Dataset Information

Randomized Controlled Trial of Mobile Closed-Loop Control.

ABSTRACT:

Objective

Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system.

Research design and methods

This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ?14 years, and baseline HbA_1c <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L.

Results

Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC (n = 65) versus SAP (n = 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference -1.7% [95% CI -2.4, -1.0]; P < 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference -3.0% [95% CI -6.1, 0.1]; P < 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device.

Conclusions

In meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.

SUBMITTER: Kovatchev B

PROVIDER: S-EPMC7035585 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Publications

Randomized Controlled Trial of Mobile Closed-Loop Control.

Kovatchev Boris B Anderson Stacey M SM Raghinaru Dan D Kudva Yogish C YC Laffel Lori M LM Levy Carol C Pinsker Jordan E JE Wadwa R Paul RP Buckingham Bruce B Doyle Francis J FJ Brown Sue A SA Church Mei Mei MM Dadlani Vikash V Dassau Eyal E Ekhlaspour Laya L Forlenza Gregory P GP Isganaitis Elvira E Lam David W DW Lum John J Beck Roy W RW

Diabetes care 20200114 3

<h4>Objective</h4>Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system.<h4>Research design and methods</h4>This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA<sub>1c</sub> <10.5% (91 mmol/mol). The study was designed ...[more]

PMID: 31937608

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Project description:BackgroundCognitive changes after anesthesia and surgery represent a significant public health concern. We tested the hypothesis that, in patients 60 yr or older scheduled for noncardiac surgery, automated management of anesthetic depth, cardiac blood flow, and protective lung ventilation using three independent controllers would outperform manual control of these variables. Additionally, as a result of the improved management, patients in the automated group would experience less postoperative neurocognitive impairment compared to patients having standard, manually adjusted anesthesia.MethodsIn this single-center, patient-and-evaluator-blinded, two-arm, parallel, randomized controlled, superiority study, 90 patients having noncardiac surgery under general anesthesia were randomly assigned to one of two groups. In the control group, anesthesia management was performed manually while in the closed-loop group, the titration of anesthesia, analgesia, fluids, and ventilation was performed by three independent controllers. The primary outcome was a change in a cognition score (the 30-item Montreal Cognitive Assessment) from preoperative values to those measures 1 week postsurgery. Secondary outcomes included a battery of neurocognitive tests completed at both 1 week and 3 months postsurgery as well as 30-day postsurgical outcomes.ResultsForty-three controls and 44 closed-loop patients were assessed for the primary outcome. There was a difference in the cognition score compared to baseline in the control group versus the closed-loop group 1 week postsurgery (-1 [-2 to 0] vs. 0 [-1 to 1]; difference 1 [95% CI, 0 to 3], P = 0.033). Patients in the closed-loop group spent less time during surgery with a Bispectral Index less than 40, had less end-tidal hypocapnia, and had a lower fluid balance compared to the control group.ConclusionsAutomated anesthetic management using the combination of three controllers outperforms manual control and may have an impact on delayed neurocognitive recovery. However, given the study design, it is not possible to determine the relative contribution of each controller on the cognition score.

Dataset Information

Randomized Controlled Trial of Mobile Closed-Loop Control.

Objective

Research design and methods

Results

Conclusions

Publications

Randomized Controlled Trial of Mobile Closed-Loop Control.

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