Feasibility of Closed-Loop Insulin Delivery with a Pregnancy-Specific Zone Model Predictive Control Algorithm

Özaslan, Başak; Levy, Carol J.; Kudva, Yogish C.; Pinsker, Jordan E.; O’Malley, Grenye; Kaur, Ravinder; Castorino, Kristin; Levister, Camilla; Trinidad, Mari Charisse; Desjardins, Donna; Church, Mei Mei; Plesser, Mitchell D.; McCrady-Spitzer, Shelly K.; Ogyaadu, Selassie; Nelson, Kristen L.; Reid, Corey; Deshpande, Sunil; Kremers, Walter K.; Doyle, Francis J.; Rosenn, Barak; Dassau, Eyal

doi:10.1089/dia.2021.0521

Cited by 13 publications

(9 citation statements)

References 34 publications

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“…This closed loop system allows the user to personalise their glucose target, allowing them to achieve tighter control. Other commercially available closed loop systems do not allow the patient to reduce the target glucose to the levels required in pregnancy, but are often used either off-label or as SAP during pregnancy ( 100 , 101 ). There are a number of ongoing randomised controlled trials aiming to evaluate commercial closed loop technology in pregnancy ( 102 ), NCT03774186, NCT04902378, NCT04520971, NCT04938557.…”

Section: Technologiesmentioning

confidence: 99%

Glycaemic control and novel technology management strategies in pregestational diabetes mellitus

2023

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IntroductionPregestational diabetes (PGDM) is an increasingly common and complex condition that infers risk to both mother and infant. To prevent serious morbidity, strict glycaemic control is essential. The aim of this review is to review the glucose sensing and insulin delivering technologies currently available for women with PGDM.MethodsWe reviewed online databases for articles relating to technology use in pregnancy using a combination of keywords and MeSH headings. Relevant articles are included below.ResultsA number of technological advancements have improved care and outcomes for women with PGDM. Real time continuous glucose monitoring (rtCGM) offers clear advantages in terms of infants size and neonatal intensive care unit admissions; and further benefits are seen when combined with continuous subcutaneous insulin delivery (insulin pump) and algorithms which continuously adjust insulin levels to glucose targets (hybrid closed loop). Other advancements including flash or intermittent scanning CGM (isCGM) and stand-alone insulin pumps do not confer as many advantages for women and their infants, however they are increasingly used outside of pregnancy and many women enter pregnancy already using these devices.DiscussionThis article offers a discussion of the most commonly used technologies in pregnancy and evaluates their current and future roles.

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Section: Technologiesmentioning

confidence: 99%

Glycaemic control and novel technology management strategies in pregestational diabetes mellitus

2023

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“…[ 12 ] Special populations, such as gestational diabetes mellitus, require more stringent glucose targets, which are often set in the range of 63 to 140 mg/dL (3.5–7.8 mmol/L). [ 5 , 13 ] For neonates with unstable insulin sensitivity and high energy requirements (especially premature infants), the target range is typically 47 to 180 mg/dL (2.6–10.0 mmol/L), though it can also be set narrower in an RCT evaluating the effectiveness of maintaining euglycemia (72–144 mg/dL [4.0–8.0 mmol/L]) in very preterm infants while the ranges of 47 to 71 mg/dL (2.6–7.9 mmol/L) and 145–180 mg/dL (4.1–10.0 mmol/L) are defined as mild hypoglycemia and mild hyperglycemia, respectively. [ 14 ] In addition, it can be difficult for children with T1DM to achieve the target TIR safely (avoiding excessive hypoglycemia) when the target range of TIR is set at 70 to 180 mg/dL (3.9–10.0 mmol/L).…”

Section: Definition Of Time In Rangementioning

confidence: 99%

“…When calculating TIR in healthy or prediabetic populations, researchers may modify the target range to 54 to 140 mg/dL (3.0–7.9 mmol/L), which includes part of the physiologic asymptomatic hypoglycemia range [12] . Special populations, such as gestational diabetes mellitus, require more stringent glucose targets, which are often set in the range of 63 to 140 mg/dL (3.5–7.8 mmol/L) [5,13] . For neonates with unstable insulin sensitivity and high energy requirements (especially premature infants), the target range is typically 47 to 180 mg/dL (2.6–10.0 mmol/L), though it can also be set narrower in an RCT evaluating the effectiveness of maintaining euglycemia (72–144 mg/dL [4.0–8.0 mmol/L]) in very preterm infants while the ranges of 47 to 71 mg/dL (2.6–7.9 mmol/L) and 145–180 mg/dL (4.1–10.0 mmol/L) are defined as mild hypoglycemia and mild hyperglycemia, respectively [14] .…”

