Omnipod 5 outcomes comparing Dexcom G6 and Freestyle Libre 2 plus users in adults with type 1 diabetes

IF 3.4 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Diabetic Medicine Pub Date : 2024-11-04 DOI:10.1111/dme.15465
Roland H. Stimson, Anna R. Dover, Marcus J. Lyall, Catriona J. Kyle, Rohana J. Wright, Gayle McRobert, Mark W. J. Strachan, Fraser W. Gibb
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Median age was 43 years (IQR 32–56) and diabetes duration was 23 years (14–33). Age (<i>p</i> = 0.872), duration (<i>p</i> = 0.371), sex (<i>p</i> = 0.947), socio-economic deprivation (<i>p</i> = 0.912) and BMI (<i>p</i> = 0.161) did not differ between L2+ and G6 users at baseline. Baseline CGM metrics were not significantly different between G6 and L2+ users (all <i>p</i> &gt; 0.05).</p><p>Time in automode did not differ between groups (G6: 99% [96–100] vs. L2+: 99 [98–100], <i>p</i> = 0.551) and this was also true of time in limited automode (G6: 2% [2–3] vs. L2+: 2 [1–3], <i>p</i> = 0.826). Changes in glucose metrics from baseline are presented in Table 1. Correlation (R) between baseline TIR and change in TIR was −0.91 for L2+ and −0.56 for G6 (both <i>p</i> &lt; 0.001). Logistic regression analysis identified only baseline TIR (OR 0.93 per % [95% CI 0.88–0.97], <i>p</i> &lt; 0.001) but not sensor type (<i>p</i> = 0.723) as an independent predictor of &gt;10% improvement in TIR. 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Abstract

Omnipod 5 (OP5) is a tubeless automated insulin delivery (AID) system that was, until recently, only compatible with Dexcom G6 sensors (G6). Currently, all published evidence attesting to the efficacy of OP5 relates specifically to use with G6 sensors.1, 2 In mid-2024, OP5 compatibility with Freestyle Libre 2 Plus CGM (L2+) was launched in the United Kingdom. This study aimed to compare early glycaemic outcomes, and time spent in AID mode, between those using G6 and L2+ sensors.

This was a retrospective analysis of 77 adults (45 G6 and 32 L2+) with type 1 diabetes at a single centre in the UK. Baseline CGM data were collected in the 28 days prior to converting from Omnipod DASH (standalone CSII) to OP5 and compared with data from the first 28 days of AID use. CGM data were obtained from LibreView and Glooko. Clinical and demographic data were obtained from SCI Diabetes (national diabetes register). As a service evaluation of routinely collected data, this project did not require ethical approval. Paired data were compared with Wilcoxon-signed rank tests and unpaired data with Wilcoxon rank-sum test. Correlations were assessed by the Spearman correlation coefficient. Categorical data were compared by chi-squared test. Logistic regression analysis assessed independent predictors of reduction in TBR and improvement in TIR (defined as >10%). p values <0.05 were considered statistically significant. Statistical analyses were performed using R Studio (version 2023.12.1).

Forty-nine (64%) were female. Median age was 43 years (IQR 32–56) and diabetes duration was 23 years (14–33). Age (p = 0.872), duration (p = 0.371), sex (p = 0.947), socio-economic deprivation (p = 0.912) and BMI (p = 0.161) did not differ between L2+ and G6 users at baseline. Baseline CGM metrics were not significantly different between G6 and L2+ users (all p > 0.05).

Time in automode did not differ between groups (G6: 99% [96–100] vs. L2+: 99 [98–100], p = 0.551) and this was also true of time in limited automode (G6: 2% [2–3] vs. L2+: 2 [1–3], p = 0.826). Changes in glucose metrics from baseline are presented in Table 1. Correlation (R) between baseline TIR and change in TIR was −0.91 for L2+ and −0.56 for G6 (both p < 0.001). Logistic regression analysis identified only baseline TIR (OR 0.93 per % [95% CI 0.88–0.97], p < 0.001) but not sensor type (p = 0.723) as an independent predictor of >10% improvement in TIR. Any fall in TBR was independently associated with baseline TBR (OR 3.4 per % [95% CI 2.0–7.1], p < 0.01) and also the use of G6 sensors (OR 5.8 [95% CI 1.4–34], p = 0.027).

There do not appear to be any important differences in time spent in automode between G6 and L2+. Similarly, early CGM outcomes are comparable between the two CGM options with respect to average glucose, TIR and high glucose metrics. Although the follow-up duration of 28 days is relatively short, TIR outcomes are broadly similar to our recently published 1-year follow-up data,3 suggesting early changes are a durable indicator of longer-term outcomes. Significant improvement in TBR was confined to G6 users but it is debatable whether comparison of such small differences between two CGM systems is clinically meaningful; especially in a population with such low baseline TBR. There is a dearth of published data directly comparing how accurately L2+ and G6 identify glucose levels in the hypoglycaemic range. A small comparison of Freestyle Libre versus Dexcom G6, in non-diabetic adults (30 days of CGM use), reported a TBR of 9.1% using Libre results versus 1.4% using G6.4 These observations suggest we should exercise caution in inferring too much from small differences in TBR between two different glucose sensors. Reduction in CV glucose was greater in the G6 cohort, which could represent differences in the sensor-algorithm interaction but may also reflect baseline differences in TAR. The question of whether one CGM system truly results in superior reduction in TBR and CV glucose will only be resolved by a study with concurrent use of both sensors. These early data offer reassurance that sensor choice with OP5 does not result in clinically meaningful differences in automode performance or CGM metric outcomes.

