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Predictors of Time-in-Range (70-180 mg/dL) Achieved Using a Closed-Loop Control System.

ABSTRACT: Background: Studies of closed-loop control (CLC) in patients with type 1 diabetes (T1D) consistently demonstrate improvements in glycemic control as measured by increased time-in-range (TIR) 70-180 mg/dL. However, clinical predictors of TIR in users of CLC systems are needed. Materials and Methods: We analyzed data from 100 children aged 6-13 years with T1D using the Tandem Control-IQ CLC system during a randomized trial or subsequent extension phase. Continuous glucose monitor data were collected at baseline and during 12-16 weeks of CLC use. Participants were stratified into quartiles of TIR on CLC to compare clinical characteristics. Results: TIR for those in the first, second, third, and fourth quartiles was 54%, 65%, 71%, and 78%, respectively. Lower baseline TIR was associated with lower TIR on CLC (r = 0.69, P < 0.001). However, lower baseline TIR was also associated with greater improvement in TIR on CLC (r = -0.81, P < 0.001). During CLC, participants in the highest versus lowest TIR-quartile administered more user-initiated boluses daily (8.5 ± 2.8 vs. 5.8 ± 2.6, P < 0.001) and received fewer automated boluses (3.5 ± 1.0 vs. 6.0 ± 1.6, P < 0.001). Participants in the lowest (vs. the highest) TIR-quartile received more insulin per body weight (1.13 ± 0.27 vs. 0.87 ± 0.20 U/kg/d, P = 0.008). However, in a multivariate model adjusting for baseline TIR, user-initiated boluses and insulin-per-body-weight were no longer significant. Conclusions: Higher baseline TIR is the strongest predictor of TIR on CLC in children with T1D. However, lower baseline TIR is associated with the greatest improvement in TIR. As with open-loop systems, user engagement is important for optimal glycemic control.

SUBMITTER: Schoelwer MJ

PROVIDER: S-EPMC8252894 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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Predictors of Time-in-Range (70-180 mg/dL) Achieved Using a Closed-Loop Control System.

Schoelwer Melissa J MJ Kanapka Lauren G LG Wadwa R Paul RP Breton Marc D MD Ruedy Katrina J KJ Ekhlaspour Laya L Forlenza Gregory P GP Cobry Erin C EC Messer Laurel H LH Cengiz Eda E Jost Emily E Carria Lori L Emory Emma E Hsu Liana J LJ Weinzimer Stuart A SA Buckingham Bruce A BA Lal Rayhan A RA Oliveri Mary Clancy MC Kollman Craig C CC Dokken Betsy B BB Cherñavvsky Daniel R DR Beck Roy W RW DeBoer Mark D MD

Diabetes technology & therapeutics 20210309 7

Background: Studies of closed-loop control (CLC) in patients with type 1 diabetes (T1D) consistently demonstrate improvements in glycemic control as measured by increased time-in-range (TIR) 70-180 mg/dL. However, clinical predictors of TIR in users of CLC systems are needed. Materials and Methods: We analyzed data from 100 children aged 6-13 years with T1D using the Tandem Control-IQ CLC system during a randomized trial or subsequent extension phase. Continuous gluco ...[more]

PMID: 33689454

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Project description:BackgroundWhile time in targeted blood glucose range (TIR) 70-140 mg/dL is a known factor associated with mortality in critically ill patients, it remains unclear whether TIR is associated with 28-day mortality under the glycemic control with a less tight target glucose range of 70-180 mg/dL. We aimed to examine whether TIR 70-180 mg/dL was associated with 28-day mortality.MethodsThis is a retrospective cohort study using data from a tertiary care center in Japan collected from January 2016 through October 2019. We included adult patients (aged ≥20 years) admitted to the ICU. We excluded patients 1) with diabetic ketoacidosis patients, 2) discharged within 48 hours, 3) with repeated ICU admissions. We calculated TIR 70-180 mg/dL using the measured blood glucose values (≥3 times per day). The primary outcome was 28-day mortality. We examined the association between TIR and 28-day mortality using a logistic regression and Cox proportional hazard models with a stratification by glycosylated hemoglobin (HbA1c) level of 6.5%. Additionally, we repeated the analyses using the TIR category to assess the optimal TIR. For the sensitivity analysis, we repeated the primary analysis using TIR during the first three days from ICU admission.ResultsOf 1,230 patients, the median age was 72 years, 65% were male, and 250 patients (20%) had HbA1c ≥6.5% on admission. In patients with HbA1c <6.5%, TIR <80% was associated with an increased risk of 28-day mortality, with an adjusted odds ratio (OR) of 1.88 (95%CI: 1.36-2.61). Likewise, when using 10% incremental TIR as a categorical variable, lower TIR was associated with a worse 28-day mortality compared with TIR ≥90% (e.g., adjusted OR of TIR <60%, 3.62 [95%CI 2.36-5.53]). Similar associations were found in the analyses using Cox proportional hazards model and using TIR during the first three days. By contrast, in patients with HbA1c ≥6.5%, there was no consistent association of TIR with 28-day mortality.ConclusionsWe found that lower TIR 70-180 mg/dL was associated with a higher 28-day mortality in critically ill patients with HbA1c <6.5%, whereas there was no consistent association in patients with HbA1c ≥6.5%.

