Pedersen Kenney Fehrenkamp, Østerskov Anne, Nielsen Sabrina Mai, Karagkounis Gkikas, Knudsen Astrid Karnøe
Clinical and Medical Affairs, Hedia ApS, Copenhagen, Denmark.
Section for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
Front Digit Health. 2025 Mar 27;7:1430744. doi: 10.3389/fdgth.2025.1430744. eCollection 2025.
Individuals living with type 1 diabetes are at risk of long-term complications related to chronic hyperglycemia. Tight glycemic control is recommended but can increase the risk of iatrogenic hypoglycemia. Hedia Diabetes Assistant (HDA) is a bolus calculator that provides users with bolus insulin recommendations based on personalized settings. We aimed to investigate the effects of HDA on a known risk index of hypoglycemia.
New users from 2019 to 2021 were included if they fulfilled the following criteria: age ≥18 years, ≥5 logs/1st week of use, and ≥1 log for glucose, carbohydrate, and insulin. User data was extracted from the HDA database. The prespecified primary endpoint was change in the Low Blood Glucose Index (LBGI) after 12 weeks of use. Secondary endpoints were changes in the High Blood Glucose Index (HBGI) and eA1c. An exploratory endpoint was to maintain potential improvements in LBGI after 25 weeks. A repeated-measures mixed model with a log-transformation was used.
A total of 1,342 users were included. The mean age was 43.4 years (SD 14.7) with 52.3% being female. After 12 weeks, LBGI significantly improved from 0.73 to 0.61 (17% decrease, < 0.001) with no significant changes in HBGI, and eA1c. From week 12 to 25, LBGI decreased from 0.61 to 0.55 (10%, = 0.107).
Users of HDA experienced statistically significant improvement in LBGI after 12 weeks with no changes in HBGI and eA1c, which was successfully maintained after 25 weeks. These results suggest a decreased risk of hypoglycemia when using HDA.
1型糖尿病患者面临与慢性高血糖相关的长期并发症风险。建议严格控制血糖，但这可能会增加医源性低血糖的风险。Hedia糖尿病助手（HDA）是一种推注计算器，可根据个性化设置为用户提供推注胰岛素建议。我们旨在研究HDA对已知低血糖风险指数的影响。
纳入2019年至2021年的新用户，需满足以下标准：年龄≥18岁，使用第一周记录≥5次，血糖、碳水化合物和胰岛素记录≥1次。用户数据从HDA数据库中提取。预先设定的主要终点是使用12周后低血糖指数（LBGI）的变化。次要终点是高血糖指数（HBGI）和糖化血红蛋白（eA1c）的变化。一个探索性终点是在25周后维持LBGI的潜在改善。使用了带有对数转换的重复测量混合模型。
共纳入1342名用户。平均年龄为43.4岁（标准差14.7），女性占52.3%。12周后，LBGI从0.73显著改善至0.61（降低17%，<0.001），HBGI和eA1c无显著变化。从第12周到第25周，LBGI从0.61降至0.55（降低10%，P = 0.107）。
HDA用户在使用12周后LBGI有统计学意义上的显著改善，HBGI和eA1c无变化，并在25周后成功维持。这些结果表明使用HDA时低血糖风险降低。
