLUSIONS - CGM in 4- to 9-year-olds did not improve glycemic control despite a high degree of parental satisfaction with CGM. We postulate that this finding may be related in part to limited use of the CGM glucose data in day-to-day management and to an unremitting fear of hypoglycemia. Overcoming the barriers that prevent integration of these critical glucose data into day-to-day management remains a challenge.

AB - OBJECTIVE - Continuous glucose monitoring (CGM) has been demonstrated to improve glycemic control in adults with type 1 diabetes but less so in children. We designed a study to assess CGM benefit in young children aged 4 to 9 years with type 1 diabetes. RESEARCH DESIGN AND METHODS - After a run-in phase, 146 children with type 1 diabetes (mean age 7.5 ± 1.7 years, 64% on pumps, median diabetes duration 3.5 years) were randomly assigned to CGM or to usual care. The primary outcome was reduction in HbA 1c at 26 weeks by ≥0.5% without the occurrence of severe hypoglycemia. RESULTS - The primary outcome was achieved by 19% in the CGM group and 28% in the control group (P = 0.17). Mean change in HbA 1c was -0.1% in each group (P = 0.79). Severe hypoglycemia rates were similarly low in both groups. CGM wear decreased over time, with only 41% averaging at least 6 days/week at 26 weeks. There was no correlation between CGM use and change in HbA 1c (r s = -0.09, P = 0.44). CGM wear was well tolerated, and parental satisfaction with CGM was high. However, parental fear of hypoglycemia was not reduced. CONCLUSIONS - CGM in 4- to 9-year-olds did not improve glycemic control despite a high degree of parental satisfaction with CGM. We postulate that this finding may be related in part to limited use of the CGM glucose data in day-to-day management and to an unremitting fear of hypoglycemia. Overcoming the barriers that prevent integration of these critical glucose data into day-to-day management remains a challenge.

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U2 - 10.2337/dc11-1746

DO - 10.2337/dc11-1746

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EP - 210

JO - Diabetes Care

JF - Diabetes Care

SN - 1935-5548

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