Continuous Glucose Monitoring Time-in-Range and HbA1c Targets in Pregnant Women with Type 1 Diabetes

Diana Tundidor, Claire L Meek, Jennifer Yamamoto, Cecilia Martínez-Bru, Ignasi Gich, Denice S Feig, Helen R Murphy, Rosa Corcoy, CONCEPTT Collaborative Group, Helen Murphy, Jeannie Grisoni, Carolyn Byrne, Sandra Neoh, Katy Davenport, Lois Donovan, Claire Gougeon, Carolyn Oldford, Catherine Young, Stephanie Amiel, Katharine Hunt, Louisa Green, Helen Rogers, Benedetta Rossi, Denice Feig, Barbara Cleave, Michelle Strom, Alberto de Leiva, Juan María Adelantado, Ana Isabel Chico, Erin Keely, Janine Malcolm, Kathy Henry, Damian Morris, Gerry Rayman, Duncan Fowler, Susan Mitchell, Josephine Rosier, Rosemary Temple, Jeremy Turner, Gioia Canciani, Niranjala Hewapathirana, Leanne Piper, Ruth McManus, Anne Kudirka, Margaret Watson, Matteo Bonomo, Basilio Pintaudi, Federico Bertuzzi, Giuseppina Daniela Corica, Elena Mion, Julia Lowe, Ilana Halperin, Anna Rogowsky, Sapida Adib, Robert Lindsay, David Carty, Isobel Crawford, Fiona Mackenzie, Therese McSorley, John Booth, Natalia McInnes, Ada Smith, Irene Stanton, Tracy Tazzeo, John Weisnagel, Peter Mansell, Nia Jones, Gayna Babington, Dawn Spick, Malcolm MacDougall, Sharon Chilton, Terri Cutts, Michelle Perkins, Eleanor Scott, Del Endersby, Anna Dover, Frances Dougherty, Susan Johnston, Simon Heller, Peter Novodorsky, Sue Hudson, Chloe Nisbet, Thomas Ransom, Jill Coolen, Darlene Baxendale, Richard Holt, Jane Forbes, Nicki Martin, Fiona Walbridge, Fidelma Dunne, Sharon Conway, Aoife Egan, Collette Kirwin, Michael Maresh, Gretta Kearney, Juliet Morris, Susan Quinn, Rudy Bilous, Rasha Mukhtar, Ariane Godbout, Sylvie Daigle, Alexandra Lubina Solomon, Margaret Jackson, Emma Paul, Julie Taylor, Robyn Houlden, Adriana Breen, Anita Banerjee, Anna Brackenridge, Annette Briley, Anna Reid, Claire Singh, Jill Newstead Angel, Janet Baxter, Sam Philip, Martyna Chlost, Lynne Murray, Kristin Castorino, Lois Jovanovic, Donna Frase, Sonya Mergler, Kathryn Mangoff, Johanna Sanchez, Gail Klein, Katrina Ruedy, Craig Kollman, Olivia Lou, Marlon Pragnell, Diana Tundidor, Claire L Meek, Jennifer Yamamoto, Cecilia Martínez-Bru, Ignasi Gich, Denice S Feig, Helen R Murphy, Rosa Corcoy, CONCEPTT Collaborative Group, Helen Murphy, Jeannie Grisoni, Carolyn Byrne, Sandra Neoh, Katy Davenport, Lois Donovan, Claire Gougeon, Carolyn Oldford, Catherine Young, Stephanie Amiel, Katharine Hunt, Louisa Green, Helen Rogers, Benedetta Rossi, Denice Feig, Barbara Cleave, Michelle Strom, Alberto de Leiva, Juan María Adelantado, Ana Isabel Chico, Erin Keely, Janine Malcolm, Kathy Henry, Damian Morris, Gerry Rayman, Duncan Fowler, Susan Mitchell, Josephine Rosier, Rosemary Temple, Jeremy Turner, Gioia Canciani, Niranjala Hewapathirana, Leanne Piper, Ruth McManus, Anne Kudirka, Margaret Watson, Matteo Bonomo, Basilio Pintaudi, Federico Bertuzzi, Giuseppina Daniela Corica, Elena Mion, Julia Lowe, Ilana Halperin, Anna Rogowsky, Sapida Adib, Robert Lindsay, David Carty, Isobel Crawford, Fiona Mackenzie, Therese McSorley, John Booth, Natalia McInnes, Ada Smith, Irene Stanton, Tracy Tazzeo, John Weisnagel, Peter Mansell, Nia Jones, Gayna Babington, Dawn Spick, Malcolm MacDougall, Sharon Chilton, Terri Cutts, Michelle Perkins, Eleanor Scott, Del Endersby, Anna Dover, Frances Dougherty, Susan Johnston, Simon Heller, Peter Novodorsky, Sue Hudson, Chloe Nisbet, Thomas Ransom, Jill Coolen, Darlene Baxendale, Richard Holt, Jane Forbes, Nicki Martin, Fiona Walbridge, Fidelma Dunne, Sharon Conway, Aoife Egan, Collette Kirwin, Michael Maresh, Gretta Kearney, Juliet Morris, Susan Quinn, Rudy Bilous, Rasha Mukhtar, Ariane Godbout, Sylvie Daigle, Alexandra Lubina Solomon, Margaret Jackson, Emma Paul, Julie Taylor, Robyn Houlden, Adriana Breen, Anita Banerjee, Anna Brackenridge, Annette Briley, Anna Reid, Claire Singh, Jill Newstead Angel, Janet Baxter, Sam Philip, Martyna Chlost, Lynne Murray, Kristin Castorino, Lois Jovanovic, Donna Frase, Sonya Mergler, Kathryn Mangoff, Johanna Sanchez, Gail Klein, Katrina Ruedy, Craig Kollman, Olivia Lou, Marlon Pragnell

