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Randomized Crossover Comparison of Automated Insulin Delivery Versus Conventional Therapy Using an Unlocked Smartphone with Scheduled Pasta and Rice Meal Challenges in the Outpatient Setting.

ABSTRACT: Background: Automated Insulin Delivery (AID) hybrid closed-loop systems have not been well studied in the context of prescribed meals. We evaluated performance of our interoperable artificial pancreas system (iAPS) in the at-home setting, running on an unlocked smartphone, with scheduled meal challenges in a randomized crossover trial. Methods: Ten adults with type 1 diabetes completed 2 weeks of AID-based control and 2 weeks of conventional therapy in random order where they consumed regular pasta or extra-long grain white rice as part of a complete dinner meal on six different occasions in both arms (each meal thrice in random order). Surveys assessed satisfaction with AID use. Results: Postprandial differences in conventional therapy were 10,919.0 mg/dL × min (95% confidence interval [CI] 3190.5-18,648.0, P = 0.009) for glucose area under the curve (AUC) and 40.9 mg/dL (95% CI 4.6-77.3, P = 0.03) for peak continuous glucose monitor glucose, with rice showing greater increases than pasta. White rice resulted in a lower estimate over pasta by a factor of 0.22 (95% CI 0.08-0.63, P = 0.004) for AUC under 70 mg/dL. These glycemic differences in both meal types were reduced under AID-based control and were not statistically significant, where 0-2 h insulin delivery decreased by 0.45 U for pasta (P = 0.001) and by 0.27 U for white rice (P = 0.01). Subjects reported high overall satisfaction with the iAPS. Conclusions: The AID system running on an unlocked smartphone improved postprandial glucose control over conventional therapy in the setting of challenging meals in the outpatient setting. Clinical Trial Registry: clinicaltrials.gov NCT03767790.

SUBMITTER: Deshpande S

PROVIDER: S-EPMC7757622 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundComputerized order entry systems have the potential to prevent medication errors and decrease adverse drug events with the use of clinical-decision support systems presenting alerts to providers. Despite the large volume of medications prescribed in the outpatient setting, few studies have assessed the impact of automated alerts on medication errors related to drug-laboratory interactions in an outpatient primary-care setting.Methods and findingsA primary-care clinic in an integrated safety net institution was the setting for the study. In collaboration with commercial information technology vendors, rules were developed to address a set of drug-laboratory interactions. All patients seen in the clinic during the study period were eligible for the intervention. As providers ordered medications on a computer, an alert was displayed if a relevant drug-laboratory interaction existed. Comparisons were made between baseline and postintervention time periods. Provider ordering behavior was monitored focusing on the number of medication orders not completed and the number of rule-associated laboratory test orders initiated after alert display. Adverse drug events were assessed by doing a random sample of chart reviews using the Naranjo scoring scale. The rule processed 16,291 times during the study period on all possible medication orders: 7,017 during the pre-intervention period and 9,274 during the postintervention period. During the postintervention period, an alert was displayed for 11.8% (1,093 out of 9,274) of the times the rule processed, with 5.6% for only "missing laboratory values," 6.0% for only "abnormal laboratory values," and 0.2% for both types of alerts. Focusing on 18 high-volume and high-risk medications revealed a significant increase in the percentage of time the provider stopped the ordering process and did not complete the medication order when an alert for an abnormal rule-associated laboratory result was displayed (5.6% vs. 10.9%, p = 0.03, Generalized Estimating Equations test). The provider also increased ordering of the rule-associated laboratory test when an alert was displayed (39% at baseline vs. 51% during post intervention, p < 0.001). There was a non-statistically significant difference towards less "definite" or "probable" adverse drug events defined by Naranjo scoring (10.3% at baseline vs. 4.3% during postintervention, p = 0.23).ConclusionProviders will adhere to alerts and will use this information to improve patient care. Specifically, in response to drug-laboratory interaction alerts, providers will significantly increase the ordering of appropriate laboratory tests. There may be a concomitant change in adverse drug events that would require a larger study to confirm. Implementation of rules technology to prevent medication errors could be an effective tool for reducing medication errors in an outpatient setting.

Project description:BackgroundHypoxia is common during daily nursing procedures (DNPs) routinely performed on mechanically ventilated patients. The impact of automated ventilation on the incidence and severity of blood oxygen desaturation during DNPs remains unknown.MethodsA prospective randomized controlled crossover trial was carried out in a French intensive care unit to compare blood oxygen pulse saturation (SpO2) during DNPs performed on patients mechanically ventilated in automated and conventional ventilation modes (AV and CV, respectively). All patients with FiO2 ≤ 60% and without prone positioning or neuromuscular blocking agents were included. Patients underwent two DNPs on the same day using AV (INTELLiVENT-ASV®) and CV (volume control, biphasic positive airway pressure, or pressure support ventilation) in a randomized order. The primary outcome was the percentage of time spent with SpO2 in the acceptable range of 90-95% during the DNP.ResultsOf the 265 included patients, 93% had been admitted for a medical pathology, the majority for acute respiratory failure (52%). There was no difference between the two periods in terms of DNP duration, sedation requirements, or ventilation parameters, but patients had more spontaneous breaths and lower peak airway pressures during the AV period (p < 0.001). The percentage of time spent with SpO2 in the acceptable range during DNPs was longer in the AV period than in the CV period (48 ± 37 vs. 43 ± 37, percentage of DNP period; p = 0.03). After adjustment, AV was associated with a higher number of DNPs carried out with SpO2 in the acceptable range (odds ratio, 1.82; 95% CI, 1.28 to 2.6; p = 0.001) and a lower incidence of blood oxygen desaturation ≤ 85% (adjusted odds ratio, 0.50; 95% CI, 0.30 to 0.85; p = 0.01).ConclusionAV appears to reduce the incidence and severity of blood oxygen desaturation during daily nursing procedures (DNPs) in comparison to CV.Trial registrationThis study was registered in clinical-trial.gov ( NCT03176329 ) in June 2017.

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Randomized Crossover Comparison of Automated Insulin Delivery Versus Conventional Therapy Using an Unlocked Smartphone with Scheduled Pasta and Rice Meal Challenges in the Outpatient Setting.

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