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胰岛素德谷胰岛素从胰岛素泵转换为多次皮下注射的随机对照试验。

A randomized controlled trial of transition from insulin pump to multiple daily injections using insulin degludec.

机构信息

Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.

出版信息

Diabetes Obes Metab. 2021 Aug;23(8):1936-1941. doi: 10.1111/dom.14423. Epub 2021 Jun 27.

DOI:10.1111/dom.14423
PMID:34180122
Abstract

AIM

To evaluate two methods of transition from an insulin pump to multiple daily injections (MDI) using long-acting insulin degludec (IDeg).

MATERIALS AND METHODS

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.

RESULTS

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.

CONCLUSION

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.

摘要

目的

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。

材料和方法

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。

结果

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。

结论

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。

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