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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.
- Laffel, Lori;
- Harrington, Kara;
- Hanono, Anat;
- Naik, Nisha;
- Ambler-Osborn, Louise;
- Schultz, Alan;
- DiMeglio, Linda;
- Woerne, Stephanie;
- Jolivette, Heather;
- Ismail, Heba;
- Tebbe, Megan;
- Newman, America;
- Legge, Megan;
- Tamborlane, William;
- Van Name, Michelle;
- Weyman, Kate;
- Finnegan, Jennifer;
- Steffen, Amy;
- Zgorski, Melinda;
- DeSalvo, Daniel;
- Hilliard, Marisa;
- DeLaO, Kylie;
- Xie, Cicilyn;
- Levy, Wendy;
- Wadwa, R Paul;
- Forlenza, Greg;
- Majidi, Shideh;
- Alonso, Guy;
- Weber, Isabel;
- Clay, Michelle;
- Simmons, Emily;
- Nathan, Brandon;
- Sunni, Muna;
- Sweet, Jessica;
- Pappenfus, Beth;
- Kogler, Anne;
- Ludwig, Marrissa;
- Nelson, Brittney;
- Street, Anne;
- Weingartner, Darcy;
- Albanese-O’Neill, Anastasia;
- Haller, Michael;
- Adams, Janey;
- Cintron, Miriam;
- Thomas, Nicole;
- Kelley, Jennifer;
- Simmons, Jill;
- William, George;
- Brendle, Faith;
- Goland, Robin;
- Williams, Kristen;
- Gandica, Rachelle;
- Pollak, Sarah;
- Casciano, Emily;
- Robinson, Elizabeth;
- Willi, Steven;
- Minnock, Pantea;
- Olivos, Diana;
- Carchidi, Cathy;
- Grant, Brian;
- Wong, Jenise C;
- Adi, Saleh;
- Corathers, Sarah;
- Sheanon, Nicole;
- Fox, Cathy;
- Weis, Tammy;
- MacLeish, Sarah;
- Wood, Jamie;
- Casey, Terri;
- Campbell, Wendy;
- McGuigan, Paul;
- Wintergerst, Kupper;
- Watson, Sara;
- Kingery, Suzanne;
- Pierce, Gwen;
- Ruch, Heather;
- Rayborn, Lauren;
- Rodriguez-Luna, Manuel;
- Deuser, Amy
- et al.
Published Web Location
https://doi.org/10.2337/dc20-1060Abstract
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.Many UC-authored scholarly publications are freely available on this site because of the UC's open access policies. Let us know how this access is important for you.
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