Nefrocenter Research and Nyx Start-Up, Naples, Italy.
Department of Internal Medicine, Campania University "Luigi Vanvitelli", Naples, Italy.
Adv Ther. 2022 May;39(5):2192-2207. doi: 10.1007/s12325-022-02105-5. Epub 2022 Mar 19.
The history of insulin-induced skin lipohypertrophy (LH) runs parallel to that of insulin's 100 years, and an average of 47% of insulin-treated patients still suffer from it today. The metabolic and economic effects of LH are significant, with hypoglycemia being the most striking. The objective of the study was to perform a 52-week follow-up of 713 insulin-treated patients with type 2 diabetes (T2DM) and LH to detect any differences in the occurrence of hypoglycemic events (HYPOs) and related healthcare costs as well as in LH rates and injection habits between an intensive education intervention group (IG) and control group (CG) provided with a single educational session at the starting point.
All participants were trained in accurately self-monitoring blood glucose and recording all HYPOs for 6 months, which allowed baseline recordings before they were randomized into the IG, comprising 395 insulin-treated subjects undergoing repeated, structured multimodal education on correct injection techniques as a longstanding behavioral rehabilitation strategy, and the CG, comprising 318 subjects receiving the same structured, multimodal educational session, but only initially.
Changes in LH rate and size and in performance were large in the IG and only slight and transient in the CG. A striking difference in the rate of decrease of HYPOs was also apparent between groups. Indeed, estimated costs of health interventions for severe and symptomatic HYPOs, which were on the order of €70,000 and €9300, respectively, in the two groups at baseline decreased by 5.9 times and 13.7 times, respectively, at the end of follow-up in the IG and by only approximately half in the CG. Full details of the changes occurring as a result of intensive education are provided in the text.
The effect of only initial education in the CG was not significant, thus providing evidence of the virtual worthlessness of a single training session on injection techniques, typical of worldwide daily clinical practice, and easily explaining the extremely high prevalence of LH in insulin-treated patients. Conversely, highly positive effects on LH prevalence and size as well as costs expected from decreased HYPO rate were obtained in the IG. To our knowledge, ours is the first 18-month randomized trial in the field. If our experimental model were to be used as an effective, longstanding behavioral rehabilitation strategy and therefore adapted to real-world settings universally, LH prevalence and costs related to their clinical consequences would be drastically reduced. However, only with a strong, relentless commitment of universities, scientific societies, and patient associations can we achieve this ambitious goal, which would provide great institutional savings and improved quality of life for people with diabetes.
胰岛素引起的皮下脂肪肥厚（LH）的历史与胰岛素的 100 年历史并行，如今仍有平均 47%的胰岛素治疗患者受其影响。LH 对代谢和经济的影响是显著的，其中最引人注目的是低血糖。本研究的目的是对 713 例 2 型糖尿病（T2DM）和 LH 接受胰岛素治疗的患者进行 52 周的随访，以检测强化教育干预组（IG）和对照组（CG）之间低血糖事件（HYPOs）的发生、相关医疗成本以及 LH 发生率和注射习惯是否存在差异，其中 IG 在起始点接受单次教育课程，CG 则提供单次教育课程。
所有参与者均接受过准确的自我监测血糖和记录所有 HYPOs 的培训，为期 6 个月，在随机分为 IG 和 CG 之前，进行基线记录。IG 由 395 例接受胰岛素治疗的患者组成，他们接受了反复、结构化的多模式教育，以了解正确的注射技术，这是一种长期的行为康复策略，CG 则由 318 例患者组成，他们接受了相同的结构化、多模式教育课程，但仅接受了一次。
IG 中 LH 发生率、大小和表现的变化较大，而 CG 中的变化较小且短暂。两组之间 HYPO 发生率的下降也存在明显差异。事实上，两组基线时严重和有症状的 HYPOs 的健康干预费用分别约为 7 万欧元和 9300 欧元，在 IG 中分别下降了 5.9 倍和 13.7 倍，而在 CG 中仅下降了约一半。文中详细介绍了强化教育所带来的变化。
CG 中仅接受初始教育的效果并不显著，因此证明了单次注射技术培训课程的价值微乎其微，这种情况在全球日常临床实践中很常见，也很容易解释为什么胰岛素治疗的患者中 LH 的发病率极高。相反，IG 中 LH 发病率和大小以及预期因 HYPO 发生率下降而降低的成本均有显著的积极影响。据我们所知，这是该领域首次进行的为期 18 个月的随机试验。如果我们的实验模型被用作一种有效的、长期的行为康复策略，并因此在全球范围内普遍适用，那么 LH 的发病率和与临床后果相关的成本将大幅降低。然而，只有通过大学、科学协会和患者协会的大力、不懈的努力，我们才能实现这一雄心勃勃的目标，这将为糖尿病患者带来巨大的机构节省和提高生活质量。