Abstract

The CONCEPTT trial compared real-time Continuous Glucose Monitoring (RT-CGM) to capillary glucose monitoring in pregnant women with type 1 diabetes. We analyzed CGM and glycated hemoglobin (HbA1c) measures in first (n = 221), second (n = 197), and third (n = 172) trimesters, aiming to examine target glucose attainment and associations with pregnancy outcomes. CGM targets were Time-in-range (TIR) > 70%, Time-above-range (TAR) <25%, and Time-below-range (TBR) < 4%, and HbA1c targets < 6.5% (National Institute for Health and Care Excellence [NICE]) and HbA1c < 6.0% in second and third trimesters (American Diabetes Association [ADA]). TIR/TAR/TBR targets were achieved by 7.7/14.5/30.3% participants in first, 10.2/14.2/52.8% in second, and 35.5/37.2/52.9% in third trimesters. CGM target attainment was low but increased during pregnancy and with RT-CGM use. In the adjusted analyses, achieving TBR target was associated with a higher risk of pre-eclampsia and neonatal hypoglycemia. ADA HbA1c target attainment was low and unchanged during pregnancy (23.5/27.9/23.8%) but increased with RT-CGM use. In the adjusted analyses, HbA1c target attainment was associated with a lower risk of preterm birth, large-for-gestational age and neonatal hypoglycemia. We conclude that CONCEPTT trial participants had a low rate of CGM and of HbA1c target attainment. Attainment of CGM and NICE HbA1c targets increased throughout gestation and all targets (both NICE/ADA HbA1c and CGM) were more likely to be achieved by RT-CGM users, at 34 weeks' gestation. ADA HbA1c target achievement was independently associated with better perinatal outcomes, while the independent association of TBR target achievement with increased risk warrants further study. ClinicalTrials.gov Registration Identifier NCT01788527.

Keywords: Continuous glucose monitoring; HbA1c target; Pregnancy; Time-in-range; Type 1 diabetes.

Conflict of interest statement

D.T., C.L.M., J.Y., C.M.-B., and I.G. have no relevant conflicts of interest to report. D.S.F. has received honoraria for speaking engagements from Medtronic and has been on an advisory board for Novo Nordisk. H.R.M. has received honoraria for speaking engagements from Medtronic, Roche, Novo Nordisk, and Eli Lilly and is a member of the Medtronic European Advisory Board. R.C. has received honoraria for speaking engagements with Eli Lilly and Novo Nordisk and has been on an advisory boards for Novo Nordisk and Abbott.

Figures

FIG. 1.
FIG. 1.
CGM-based TIR and HbA1c in pregnant women included in the subanalysis. The diagram displays average TIR, TAR, TBR, and HbA1c in each trimester for RT-CGM and control arms combined. P-values for change over time were P < 0.001 for TAR, P < 0.001 for TIR, P < 0.001 for TBR, and P < 0.001 for HbA1c. CGM, continuous glucose monitoring; HbA1c, glycated hemoglobin; RT-CGM, real-time CGM; TAR, Time-above-range; TBR, Time-below-range; TIR, Time-in-range. Color graphics appear online.

Source: PubMed

3
Předplatit