Canha Dulce, Choudhary Pratik, Cosson Emmanuel, Banu Isabela, Barraud Sara, Valéro René, Ronci Nathalie, Delenne Blandine, Dufaitre Lise, Vidal-Trecan Tiphaine, Schaepelynck Pauline, Sanz Caroline, Tatulashvili Sopio, Aguayo Gloria A, Fagherazzi Guy, Riveline Jean-Pierre
Deep Digital Phenotyping Research Unit, Department of Precision Health, Luxembourg Institute of Health, Strassen, Luxembourg.
Faculty of Science, Technology and Medicine, University of Luxembourg, Esch-sur-Alzette, Luxembourg.
Diabetologia. 2025 Sep 9. doi: 10.1007/s00125-025-06536-x.
AIMS/HYPOTHESIS: Severe hypoglycaemia events (SHE) remain frequent in people with type 1 diabetes despite advanced diabetes technologies. We examined whether time below range (TBR) 3.9 mmol/l (70 mg/dl; TBR70) or 3.0 mmol/l (54 mg/dl; TBR54) is associated with future SHE risk and whether impaired awareness of hypoglycaemia (IAH) modifies this relationship.
We analysed data from participants in the Study of the French-speaking Society of Type 1 Diabetes (SFDT1) who used continuous glucose monitoring. IAH was assessed using the Gold Score (≤2, no IAH; 3, undetermined; ≥4, IAH). SHE frequency was self-reported 12 months after inclusion. We analysed associations between TBR and SHE using logistic regression models adjusted for age, sex, social vulnerability and insulin treatment, including TBR-IAH interactions. We performed spline analyses to explore non-linear patterns.
One-year incidence of SHE was 11.7% among 848 participants (mean ± SD age 41.6 ± 13.3 years; 53.8% female sex, HbA 57.2 ± 10.9 mmol/mol [7.4 ± 1.0%]). Incidence by TBR70 was 12.1% for ≤1%, 10.2% for 1.1-3.9%, 10.6% for 4-6%, and 14.6% for >6%. Only those with TBR70 >6% and IAH had a significantly higher SHE risk (OR 3.32 [95% CI 1.40, 7.82]) compared with TBR70 ≤1% and no IAH. For TBR54, SHE incidence was 11.0% and 13.3% for categories <1% and ≥1%, respectively. Similarly, only individuals with TBR54≥1% and IAH had increased SHE risk (OR 2.99 [95% CI 1.46, 5.92]). Spline analysis showed low, stable SHE risk across TBR70 values in participants without IAH, with a non-linear pattern only in those with IAH.
CONCLUSIONS/INTERPRETATION: TBR alone is not discriminative for high-risk SHE but combining TBR with hypoglycaemia awareness status identifies those at the highest risk for both TBR70 and TBR54.
ClinicalTrials.gov NCT04657783.
目的/假设：尽管有先进的糖尿病技术，但1型糖尿病患者严重低血糖事件（SHE）仍然频发。我们研究了血糖低于3.9 mmol/l（70 mg/dl；TBR70）或3.0 mmol/l（54 mg/dl；TBR54）的时间是否与未来SHE风险相关，以及低血糖意识受损（IAH）是否会改变这种关系。
我们分析了法语区1型糖尿病学会（SFDT1）研究中使用持续葡萄糖监测的参与者的数据。使用金氏评分评估IAH（≤2，无IAH；3，未确定；≥4，IAH）。SHE频率在纳入后12个月通过自我报告获得。我们使用针对年龄、性别、社会脆弱性和胰岛素治疗进行调整的逻辑回归模型分析TBR与SHE之间的关联，包括TBR-IAH相互作用。我们进行样条分析以探索非线性模式。
848名参与者中SHE的一年发病率为11.7%（平均±标准差年龄41.6±13.3岁；女性占53.8%，糖化血红蛋白57.2±10.9 mmol/mol [7.4±1.0%]）。TBR70≤1%时发病率为12.1%，1.1 - 3.9%时为10.2%，4 - 6%时为10.6%，>6%时为14.6%。与TBR70≤1%且无IAH相比，只有TBR70>6%且有IAH的参与者SHE风险显著更高（比值比3.32 [95%置信区间1.40, 7.82]）。对于TBR54，<1%和≥1%类别中SHE发病率分别为11.0%和13.3%。同样，只有TBR54≥1%且有IAH的个体SHE风险增加（比值比2.99 [95%置信区间1.46, 5.92]）。样条分析显示，无IAH的参与者中，TBR70各值对应的SHE风险较低且稳定，仅在有IAH的参与者中呈非线性模式。
结论/解读：单独的TBR对高风险SHE无鉴别作用，但将TBR与低血糖意识状态相结合可识别出TBR70和TBR54风险最高的人群。
ClinicalTrials.gov NCT04657783