Section: Definition Of Time In Rangementioning

confidence: 99%

Research progress in the application of time in range: more than a percentage

Wan

et al. 2023

Chinese Medical Journal

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Glucose monitoring is an important part of medical care in diabetes mellitus, which not only helps assess glycemic control and treatment safety, but also assists with treatment adjustment. With the development of continuous glucose monitoring (CGM), the use of CGM has increased rapidly. With the wealth of glucose data produced by CGM, new metrics are greatly needed to optimally evaluate glucose status and guide the treatment. One of the parameters that CGM provides, time in range (TIR), has been recognized as a key metric by the international consensus. Before the adoption of TIR in clinical practice, several issues including the minimum length of CGM use, the setting of the target range, and individualized TIR goals are summarized. Additionally, we discussed the mounting evidence supporting the association between TIR and diabetes-related outcomes. As a novel glucose metric, it is of interest to compare TIR with other conventional glucose markers such as glycated hemoglobin A1c. It is anticipated that the use of TIR may provide further information on the quality of glucose control and lead to improved diabetes management.

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“…We excluded inappropriate publication types, animal experiments, and unrelated research topics and then identified six studies on APS use among pregnant women with T1DM for eligibility. Upon full-text assessment, two non-RCTs 29,30 were excluded, and a total of four RCTs [25][26][27][28] were ultimately included. The PRISMA flow diagram is shown in Figure 1.…”

Section: Identification Of Studiesmentioning

confidence: 99%

“…Until now, most studies on APS use in pregnant women with T1DM have been case reports, [12][13][14][15][16][17][18][19][20][21][22][23][24] with only a few available randomized controlled trials (RCTs) [25][26][27][28] and non-RCTs that have small sample sizes. 29,30 We conducted the present meta-analysis of the few RCTs to assess the efficacy of APS use among pregnant women with T1DM.…”

Section: Introductionmentioning

confidence: 99%

Effect of artificial pancreas system use on glycaemic control among pregnant women with type 1 diabetes mellitus: A meta‐analysis of randomized controlled trials

Lei,

Chen,

Ling

et al. 2023

Diabetes Obesity Metabolism

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AimTo assess the efficacy of artificial pancreas systems (APS) use among pregnant women with type 1 diabetes mellitus (T1DM) by conducting a meta‐analysis.MethodsWe searched five databases, including EMBASE, Web of Science, PubMed, Cochrane Library and SCOPUS, for literature on APS use among pregnant women with T1DM before October 9, 2023. The primary endpoint was 24‐hour time in range (TIR; 3.5‐7.8 mmol/L). Secondary endpoints included glycaemic metrics for 24‐hour (mean blood glucose [MBG], time above range [TAR], time below range [TBR]), and overnight TIR and TBR.ResultsWe identified four randomized controlled trials involving 164 participants; one study with 16 participants focused on overnight APS use, and the other three focused on 24‐hour APS use. Compared with standard care, APS exhibited a favourable effect on 24‐hour TIR (standard mean difference [SMD] = 0.53, 95% confidence interval [CI] 0.25, 0.80, P < 0.001), overnight TIR (SMD = 0.67, 95% CI 0.39, 0.95, P < 0.001), and overnight TBR (<3.5 mmol/L; SMD = −0.49, 95% CI −0.77, −0.21 P < 0.001), while there was no significant difference in 24‐hour TAR, 24‐hour TBR, or MBG between the two groups. We further conducted subgroup analyses after removing the trial focused on overnight APS use and showed that 24‐hour APS use reduced not only the 24‐hour TIR (SMD = 0.41, 95% CI 0.12, 0.71; P = 0.007) but also the 24‐hour TBR (<2.8 mmol/L; SMD = −0.77, 95% CI −1.32, −0.23, P = 0.006).ConclusionOur findings suggest that APS might improve 24‐hour TIR and overnight glycaemic control, and 24‐hour APS use also significantly reduced 24‐hour TBR (2.8 mmol/L) among pregnant women with T1DM.

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Feasibility of Closed-Loop Insulin Delivery with a Pregnancy-Specific Zone Model Predictive Control Algorithm

Cited by 13 publications

References 34 publications

Glycaemic control and novel technology management strategies in pregestational diabetes mellitus

Glycaemic control and novel technology management strategies in pregestational diabetes mellitus

Research progress in the application of time in range: more than a percentage

Effect of artificial pancreas system use on glycaemic control among pregnant women with type 1 diabetes mellitus: A meta‐analysis of randomized controlled trials

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