FWG has received speaker fees from Abbott, Dexcom and Insulet. ARD has received speaker fees from Abbott.

No funding was received.

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Omnipod 5 结果比较了 Dexcom G6 和 Freestyle Libre 2 plus 用户在成人 1 型糖尿病患者中的使用情况。
Omnipod 5 (OP5)是一种无管自动胰岛素输送(AID)系统,直到最近才与Dexcom G6传感器(G6)兼容。目前,所有证实OP5有效性的公开证据都与G6传感器的使用有关。2024年年中,OP5与Freestyle Libre 2 Plus CGM (L2+)的兼容性在英国推出。本研究旨在比较使用G6和L2+传感器的患者在AID模式下的早期血糖结局和时间。这是对英国单一中心77名1型糖尿病成年人(45名G6和32名L2+)的回顾性分析。在从Omnipod DASH(独立CSII)转换为OP5之前的28天内收集基线CGM数据,并与使用AID的前28天的数据进行比较。CGM数据来自LibreView和Glooko。临床和人口统计数据来自SCI Diabetes (national Diabetes register)。作为常规收集数据的服务评估,该项目不需要伦理批准。配对资料采用Wilcoxon符号秩检验,非配对资料采用Wilcoxon秩和检验。用Spearman相关系数评价相关性。分类资料比较采用卡方检验。Logistic回归分析评估TBR降低和TIR改善的独立预测因子(定义为10%)。P值<;0.05认为有统计学意义。统计分析使用R Studio(版本2023.12.1)进行。49例(64%)为女性。中位年龄43岁(IQR 32-56),糖尿病病程23年(14-33)。年龄(p = 0.872)、病程(p = 0.371)、性别(p = 0.947)、社会经济剥夺(p = 0.912)和BMI (p = 0.161)在L2+和G6用户基线时无差异。基线CGM指标在G6和L2+用户之间无显著差异(均p >; 0.05)。在自动机中的时间在两组之间没有差异(G6: 99% [96-100] vs L2+: 99 [98-100], p = 0.551),在有限自动机中的时间也是如此(G6: 2% [2 - 3] vs L2+: 2 [1-3], p = 0.826)。葡萄糖指标与基线的变化见表1。L2+组基线TIR和G6组TIR变化的相关性(R)为- 0.91,G6组为- 0.56 (p < 0.001)。Logistic回归分析仅发现基线TIR (OR 0.93% [95% CI 0.88-0.97], p < 0.001),而传感器类型(p = 0.723)不是TIR改善>;10%的独立预测因子。TBR的任何下降与基线TBR (OR 3.4% [95% CI 2.0-7.1], p < 0.01)和G6传感器的使用(OR 5.8 [95% CI 1.4-34], p = 0.027)独立相关。在G6和L2+之间,在自动模式上花费的时间似乎没有任何重要差异。同样,两种CGM方案的早期CGM结果在平均葡萄糖、TIR和高葡萄糖指标方面具有可比性。虽然28天的随访时间相对较短,但TIR结果与我们最近发表的1年随访数据大致相似,3表明早期变化是长期结果的持久指标。TBR的显著改善仅限于G6使用者,但两种CGM系统之间如此微小差异的比较是否具有临床意义尚存争议;尤其是在TBR基线如此低的人群中。目前缺乏直接比较L2+和G6如何准确识别低血糖范围内的葡萄糖水平的公开数据。在非糖尿病成人(使用CGM 30天)中,自由式Libre与Dexcom G6的小比较报告显示,使用Libre的TBR为9.1%,而使用G6.4的TBR为1.4%。这些观察结果表明,我们应该谨慎地从两种不同葡萄糖传感器之间TBR的微小差异中进行过多推断。G6组的CV葡萄糖下降幅度更大,这可能代表了传感器-算法相互作用的差异,但也可能反映了TAR的基线差异。一个CGM系统是否真的能更好地降低TBR和CV葡萄糖的问题,只有通过同时使用两种传感器的研究才能解决。这些早期数据保证了传感器选择与OP5不会导致汽车模性能或CGM度量结果的临床有意义的差异。FWG已经收到了雅培、Dexcom和Insulet的演讲费。ARD已收到雅培的演讲费。没有收到任何资金。
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来源期刊
Diabetic Medicine
Diabetic Medicine 医学-内分泌学与代谢
CiteScore
7.20
自引率
5.70%
发文量
229
审稿时长
3-6 weeks
期刊介绍: Diabetic Medicine, the official journal of Diabetes UK, is published monthly simultaneously, in print and online editions. The journal publishes a range of key information on all clinical aspects of diabetes mellitus, ranging from human genetic studies through clinical physiology and trials to diabetes epidemiology. We do not publish original animal or cell culture studies unless they are part of a study of clinical diabetes involving humans. Categories of publication include research articles, reviews, editorials, commentaries, and correspondence. All material is peer-reviewed. We aim to disseminate knowledge about diabetes research with the goal of improving the management of people with diabetes. The journal therefore seeks to provide a forum for the exchange of ideas between clinicians and researchers worldwide. Topics covered are of importance to all healthcare professionals working with people with diabetes, whether in primary care or specialist services. Surplus generated from the sale of Diabetic Medicine is used by Diabetes UK to know diabetes better and fight diabetes more effectively on behalf of all people affected by and at risk of diabetes as well as their families and carers.”
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