Dataset Information

Bolus Insulin Dose Error Distributions Based on Results From Two Clinical Trials Comparing Blood Glucose Monitoring Systems.

ABSTRACT:

Background

In 2 previous clinical trials, fingertip capillary blood samples were evaluated using prespecified blood glucose monitoring systems (BGMSs) and a reference YSI glucose analyzer. In post hoc analyses, hypothetical insulin doses were calculated using these blood glucose measurements; dosing errors were compared for each trial.

Method

For each blood glucose measurement, premeal bolus insulin dosing was determined for a hypothetical person, assuming a 60-g carbohydrate meal and 100-mg/dL target blood glucose level (adjusting 1/25 insulin sensitivity and 1/15 insulin:carbohydrate ratio inputs to account for BGMS measurement error). Dosing error was the difference between doses calculated using the BGMS and YSI results.

Results

In Clinical Trial 1, 95% dose error ranges (in units of insulin) were: CONTOUR^®NEXT EZ BGMS (EZ), -0.9 to 0.5; Accu-Chek^® Aviva BGMS (ACA), -0.5 to 1.8; FreeStyle Freedom Lite^® BGMS (FFL), -3.2 to -0.3; OneTouch^® Ultra^®2 BGMS (OTU2), -4.1 to 0.3; and Truetrack^® BGMS (TT), -3.9 to 2.2. In Clinical Trial 2, these ranges were: CONTOUR^®NEXT BGMS (CN), -0.7 to 1.7; Accu-Chek^® Aviva Nano BGMS (ACAN), -1.3 to 1.8; FreeStyle Lite^® BGMS (FSL), -5.1 to 0.2; OTU2, -1.9 to 1.2; OneTouch^® Verio^® Pro BGMS (OTVP), -1.0 to 1.9; and TT, -5.1 to 1.7. Within each trial, EZ and CN had statistically significantly smaller insulin dose error ranges than other BGMSs ( P <0.0001).

Conclusions

The ranges of insulin dose errors were statistically significantly smaller with EZ and CN than with all other BGMSs in this post hoc analysis. Differences in BGMS accuracy could result in clinically important differences in insulin dosing.

SUBMITTER: Pardo S

PROVIDER: S-EPMC5950998 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Publications

Bolus Insulin Dose Error Distributions Based on Results From Two Clinical Trials Comparing Blood Glucose Monitoring Systems.

Pardo Scott S Dunne Nancy N Simmons David A DA

Journal of diabetes science and technology 20170612 5

<h4>Background</h4>In 2 previous clinical trials, fingertip capillary blood samples were evaluated using prespecified blood glucose monitoring systems (BGMSs) and a reference YSI glucose analyzer. In post hoc analyses, hypothetical insulin doses were calculated using these blood glucose measurements; dosing errors were compared for each trial.<h4>Method</h4>For each blood glucose measurement, premeal bolus insulin dosing was determined for a hypothetical person, assuming a 60-g carbohydrate meal ...[more]

PMID: 28604064

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Project description:BackgroundContinuous glucose monitorings (CGMs) have been used to manage diabetes with reasonable glucose control amongst patients with type 2 diabetes (T2D) in recent decades. CGMs measure interstitial fluid glucose levels to provide information about glucose levels, which identify fluctuation that would not have been identified with conventional self-monitoring. Self-monitoring of blood glucose (SMBG) is a classical tool to measure glycaemic changes. However, the effectiveness of glucose control, hypoglycemia, weight change, quality of life and user satisfaction, are needed to evaluate and compare CGMs and SMBG amongst adults with T2D.MethodsThe review will compare the various forms of CGM systems (i.e flash CGM, real-time CGM, retrospective CGM) versus SMBG or usual intervention regarding diabetes management amongst adults with T2D. The following databases will be searched: Cochrane Library, PubMed, EMBASE, CINAHL, PsycINFO, Scopus and grey literature (ClinicalTrials.gov, PsycEXTRA, ProQuest Dissertations, Google Scholar and Theses Global) for the identification of studies. The studies involving adults (aged ≥ 18 years old) will be included. We will only include and summarise randomised clinical trials (RCTs) with respect to authors, publication type, year, status and type of devices. Studies published in English between February 2010 and March 2020, will be included as the field of CGMs amongst T2D patients has emerged over the last decade. Primary outcomes will be HbA1c (glycosylated haemoglobin level) (mmol/L), body weight (kg), time spent with hypoglycaemia (< 70 mg/dl) or hyperglycaemia (≥ 180 mg/dl), blood pressure (< 140/90 mmHg is considered as good management) and quality of life (understanding and feeling of living situation based on culture and value system). Secondary outcome measures will be user satisfaction (patient or treatment/intervention satisfaction or satisfaction scale) and barriers (physical and mental difficulties or issues). Study selection, data extraction and risk of bias assessment will be conducted independently by at least two reviewers. A third reviewer will determine and resolve discrepancies. Moreover, the quality of the evidence of the review will be assessed according to the Grading of Recommendations Assessment, Development and Evaluation tool (GRADE).DiscussionThe review will synthesise evidence on the comparison between using CGMs and SMBG. The results will support researchers and health professionals to determine the most effective methods/technologies in the overall diabetes management.Systematic review registrationPROSPERO CRD42020149212.

Dataset Information

Bolus Insulin Dose Error Distributions Based on Results From Two Clinical Trials Comparing Blood Glucose Monitoring Systems.

Background

Method

Results

Conclusions

Publications

Bolus Insulin Dose Error Distributions Based on Results From Two Clinical Trials Comparing Blood Glucose Monitoring Systems.

Similar Datasets

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