Omaima El Hakouni

Real‐world data are increasingly important for regulatory and health technology assessment decision‐making, yet their effective use across Europe remains limited by technical, methodological, regulatory, and societal challenges. Drawing on the experiences of six Horizon Europe projects in the MetReal cluster, this review summarizes common barriers and emerging solutions for the use of real‐world data in regulatory decision‐making. Key challenges include complex and lengthy data access procedures, fragmented governance frameworks, variable data quality and completeness, limited interoperability, methodological difficulties in analyzing heterogeneous datasets, and infrastructure constraints within secure data environments. The article highlights opportunities to address these barriers through improved metadata, harmonization, federated analytics, synthetic data sandboxes, sustainable funding, and stronger collaboration between researchers, regulators, health technology assessment bodies, data holders, and citizens. These recommendations aim to strengthen Europe's health data ecosystem and support more robust, efficient, and trusted evidence generation for public health and patient benefit.

Background and Aims: In people with insulin‐treated diabetes experiencing hypoglycaemia, the multicentre Hypo‐METRICS study found that 60% of sensor‐detected hypoglycaemic episodes (SDH) were asymptomatic, and over 40% of person‐reported hypoglycaemia (PRH) occurred at glucose levels ≥70 mg/dL (3.9 mmol/L). This subanalysis explored participants' experiences of these episodes to identify possible clinical implications. Methods: Fifty‐eight Austrian participants received a 15‐item questionnaire on their experience of asymptomatic hypoglycaemia and symptoms at glucose levels ≥70 mg/dL (3.9 mmol/L). Results: The response rate was 86% ( n = 50). Among all participants, 56% ( n = 28) reported experiencing hypoglycaemic symptoms at glucose levels ≥70 mg/dL (3.9 mmol/L) “sometimes” or “often.” They attributed this to a combination of a threshold shift due to chronic hyperglycaemia, rapid glucose decline and fear of hypoglycaemia. 68% of all SDH < 70 mg/dL and 59% of those below the clinically critical level of 54 mg/dL were asymptomatic. Conclusion: These results demonstrate that SDH and PRH each capture different, yet equally important, dimensions of the hypoglycaemia experience. Relying on only one source of information inevitably provides an incomplete picture. By integrating the patient's voice, diabetes professionals can provide appropriate support and tailor continuous glucose monitoring (CGM) alarm settings and treatment plans to truly meet individual needs.

Aims: Continuous glucose monitoring (CGM) systems are increasingly used, but their accuracy under flight‐conditions remains insufficiently studied. We assessed sensor accuracy of four CGMs during in‐flight (mid‐haul) and ground conditions. Materials and Methods: Participants ( n = 20) wore four sensors (Abbott Libre 3, Dexcom G7, Medtronic Simplera, and Sinocare iCan i3) in parallel, inserted 1 day prior to experiment. Capillary reference measurements were performed every 30 min. Accuracy evaluation included: proportion of CGM values within 10% of comparator glucose levels >100 mg/dL or within 10 mg/days of comparator levels ≤100 mg/dL (%10/10), along with %20/20 agreement rates, mean absolute relative difference (MARD), Consensus error grid. Results: Twenty participants with type 1 diabetes (age: 37.9 ± 12.8 years, HbA1c: 52.3 ± 4.9 mmol/mol, diabetes duration 19.25 ± 10.6 years) were included in the analysis. Data from 297 sensors with 3473 matched pairs (G7/Libre3/Simplera/i3) were analysed. The overall MARDs were: 9.5% ± 3.3% (G7), 9.6% ± 3.8% (Libre3), 19.9% ± 6.2% (Simplera) and 15.7% ± 6.6% (i3). Overall %20/20 and %10/10 agreement rates were 90.6%/70.2% (G7), 90.8%/66.8% (Libre3), 63.6%/37.8% (Simplera) and 72.5%/42.2% (i3) respectively. The proportion of values in Zones A and B of the Consensus error grid was 98.9% (G7), 99.0% (Libre 3), 94.5% (Simplera) and 97.5% (i3). Prandial state and flight phase had limited influence on the relative performance ranking of the devices. Conclusions: G7 and Libre3 showed consistently higher accuracy and clinical reliability across various phases of flight and ground conditions. Simplera and i3 exhibited greater variability in accuracy. These findings suggest that while modern CGMs could support diabetes management in aviation, individual system performance may differ under specific operational conditions.

Background: Automated insulin delivery systems (AID) are increasingly used by people living with type 1 diabetes, but their functionality during air travel remains insufficiently studied. Some concerns have arisen regarding safety using AID systems under flight conditions, particularly related to potential insulin delivery errors induced by cabin pressure changes. Methods: This study assessed the safety and efficacy commercial AIDs in 20 adults with type 1 diabetes (age: 37.9 ± 12.8 years, HbA1c: 52.3 ± 4.9 mmol/mol, TIR: 74 ± 9.8%, diabetes duration: 19.25 ± 10.6 years) during mid‐haul commercial flights and matched ground‐based conditions (MiniMed780G; Omnipod 5; Control‐IQ; and CamAPS FX with YpsoPump, n = 5 per system). Outcomes included time in range (TIR, 3.9–10.0 mmol/L), time in tight range (TITR, 3.9–7.8 mmol/L), time above range 1 (TAR1, 10.1–13.9 mmol/L), time above range 2 (TAR2, >13.9 mmol/L), time below range 1 (TBR1, 3.0–3.8 mmol/L), time below range 2 (TBR2, <3.0 mmol/L), and total daily insulin doses. Results: Overall TIR was 88.2 ± 13.5% in‐flight versus 82.1 ± 17.7% on‐ground. The mean difference in TIR was 4.6%, (95% CI: −5.0‐ 14.2). Other overall metrics (in‐flight versus on‐ground) were: TITR = 67.7 ± 19.4% vs. 64.2 ± 18.1%, TAR = 7.1 ± 10.5% vs. 12.0 ± 13.8% and TBR = 4.7 ± 7.2% vs. 5.9 ± 15.7%. Insulin delivery was slightly increased in‐flight (25.4 ± 17.6 IU vs. 18.7 ± 11.6 IU), driven by bolus dosing (17.8 ± 13.3 IU vs. 11.9 ± 6.6 IU). No episodes of level 2 hypoglycaemia, diabetic ketoacidosis, or device failure occurred. Conclusions: AID systems maintained robust glycaemic control and safety during commercial flights, comparable to ground‐based conditions. These data support the feasibility of in‐flight AIDs use and provide a basis for future regulatory and clinical practice updates. Larger, multicenter studies are needed to generalize findings.