Day-and-night closed-loop in a broad population of pregnant women with type 1 diabetes: a randomized controlled crossover trial

Autor: Stewart, Zoe A., Wilinska, Malgorzata E., Hartnell, Sara, O’Neil, Leanne K, Rayman, Gerry, Scott, Eleanor M., Barnard, Katharine, Farrington, Conor, Hovorka, Roman, Murphy, Helen R.
Jazyk: angličtina
Rok vydání: 2018
Popis: OBJECTIVE Despite advances in technology, optimal glucose control remains elusive and neonatal complications ubiquitous in type 1 diabetes (T1D) pregnancy. Our aim was to examine the safety, efficacy, and longer-term feasibility of day-and-night closed-loop insulin delivery. RESEARCH DESIGN AND METHODS We recruited 16 pregnant women (mean [SD]: age 32.8 [5.0] years, T1D duration 19.4 [10.2] years, HbA1c 8.0% [1.1%], BMI 26.6 [4.4] kg/m2) to an open-label, randomized, crossover trial. Participants completed 28 days of closed-loop and sensor-augmented pump (SAP) insulin delivery separated by a washout period. Afterward, participants could continue to use the closed-loop system up to 6 weeks postpartum. The primary end point was the proportion of time with glucose levels within the target range (63–140 mg/dL). RESULTS The proportion of time with glucose levels within target was comparable during closed-loop and SAP insulin delivery (62.3 vs. 60.1% [95% CI −4.1 to 8.3%]; P = 0.47). Mean glucose and time spent hyperglycemic >140 mg/dL also did not differ (131.4 vs. 131.4 mg/dL [P = 0.85] and 36.6 vs. 36.1% [P = 0.86], respectively). During closed-loop, fewer hypoglycemic episodes occurred (median [range] 8 [1–17] vs. 12.5 [1–53] over 28 days; P = 0.04) and less time at
Databáze: OpenAIRE