108-LB: Randomized Trial of Automated Insulin Delivery in Pregnant Women with Type 1 Diabetes
HELEN R. MURPHY, TARA T.M. LEE, CORINNE COLLETT, SARA HARTNELL, ELEANOR M. SCOTT, ROBERT S. LINDSAY, KATHARINE F. HUNT, DAVID R. MCCANCE, MATT HAMMOND, LEE SHEPSTONE, MALGORZATA E. WILINSKA, SIMON BERGFORD, JUDY SIBAYAN, CRAIG KOLLMAN, ROY BECK, ROMAN HOVORKA- Endocrinology, Diabetes and Metabolism
- Internal Medicine
Objective: To examine the clinical efficacy of automated insulin delivery (AID) during type 1 diabetes (T1D) pregnancy.
Methods and Outcomes: We randomized pregnant women with T1D from nine UK clinical sites to hybrid closed-loop (CamAPS FX) or standard insulin therapy with continuous glucose monitoring. The primary outcome was the between-group difference in percentage time in the pregnancy-specific target glucose range (63-140mg/dl) from 16-weeks’ gestation until delivery. Analyses were performed according to intention-to-treat principles. Key secondary outcomes included overnight time-in-range (TIR), time spent hyperglycaemic (time-above-range, TAR >140mg/dl), HbA1c and safety events.
Results: 124 participants (aged 31.1 ± 5.3yrs, HbA1c 7.7 ± 1.2%, T1D duration 2-31yrs, weight 49.0-138.0kg, total daily insulin doses 0.3-1.4units/kg) were randomized. The percentage of time that maternal glucose levels were within target was higher during AID than standard insulin therapy; mean between-group treatment difference 10%; 95% CI 7 to 10%; p < 0.001. Participants randomized to AID had larger reductions in hyperglycemia (AID vs control -11%; 95% CI -14 to - 7%; p<0.001), higher overnight time-in-range; (13%; 95% CI 9 to 17%; p<0.001), and lower HbA1c (-0.34%; 95%CI -0.52 to -0.15%; p<0.001), without additional insulin, weight gain or hypoglycemia. The treatment effect was apparent from early pregnancy, consistent across clinical sites, maternal HbA1c categories and previous insulin pump or injections. A significantly higher percent of AID participants reached CGM targets (TIR >70%: 46% vs 10%; p<0.001 and TAR <25%: 37% vs 11%; p=0.007 [AID vs. control]). One neonatal death that was unrelated to standard insulin therapy occurred.
Conclusions: AID significantly improved maternal glycemia throughout T1D pregnancy. Our results support proposed NICE guideline recommendations that hybrid closed-loop therapy should be offered to all pregnant women with T1D.
Disclosure
H. R. Murphy: Advisory Panel; Medtronic, Research Support; Dexcom, Inc. L. Shepstone: None. M. E. Wilinska: Consultant; CamDiab Ltd. S. Bergford: None. J. Sibayan: None. C. Kollman: Research Support; Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc. R. Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. R. Hovorka: Advisory Panel; Ypsomed AG, Consultant; Abbott Diabetes, B. Braun, Speaker's Bureau; Eli Lilly and Company, Stock/Shareholder; CamDiab Ltd. T. T. M. Lee: None. C. Collett: None. S. Hartnell: Advisory Panel; Dexcom, Inc., Medtronic, Consultant; CamDiab Ltd., Other Relationship; AskDiabetes Ltd, Speaker's Bureau; Abbott Diabetes, Ypsomed AG. E. M. Scott: Research Support; Abbott Diabetes, Speaker's Bureau; Abbott Diabetes. R. S. Lindsay: None. K. F. Hunt: None. D. R. Mccance: None. M. Hammond: None.
Funding
National Institute for Health Research (16/35/01); JDRF (22-2013-266, 2-RSC-2019-828-M-N); Diabetes Research and Wellness Foundation (SECF/21 to T.T.M.L.)