Trial reportJournal of diabetes science and technology2015
Evaluation of a Methodology for Estimating HbA1c Value by a New Glucose Meter.
Trial report in Journal of diabetes science and technology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01885546 (Accuracy Study for the Evaluation of Obtaining an Enhanced Meter Feature Using an AgaMatrix BGMS), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Accuracy Study for the Evaluation of Obtaining an Enhanced Meter Feature Using an AgaMatrix BGMS
Who cites it
1 citing paper in PubMed.
- The Glucose Measurement Industry and Hemoglobin A1c: An Opportunity for Creative Destruction.Journal of diabetes science and technology · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAccuracy/robustness of HbA1c estimation (eA1c) with an algorithm built into the MyStar Extra blood glucose (BG) meter has been demonstrated by in silico testing. We evaluated the performance and use of eA1c in a clinical setting.
methodsSubjects took the BG meter home for 4 months to obtain eA1c in this open-label, single-center study. Laboratory HbA1c values were obtained approximately every 2 weeks and the corresponding eA1c documented. Subjects completed a questionnaire at study end (NCT01885546).
resultsThere were 133 enrolled subjects (mean [SD] age 60.0 [15.0] years, 69 males, 104 with diabetes, HbA1c 7.0% [1.4]). A total of 1008 pairs of eA1c and laboratory HbA1c values were available. In subjects with diabetes, 97.5% of the eA1c results fell within ± 20% of the laboratory HbA1c, 95.0% within ± 18%, and 90.7% within ± 15%. When results were limited to the reportable HbA1c range of ≥ 6 to ≤ 10%, 99.3% of eA1c values fell within ± 20% of the laboratory HbA1c, 98.5% within ± 18%, and 96.2% within ± 15% Most subjects agreed/strongly agreed that the eA1c section in the user guide and flash cards was easy to follow (72%), they would use the system to track their eA1c (70%), they found the eA1c tool helpful (79%), and the tool may motivate them to manage their diabetes better (83%).
conclusionsAccuracy of the eA1c feature in this clinical setting was similar to the performance in silico. The majority of subjects found this tool helpful and agreed it may motivate to manage their diabetes better.
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