A Randomized Clinical Trial Assessing Continuous Glucose Monitoring (CGM) Use With Standardized Education With or Without a Family Behavioral Intervention Compared With Fingerstick Blood Glucose Monitoring in Very Young Children With Type 1 Diabetes
Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study Group, Lori Laffel, Kara Harrington, Anat Hanono, Nisha Naik, Louise Ambler-Osborn, Alan Schultz, Linda DiMeglio, Stephanie Woerne, Heather Jolivette, Heba Ismail, Megan Tebbe, America Newman, Megan Legge, William Tamborlane, Michelle Van Name, Kate Weyman, Jennifer Finnegan, Amy Steffen, Melinda Zgorski, Daniel DeSalvo, Marisa Hilliard, Kylie DeLaO, Cicilyn Xie, Wendy Levy, R Paul Wadwa, Greg Forlenza, Shideh Majidi, Guy Alonso, Isabel Weber, Michelle Clay, Emily Simmons, Brandon Nathan, Muna Sunni, Jessica Sweet, Beth Pappenfus, Anne Kogler, Marrissa Ludwig, Brittney Nelson, Anne Street, Darcy Weingartner, Anastasia Albanese-O'Neill, Michael Haller, Janey Adams, Miriam Cintron, Nicole Thomas, Jennifer Kelley, Jill Simmons, George William, Faith Brendle, Robin Goland, Kristen Williams, Rachelle Gandica, Sarah Pollak, Emily Casciano, Elizabeth Robinson, Steven Willi, Pantea Minnock, Diana Olivos, Cathy Carchidi, Brian Grant, Jenise C Wong, Saleh Adi, Sarah Corathers, Nicole Sheanon, Cathy Fox, Tammy Weis, Sarah MacLeish, Jamie Wood, Terri Casey, Wendy Campbell, Paul McGuigan, Kupper Wintergerst, Sara Watson, Suzanne Kingery, Gwen Pierce, Heather Ruch, Lauren Rayborn, Manuel Rodriguez-Luna, Amy Deuser, Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study Group, Lori Laffel, Kara Harrington, Anat Hanono, Nisha Naik, Louise Ambler-Osborn, Alan Schultz, Linda DiMeglio, Stephanie Woerne, Heather Jolivette, Heba Ismail, Megan Tebbe, America Newman, Megan Legge, William Tamborlane, Michelle Van Name, Kate Weyman, Jennifer Finnegan, Amy Steffen, Melinda Zgorski, Daniel DeSalvo, Marisa Hilliard, Kylie DeLaO, Cicilyn Xie, Wendy Levy, R Paul Wadwa, Greg Forlenza, Shideh Majidi, Guy Alonso, Isabel Weber, Michelle Clay, Emily Simmons, Brandon Nathan, Muna Sunni, Jessica Sweet, Beth Pappenfus, Anne Kogler, Marrissa Ludwig, Brittney Nelson, Anne Street, Darcy Weingartner, Anastasia Albanese-O'Neill, Michael Haller, Janey Adams, Miriam Cintron, Nicole Thomas, Jennifer Kelley, Jill Simmons, George William, Faith Brendle, Robin Goland, Kristen Williams, Rachelle Gandica, Sarah Pollak, Emily Casciano, Elizabeth Robinson, Steven Willi, Pantea Minnock, Diana Olivos, Cathy Carchidi, Brian Grant, Jenise C Wong, Saleh Adi, Sarah Corathers, Nicole Sheanon, Cathy Fox, Tammy Weis, Sarah MacLeish, Jamie Wood, Terri Casey, Wendy Campbell, Paul McGuigan, Kupper Wintergerst, Sara Watson, Suzanne Kingery, Gwen Pierce, Heather Ruch, Lauren Rayborn, Manuel Rodriguez-Luna, Amy Deuser
Abstract
Objective: This study evaluated the effects of continuous glucose monitoring (CGM) combined with family behavioral intervention (CGM+FBI) and CGM alone (Standard-CGM) on glycemic outcomes and parental quality of life compared with blood glucose monitoring (BGM) in children ages 2 to <8 years with type 1 diabetes.
Research design and methods: This was a multicenter (N = 14), 6-month, randomized controlled trial including 143 youth 2 to <8 years of age with type 1 diabetes. Primary analysis included treatment group comparisons of percent time in range (TIR) (70-180 mg/dL) across follow-up visits.
Results: Approximately 90% of participants in the CGM groups used CGM ≥6 days/week at 6 months. Between-group TIR comparisons showed no significant changes: CGM+FBI vs. BGM 3.2% (95% CI -0.5, 7.0), Standard-CGM vs. BGM 0.5% (-2.6 to 3.6), CGM+FBI vs. Standard-CGM 2.7% (-0.6, 6.1). Mean time with glucose level <70 mg/dL was reduced from baseline to follow-up in the CGM+FBI (from 5.2% to 2.6%) and Standard-CGM (5.8% to 2.5%) groups, compared with 5.4% to 5.8% with BGM (CGM+FBI vs. BGM, P < 0.001, and Standard-CGM vs. BGM, P < 0.001). No severe hypoglycemic events occurred in the CGM+FBI group, one occurred in the Standard-CGM group, and five occurred in the BGM group. CGM+FBI parents reported greater reductions in diabetes burden and fear of hypoglycemia compared with Standard-CGM (P = 0.008 and 0.04) and BGM (P = 0.02 and 0.002).
Conclusions: CGM used consistently over a 6-month period in young children with type 1 diabetes did not improve TIR but did significantly reduce time in hypoglycemia. The FBI benefited parental well-being.
Trial registration: ClinicalTrials.gov NCT02912728.
© 2020 by the American Diabetes Association.
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Source: PubMed