TY - JOUR
T1 - Longitudinal Observation of Insulin Use and Glucose Sensor Metrics in Pregnant Women with Type 1 Diabetes Using Continuous Glucose Monitors and Insulin Pumps
T2 - The LOIS-P Study
AU - O'Malley, Grenye
AU - Ozaslan, Basak
AU - Levy, Carol J.
AU - Castorino, Kristin
AU - Desjardins, Donna
AU - Levister, Camilla
AU - McCrady-Spitzer, Shelly
AU - Church, Mei Mei
AU - Kaur, Ravinder Jeet
AU - Reid, Corey
AU - Kremers, Walter K.
AU - Doyle, Francis J.
AU - Trinidad, Mari Charisse
AU - Rosenn, Barak
AU - Pinsker, Jordan E.
AU - Kudva, Yogish C.
AU - Dassau, Eyal
N1 - Funding Information:
G.O. receives research support from Tandem Diabetes, Insulet, Dexcom, and Abbot. C.J.L. has received research support from Insulet, Abbott Diabetes, Tandem Diabetes and Dexcom paid to her institution, and has received consulting fees from Dexcom and Eli Lilly. K.C. receives research support provided to her institution from Dexcom, Abbott, Medtronic and Novonordisk. J.E.P. reports receiving grant support, provided to his institution, and consulting fees and speaker fees from Tandem Diabetes Care; grant support, provided to his institution, and advisory board fees from Medtronic; grant support, provided to his institution, and consulting fees from Eli Lilly; grant support and supplies, provided to his institution from Insulet; and supplies, provided to his institution from Dexcom. WKK receives research funding from the NIH, DOD, AstraZeneca, Roche, and Biogen, all unrelated to this study. Y.C.K. reports product support from Roche Diabetes, Dexcom, Tandem Diabetes, and consulting fees from Novo Nordisk. C.M.L. receives research support from Tandem Diabetes, Insulet, Dexcom, and Abbot. F.J.D. reports equity, licensed IP, and is a member of the Scientific Advisory Board of Mode AGC. E.D. reports receiving grants from JDRF, NIH, and Helmsley Charitable Trust, personal fees from Roche and Eli Lilly, patents on artificial pancreas technology, and product support from Dexcom, Insulet, Tandem, and Roche. E.D. is currently an employee and shareholder of Eli Lilly and Company. The work presented in this article was performed as part of his academic appointment and is independent of his employment with Eli Lilly and Company. No other conflict of interest was reported.
Funding Information:
The work of the LOIS-P Diabetes and Pregnancy Consortium is dedicated to the memory of Dr. Lois Jovanovi≤c, a pioneer in the field of diabetes and pregnancy, a tireless advocate for her patients, and a mentor to many of the coauthors. Statistical support was provided by Byron Smith, Mayo Clinic, and data science specialist Steven Worthington, at the Institute for Quantitative Social Science, Harvard University.
Funding Information:
REDCap data management was supported by the Research Computing Facility grant (UL1TR002377). Financial support for this study was provided by the National Institutes of Health (R01DK120358). Product support was provided by Dexcom, Inc., (AP-2018-016).
Publisher Copyright:
© Copyright 2021, Mary Ann Liebert, Inc., publishers 2021.
PY - 2021/12
Y1 - 2021/12
N2 - Background: Suboptimal glycemic control is associated with maternal and neonatal morbidity and mortality in pregnancy complicated by type 1 diabetes (T1D). Prospective analysis of continuous glucose monitoring (CGM) metrics, insulin pump settings, and insulin delivery can better characterize the changes in glycemic levels and insulin use throughout pregnancy with T1D. Materials and Methods: Prescribed parameters, insulin delivery, carbohydrate intake, and CGM data for 25 pregnant women with T1D from three U.S. sites were collected. Participants enrolled before 17 weeks gestation and used personal insulin pumps and study CGM. Mean daily total, basal, and bolus insulin doses (units/kg), CGM time in range (TIR: 63-140 mg/dL), and pump-entered carbohydrates were analyzed for every 2-week gestational interval. Linear mixed-effects regression models were used to evaluate changes across gestational ages compared to 12-14 weeks. Results: Basal insulin was higher during weeks 6-12 and 24-40. Daily bolus and total insulin were higher during weeks 20-40. Pump parameters were adjusted to intensify insulin therapy from 22 weeks onward. Average TIR across pregnancy was 59% ± 14%. Between 18 and 30 weeks, TIR was significantly lower, and time above range was significantly higher compared to the reference biweek. Time below target was lower between 22 and 34 weeks. Seven participants achieved >70% recommended TIR for pregnancy. Participants with maternal complications or infant neonatal intensive care unit admissions had lower TIR. Conclusion: While insulin dosing changed significantly with advancing gestation, most participants did not achieve >70% TIR. Customized anticipatory pump setting adjustments and automated systems aimed toward the designated TIR are needed to improve outcomes for this population.
AB - Background: Suboptimal glycemic control is associated with maternal and neonatal morbidity and mortality in pregnancy complicated by type 1 diabetes (T1D). Prospective analysis of continuous glucose monitoring (CGM) metrics, insulin pump settings, and insulin delivery can better characterize the changes in glycemic levels and insulin use throughout pregnancy with T1D. Materials and Methods: Prescribed parameters, insulin delivery, carbohydrate intake, and CGM data for 25 pregnant women with T1D from three U.S. sites were collected. Participants enrolled before 17 weeks gestation and used personal insulin pumps and study CGM. Mean daily total, basal, and bolus insulin doses (units/kg), CGM time in range (TIR: 63-140 mg/dL), and pump-entered carbohydrates were analyzed for every 2-week gestational interval. Linear mixed-effects regression models were used to evaluate changes across gestational ages compared to 12-14 weeks. Results: Basal insulin was higher during weeks 6-12 and 24-40. Daily bolus and total insulin were higher during weeks 20-40. Pump parameters were adjusted to intensify insulin therapy from 22 weeks onward. Average TIR across pregnancy was 59% ± 14%. Between 18 and 30 weeks, TIR was significantly lower, and time above range was significantly higher compared to the reference biweek. Time below target was lower between 22 and 34 weeks. Seven participants achieved >70% recommended TIR for pregnancy. Participants with maternal complications or infant neonatal intensive care unit admissions had lower TIR. Conclusion: While insulin dosing changed significantly with advancing gestation, most participants did not achieve >70% TIR. Customized anticipatory pump setting adjustments and automated systems aimed toward the designated TIR are needed to improve outcomes for this population.
KW - Continuous glucose monitoring
KW - Insulin pump therapy
KW - Pregnancy
KW - Type 1 diabetes
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UR - http://www.scopus.com/inward/citedby.url?scp=85118728158&partnerID=8YFLogxK
U2 - 10.1089/dia.2021.0112
DO - 10.1089/dia.2021.0112
M3 - Article
C2 - 34270347
AN - SCOPUS:85118728158
VL - 23
SP - 807
EP - 817
JO - Diabetes Technology and Therapeutics
JF - Diabetes Technology and Therapeutics
SN - 1520-9156
IS - 12
ER -