Project description:BackgroundPrevious studies revealed a linear relationship between body mass index (BMI) and repeat coronary revascularization rate in patients who underwent percutaneous coronary intervention (PCI). However, this relationship has not been demonstrated in Korean patients who meet old and new target low-density lipoprotein cholesterol (LDL-C) levels of Korean dyslipidemia guidelines. Therefore, we conducted this study to find out the effect of BMI on repeat coronary revascularization rate in patients with LDL-C <55 mg/dL and patients with LDL-C <70 mg/dL.MethodsThis cohort study was followed for 42 months in Daegu Catholic Medical Center, Korea. We included 429 patients with LDL-C <70 mg/dL 1 year after PCI. We compared repeat revascularization rates using Kaplan-Meier survival curves between the normal weight group (18.5 kg/m2 ≤ BMI < 23 kg/m2) and the pre-obesity and obesity group (23 kg/m2 ≤ BMI) in patients with LDL-C <55 mg/dL and patients with LDL-C <70 mg/dL.ResultsDuring a follow-up period, there was no significant difference in repeat coronary revascularization-free survival between a group with LDL-C <55 mg/dL and a group with LDL-C <70 mg/dL (79.6% vs. 76.2%, P=0.32). In normal weight patients, LDL-C <55 mg/dL group showed higher repeat coronary revascularization-free survival than LDL-C <70 mg/dL group (89.3% vs. 77.1%, P=0.05). There was no significant difference in repeat revascularization-free survival between the normal weight group and the pre-obesity and obesity group in patients with LDL-C <70 mg/dL (77.1% vs. 75.7%, P=0.67). However, the normal weight group showed significantly higher repeat revascularization-free survival compared to the pre-obesity and obesity group in patients with LDL-C <55 mg/dL (89.3% vs. 74.3%, P=0.03). Normal body weight and LDL-C <55 mg/dL [hazard ratio (HR): 0.421, 95% confidence interval (CI): 0.193-0.916, P=0.02] was the only independent predictor for repeat revascularization.ConclusionsIn Korean PCI patients with normal body weight whose LDL-C level is less than 70 mg/dL, but more than 55 mg/dL, should be treated with more intensive therapy to lower LDL-C to less than 55 mg/dL. For obese patients who have succeeded in reducing LDL-C below 55 mg/dL, it seems that weight loss should be attempted to a normal body weight level.

Project description:BackgroundThe risk of stroke in individuals with very low low-density lipoprotein cholesterol (LDL-C) concentrations remains high. We sought to prioritize predictive risk factors for stroke in Chinese participants with LDL-C concentrations < 70 mg/dL using a survival conditional inference tree, a machine learning method.MethodsThe training dataset included 9327 individuals with LDL-C concentrations < 70 mg/dL who were free of cardiovascular diseases and did not use lipid-modifying drugs from the Kailuan I study (N = 101,510). We examined the validity of this algorithm in a second Chinese cohort of 1753 participants with LDL-C concentrations < 70 mg/dL from the Kailuan II study (N = 35,856).ResultsDuring a mean 8.5-9.0-year follow-up period, we identified 388 ischemic stroke cases and 145 hemorrhagic stroke cases in the training dataset and 20 ischemic stroke cases and 8 hemorrhagic stroke cases in the validation dataset. Of 15 examined predictors, poorly controlled blood pressure and very low LDL-C concentrations (≤ 40 mg/dL) were the top hierarchical predictors of both ischemic stroke risk and hemorrhagic stroke risk. The groups, characterized by the presence of 2-3 of aforementioned risk factors, were associated with a higher risk of ischemic stroke (hazard ratio (HR) 7.03; 95% confidence interval (CI) 5.01-9.85 in the training dataset; HR 4.68, 95%CI 1.58-13.9 in the validation dataset) and hemorrhagic stroke (HR 3.94, 95%CI 2.54-6.11 in the training dataset; HR 4.73, 95%CI 0.81-27.6 in the validation dataset), relative to the lowest risk groups (presence of 0-1 of these factors). There was a linear association between cumulative average LDL-C concentrations and stroke risk. LDL-C concentrations ≤ 40 mg/dL was significantly associated with increased risk of ischemic stroke (HR 2.07, 95%CI 1.53, 2.80) and hemorrhagic stroke (HR 2.70, 95%CI 1.70, 4.30) compared to LDL-C concentrations of 55-70 mg/dL, after adjustment for age, hypertension status, and other covariates.ConclusionIndividuals with extremely low LDL-C concentrations without previous lipid-modifying treatment could still be at high stroke risk.Trial registrationChinese Clinical Trial Register, ChiCTR-TNRC-11001489 . Registered on 24-08-2011.

Dataset Information

Predictors of Time-in-Range (70-180 mg/dL) Achieved Using a Closed-Loop Control System.

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Predictors of Time-in-Range (70-180 mg/dL) Achieved Using a Closed-Loop Control System.

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