A Randomized Trial of Closed-Loop Insulin Delivery Postpartum in Type 1 Diabetes

被引:18
作者
Donovan, Lois E. [1 ,2 ,3 ]
Feig, Denice S. [4 ,5 ,6 ]
Lemieux, Patricia [7 ]
Murphy, Helen R. [8 ]
Bell, Rhonda C. [9 ]
Sigal, Ronald J. [10 ,11 ,12 ]
Ho, Josephine [13 ,14 ]
Virtanen, Heidi [13 ,14 ]
Crawford, Susan [15 ]
Yamamoto, Jennifer M. [16 ,17 ]
机构
[1] Univ Calgary, Cumming Sch Med, Dept Med, Calgary, AB, Canada
[2] Univ Calgary, Cumming Sch Med, Dept Obstet & Gynecol, Calgary, AB, Canada
[3] Alberta Childrens Hosp Res Inst, Calgary, AB, Canada
[4] Univ Toronto, Dept Med, Toronto, ON, Canada
[5] Lunenfeld Tanenbaum Res Inst, Toronto, ON, Canada
[6] Mt Sinai Hosp, Sinai Hlth Syst, Toronto, ON, Canada
[7] Univ Laval, Dept Med, Quebec City, PQ, Canada
[8] Univ East Anglia, Norwich Med Sch, Norwich, England
[9] Univ Alberta, Li Ka Shing Ctr Hlth Res Innovat, Dept Agr Food & Nutr Sci, Div Human Nutr, Edmonton, AB, Canada
[10] Univ Calgary, Fac Med & Kinesiol, Cumming Sch Med, Dept Med, Calgary, AB, Canada
[11] Univ Calgary, Fac Med & Kinesiol, Cumming Sch Med, Dept Cardiac Sci, Calgary, AB, Canada
[12] Univ Calgary, Fac Med & Kinesiol, Cumming Sch Med, Dept Community Hlth Sci, Calgary, AB, Canada
[13] Univ Calgary, Cumming Sch Med, Dept Pediat, Calgary, AB, Canada
[14] Univ Calgary, Cumming Sch Med, Dept Endocrinol, Calgary, AB, Canada
[15] Alberta Hlth Serv, Alberta Perinatal Hlth Program, Calgary, AB, Canada
[16] Univ Manitoba, Dept Internal Med, Winnipeg, MB, Canada
[17] Childrens Hosp Res Inst Manitoba, Winnipeg, MB, Canada
关键词
PREGNANT-WOMEN;
D O I
10.2337/dc23-0882
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
OBJECTIVE This study aimed to evaluate the efficacy of closed-loop insulin delivery postpartum. RESEARCH DESIGN AND METHODS In this open-label, randomized controlled trial, postpartum individuals with type 1 diabetes were randomized to hybrid closed-loop insulin delivery with the MiniMed 670G/770G system in automode or sensor-augmented pump therapy in the first 12-weeks postpartum followed by a continuation phase with closed-loop insulin delivery for all until 24 weeks postpartum. RESULTS Eighteen participants (mean +/- SD age 32 +/- 3.5 years, diabetes duration 22 +/- 7.3 years, and early pregnancy HbA1c 52 +/- 6.8 mmol/mol [6.9 +/- 0.9%]) completed 24 weeks of postpartum follow-up. In the randomized phase, percent time in range 70-180 mg/dL (3.9-10 mmol/L) did not differ between groups (79.2 +/- 8.7% vs. 78.2 +/- 6.0%; P = 0.41). Participants randomized to closed-loop insulin delivery spent less time <70 mg/dL (3.9 mmol/L) and <54 mg/dL (3.0 mmol/L) (1.7 +/- 0.8% vs. 5.5 +/- 3.3% [P < 0.001] and 0.3 +/- 0.2% vs. 1.1 +/- 0.9% [P = 0.008]). Time >180 mg/dL (10 mmol/L) was not different between groups (18.7 +/- 8.8% vs. 15.9 +/- 7.7%; P = 0.21). In the continuation phase, those initially randomized to sensor-augmented pump therapy had less time <70 mg/dL after initiation of closed-loop insulin delivery (5.5 +/- 3.3% vs. 3.3 +/- 2.2%; P = 0.039). The closed-loop group maintained similar glycemic metrics in both study phases. There were no episodes of diabetic ketoacidosis or severe hypoglycemia in the randomized or continuation phase in either group. CONCLUSIONS Women randomized to closed-loop insulin delivery postpartum had less hypoglycemia than those randomized to sensor-augmented pump therapy. There were no safety concerns. These findings are reassuring for use of closed-loop insulin delivery postpartum because of its potential to reduce hypoglycemia.
引用
收藏
页码:2258 / 2266
页数:10
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