Risk for ketonaemia in type 1 diabetes pregnancies with sensor-augmented pump therapy with predictive low glucose suspend compared with low glucose suspend: a crossover RCT,Diabetologia

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Risk for ketonaemia in type 1 diabetes pregnancies with sensor-augmented pump therapy with predictive low glucose suspend compared with low glucose suspend: a crossover RCT
Diabetologia ( IF 8.4 ) Pub Date : 2021-10-13 , DOI: 10.1007/s00125-021-05589-y
Katrien Benhalima ₁ , Falco van Nes ₂ , Annouschka Laenen ₃ , Pieter Gillard ₁ , Chantal Mathieu ₁

Affiliation

Aims

To determine the frequency of ketonaemia in pregnant women with type 1 diabetes treated with a sensor-augmented pump (SAP) in predictive low glucose suspend (PLGS) mode compared with low glucose suspend (LGS) mode.

Methods

An open-label crossover pilot RCT in ten women with type 1 diabetes treated with a 640 Medtronic insulin pump, with inclusion between 12–30 weeks of pregnancy. Participants were 1/1 randomly assigned (allocation by statistician using a permuted block size of 2) to either 2 weeks with an SAP in PLGS mode or 2 weeks in LGS mode. After the first 2 weeks, participants were switched to the other mode. Ketones in the participants’ serum were measured three times daily (fasting, midday and evening) during the 4 weeks. The primary endpoint was the frequency of blood ketones > 0.6 mmol/l. Participants and healthcare providers were not blinded to group assignment for assessment of outcomes.

Results

The median gestational week at inclusion was 12.5 weeks (12.0–15.0), participants had a median age of 31.5 years (24.0–33.0), BMI of 26.6 kg/m² (24.5–31.8), baseline HbA_1c of 41 mmol/mol (40–43; 5.9% [5.8–6.1]) and baseline time in range (TIR, 3.5–7.8 mmol/l) of 64.6% (55.6–68.7). Comparing the LGS mode with the PLGS mode, insulin suspension time per day was 2.0 h (1.3–2.3) vs 3.5 h (3.3–5.0; p = 0.002), ketonaemia > 0.6 mmol/l was 0% vs 0.5% (p = 1.000) and no participants had ketonaemia > 1 mmol/l. TIR on LGS was 64.7% (58.0–68.7) vs 61.1% (56.5–67.5) on PLGS (p = 0.492), time < 3.5 mmol/l was higher on LGS at 7.5% (4.6–8.3) vs 4.2% (2.4–6.9) on PLGS (p = 0.014). Treatment satisfaction and fear for hypoglycaemia were similar whether using LGS or PLGS mode.

Conclusions/interpretation

Despite longer time periods with suspended insulin delivery, pregnant women using an SAP in PLGS mode were not at higher risk of developing ketonaemia compared with those in LGS mode. Women with an SAP in PLGS mode had similar TIR with less time in hypoglycaemia.

Trial registration

Clinical Trials NCT04292509

Funding

This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

Graphical abstract

中文翻译：

与低血糖暂停相比，传感器增强泵治疗与预测性低血糖暂停相比，1 型糖尿病妊娠的酮血症风险：一项交叉 RCT

目标

确定在预测性低葡萄糖暂停 (PLGS) 模式与低葡萄糖暂停 (LGS) 模式下使用传感器增强泵 (SAP) 治疗的 1 型糖尿病孕妇的酮血症发生率。

方法

一项开放标签交叉试点 RCT，纳入 10 名 1 型糖尿病女性，使用 640 美敦力胰岛素泵治疗，纳入妊娠 12-30 周。参与者被 1/1 随机分配（由统计学家使用 2 的置换块大小分配）到 PLGS 模式下使用 SAP 的 2 周或 LGS 模式下的 2 周。前 2 周后，参与者切换到另一种模式。在 4 周内，每天测量 3 次参与者血清中的酮（禁食、中午和晚上）。主要终点是血酮 > 0.6 mmol/l 的频率。参与者和医疗保健提供者并未对结果评估的分组分配视而不见。

结果

纳入时的中位孕周为 12.5 周 (12.0–15.0)，参与者的中位年龄为 31.5 岁 (24.0–33.0)，BMI 为 26.6 kg/m ² (24.5–31.8)，基线 HbA _1c为 41 mmol/mol (40–43; 5.9% [5.8–6.1]) 和基线时间范围 (TIR, 3.5–7.8 mmol/l) 为 64.6% (55.6–68.7)。LGS 模式与 PLGS 模式比较，每天胰岛素暂停时间分别为 2.0 h (1.3-2.3) vs 3.5 h (3.3-5.0; p = 0.002)，酮血症 > 0.6 mmol/l 分别为 0% vs 0.5% ( p = 1.000）并且没有参与者的酮血症> 1 mmol / l。LGS 上的 TIR 为 64.7% (58.0–68.7) 与 PLGS 上的 61.1% (56.5–67.5) ( p = 0.492)，LGS 上的时间 < 3.5 mmol/l 更高，分别为 7.5% (4.6–8.3) 与 4.2% (2.4 –6.9) 在 PLGS ( p = 0.014)。无论是使用 LGS 还是 PLGS 模式，治疗满意度和对低血糖的恐惧都相似。