一种新型护理模式用于2型糖尿病管理1年的有效性和安全性：一项开放标签、非随机对照研究。
Effectiveness and Safety of a Novel Care Model for the Management of Type 2 Diabetes at 1 Year: An Open-Label, Non-Randomized, Controlled Study.
作者信息
Hallberg Sarah J, McKenzie Amy L, Williams Paul T, Bhanpuri Nasir H, Peters Anne L, Campbell Wayne W, Hazbun Tamara L, Volk Brittanie M, McCarter James P, Phinney Stephen D, Volek Jeff S
机构信息
Medically Supervised Weight Loss, Indiana University Health Arnett, Lafayette, IN, USA.
Virta Health, San Francisco, CA, USA.
出版信息
Diabetes Ther. 2018 Apr;9(2):583-612. doi: 10.1007/s13300-018-0373-9. Epub 2018 Feb 7.
INTRODUCTION
Carbohydrate restriction markedly improves glycemic control in patients with type 2 diabetes (T2D) but necessitates prompt medication changes. Therefore, we assessed the effectiveness and safety of a novel care model providing continuous remote care with medication management based on biometric feedback combined with the metabolic approach of nutritional ketosis for T2D management.
METHODS
We conducted an open-label, non-randomized, controlled, before-and-after 1-year study of this continuous care intervention (CCI) and usual care (UC). Primary outcomes were glycosylated hemoglobin (HbA), weight, and medication use. Secondary outcomes included fasting serum glucose and insulin, HOMA-IR, blood lipids and lipoproteins, liver and kidney function markers, and high-sensitivity C-reactive protein (hsCRP).
RESULTS
349 adults with T2D enrolled: CCI: n = 262 [mean (SD); 54 (8) years, 116.5 (25.9) kg, 40.4 (8.8) kg m, 92% obese, 88% prescribed T2D medication]; UC: n = 87 (52 (10) years, 105.6 (22.15) kg, 36.72 (7.26) kg m, 82% obese, 87% prescribed T2D medication]. 218 participants (83%) remained enrolled in the CCI at 1 year. Intention-to-treat analysis of the CCI (mean ± SE) revealed HbA declined from 59.6 ± 1.0 to 45.2 ± 0.8 mmol mol (7.6 ± 0.09% to 6.3 ± 0.07%, P < 1.0 × 10), weight declined 13.8 ± 0.71 kg (P < 1.0 × 10), and T2D medication prescription other than metformin declined from 56.9 ± 3.1% to 29.7 ± 3.0% (P < 1.0 × 10). Insulin therapy was reduced or eliminated in 94% of users; sulfonylureas were entirely eliminated in the CCI. No adverse events were attributed to the CCI. Additional CCI 1-year effects were HOMA-IR - 55% (P = 3.2 × 10), hsCRP - 39% (P < 1.0 × 10), triglycerides - 24% (P < 1.0 × 10), HDL-cholesterol + 18% (P < 1.0 × 10), and LDL-cholesterol + 10% (P = 5.1 × 10); serum creatinine and liver enzymes (ALT, AST, and ALP) declined (P ≤ 0.0001), and apolipoprotein B was unchanged (P = 0.37). UC participants had no significant changes in biomarkers or T2D medication prescription at 1 year.
CONCLUSIONS
These results demonstrate that a novel metabolic and continuous remote care model can support adults with T2D to safely improve HbA, weight, and other biomarkers while reducing diabetes medication use. CLINICALTRIALS.
GOV IDENTIFIER
NCT02519309.
FUNDING
Virta Health Corp.
引言
碳水化合物限制可显著改善2型糖尿病（T2D）患者的血糖控制，但需要及时调整药物治疗。因此，我们评估了一种新型护理模式的有效性和安全性，该模式基于生物特征反馈并结合营养性酮症的代谢方法，为T2D管理提供持续的远程护理和药物管理。
方法
我们对这种持续护理干预（CCI）和常规护理（UC）进行了一项为期1年的开放标签、非随机、对照、前后对照研究。主要结局指标为糖化血红蛋白（HbA）、体重和药物使用情况。次要结局指标包括空腹血糖和胰岛素、HOMA-IR、血脂和脂蛋白、肝肾功能指标以及高敏C反应蛋白（hsCRP）。
结果
349例T2D成人患者入组：CCI组：n = 262[平均（标准差）；54（8）岁，116.5（25.9）kg，40.4（8.8）kg/m²，92%为肥胖患者，88%正在使用T2D药物治疗]；UC组：n = 87（52（10）岁，105.6（22.15）kg，36.72（7.26）kg/m²，82%为肥胖患者，87%正在使用T2D药物治疗]。1年后，218名参与者（83%）仍留在CCI组。对CCI组进行意向性分析（均值±标准误）显示，HbA从59.6±1.0降至45.2±0.8 mmol/mol（7.6±0.09%至6.3±0.07%，P < 1.0×10⁻⁴），体重下降13.8±0.71 kg（P < 1.0×10⁻⁴），除二甲双胍外的T2D药物处方率从56.9±3.1%降至29.7±3.0%（P < 1.0×10⁻⁴）。94%的使用者减少或停用了胰岛素治疗；CCI组完全停用了磺脲类药物。未发现CCI组有不良事件。CCI组1年的其他效果包括HOMA-IR降低55%（P = 3.2×10⁻⁴），hsCRP降低39%（P < 1.0×10⁻⁴），甘油三酯降低24%（P < 1.0×10⁻⁴），高密度脂蛋白胆固醇升高18%（P < 1.0×10⁻⁴），低密度脂蛋白胆固醇升高10%（P = 5.1×10⁻³）；血清肌酐和肝酶（ALT、AST和ALP）下降（P≤0.0001），载脂蛋白B无变化（P = 0.37）。UC组参与者在1年时生物标志物或T2D药物处方无显著变化。
结论
这些结果表明，一种新型的代谢和持续远程护理模式可以帮助T2D成人患者安全地改善HbA、体重和其他生物标志物，同时减少糖尿病药物的使用。临床试验。
美国国立医学图书馆临床试验标识符
NCT02519309。
资助
Virta Health Corp.
Zotero 插件