Pumps or Multiple Daily Injections in Pregnancy Involving Type 1 Diabetes: A Prespecified Analysis of the CONCEPTT Randomized Trial

• Published in: Diabetes care Vol. 41; no. 12; pp. 2471 - 2479
• Main Authors: Feig, Denice S, Corcoy, Rosa, Donovan, Lois E, Murphy, Kellie E, Barrett, Jon F R, Sanchez, J Johanna, Wysocki, Tim, Ruedy, Katrina, Kollman, Craig, Tomlinson, George, Murphy, Helen R
• Format: Journal Article
• Language: English
• Published: United States American Diabetes Association 01-12-2018
• Subjects: Adolescent; Adult; Anxiety; Blood glucose; Blood Glucose - analysis; Blood Glucose - metabolism; Blood Glucose Self-Monitoring; Clinical trials; Diabetes; Diabetes mellitus; Diabetes mellitus (insulin dependent); Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 1 - drug therapy; Drug Administration Schedule; Evidence-based medicine; Female; Gestation; Glucose; Glucose monitoring; Glycated Hemoglobin A - analysis; Glycated Hemoglobin A - metabolism; Humans; Hypertension; Hypoglycemia; Infant, Newborn; Injections, Subcutaneous; Insulin; Insulin - administration & dosage; Insulin - adverse effects; Insulin Infusion Systems; Neonates; Pregnancy; Pregnancy Complications - blood; Pregnancy Complications - drug therapy; Pregnancy Outcome; Pumps; Quality of Life; Research design; Smoke; Therapy; Treatment Outcome; Vitamins; Young Adult
• ISSN: 0149-5992; 1935-5548
• DOI: 10.2337/dc18-1437

To compare glycemic control, quality of life, and pregnancy outcomes of women using insulin pumps and multiple daily injection therapy (MDI) during the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT).
This was a prespecified analysis of CONCEPTT involving 248 pregnant women from 31 centers. Randomization was stratified for pump versus MDI and HbA
. The primary outcome was change in HbA
from randomization to 34 weeks' gestation. Key secondary outcomes were continuous glucose monitoring (CGM) measures, maternal-infant health, and patient-reported outcomes.
At baseline, pump users were more often in stable relationships (
= 0.003), more likely to take preconception vitamins (
= 0.03), and less likely to smoke (
= 0.02). Pump and MDI users had comparable first-trimester glycemia: HbA
6.84 ± 0.71 vs. 6.95 ± 0.58% (51 ± 7.8 vs. 52 ± 6.3 mmol/mol) (
= 0.31) and CGM time in target (51 ± 14 vs. 50 ± 13%) (
= 0.40). At 34 weeks, MDI users had a greater decrease in HbA
(-0.55 ± 0.59 vs. -0.32 ± 0.65%,
= 0.001). At 24 and 34 weeks, MDI users were more likely to achieve target HbA
(
= 0.009 and
= 0.001, respectively). Pump users had more hypertensive disorders (
= 0.011), mainly driven by increased gestational hypertension (14.4 vs. 5.2%;
= 0.025), and more neonatal hypoglycemia (31.8 vs. 19.1%,
= 0.05) and neonatal intensive care unit (NICU) admissions >24 h (44.5 vs. 29.6%;
= 0.02). Pump users had a larger reduction in hypoglycemia-related anxiety (
= 0.05) but greater decline in health/well-being (
= 0.02).
In CONCEPTT, MDI users were more likely to have better glycemic outcomes and less likely to have gestational hypertension, neonatal hypoglycemia, and NICU admissions than pump users. These data suggest that implementation of insulin pump therapy is potentially suboptimal during pregnancy.