Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Diabetes Obes Metab. 2021 Aug;23(8):1936-1941. doi: 10.1111/dom.14423. Epub 2021 Jun 27.
To evaluate two methods of transition from an insulin pump to multiple daily injections (MDI) using long-acting insulin degludec (IDeg).
After a 1-week run-in period, adults with type 1 diabetes for longer than 1 year and HbA1c 48-69 mmol/mol (6.5%-8.5%), who had been using an insulin pump at least for 6 months, were randomly transitioned to either standard of care (discontinued insulin pump and started IDeg in 1:1 dose) or overlap (IDeg 1:1 at pump basal dose, but pump continued for the first 48 hours with a gradual basal reduction; 50% from 0-24 hours, 75% from 24-48 hours and then pump discontinued). Participants used blinded Dexcom G6 and the IDeg dose was not changed during the trial. Primary (% time above 180 mg/dL) and secondary (% time in 70-180 mg/dL and below 70 mg/dL) outcomes were compared between the two groups during 7 days of randomization.
Age, gender, diabetes duration and basal/bolus insulin doses were similar between patients randomized to standard of care (n = 17) or overlap (n = 13) transition. Compared with overlap transition, the standard of care group spent 4.8% more time in hyperglycaemia (least square mean 4.8% [95% CI -3.3%, 12.9%]) and 5.3% less time in range (-5.3% [-12.6%, -2.0%]), without a significant difference in hypoglycaemia (0.5% [-2.3%,3.4%]). No treatment-related adverse events were noted in either group.
The overlap transition method may result in a significant improvement in time-in-range without increasing hypoglycaemia during the first week of transition from an insulin pump to MDI using IDeg in adults with type 1 diabetes.
评估使用长效胰岛素德谷胰岛素(IDeg)从胰岛素泵转为多次皮下注射(MDI)的两种方法。
在为期 1 周的导入期后,1 型糖尿病病程超过 1 年且糖化血红蛋白(HbA1c)为 48-69mmol/mol(6.5%-8.5%)的成年患者,且至少使用胰岛素泵治疗 6 个月,被随机分为标准治疗组(停止使用胰岛素泵并以 1:1 的剂量开始使用 IDeg)或重叠组(以胰岛素泵基础剂量的 1:1 比例给予 IDeg,但泵继续使用最初的 48 小时,基础剂量逐渐减少;0-24 小时减少 50%,24-48 小时减少 75%,然后停止使用泵)。在试验期间,参与者使用了盲法 Dexcom G6,且 IDeg 剂量未发生改变。在随机分组的 7 天内,比较两组之间主要(>180mg/dL 的时间百分比)和次要(70-180mg/dL 和<70mg/dL 的时间百分比)结局。
标准治疗组(n=17)和重叠组(n=13)患者的年龄、性别、糖尿病病程和基础/餐时胰岛素剂量相似。与重叠组相比,标准治疗组高血糖时间比例增加了 4.8%(最小二乘均数 4.8%[95%CI-3.3%,12.9%]),血糖达标时间比例减少了 5.3%(-5.3%[-12.6%,-2.0%]),而低血糖时间比例无显著差异(0.5%[-2.3%,3.4%])。两组均未发生与治疗相关的不良事件。
在使用 IDeg 从胰岛素泵转为 MDI 的过程中,与标准治疗组相比,重叠转换方法可能会使血糖达标时间显著增加,而不会增加第 1 周的低血糖风险。