ArticleJournal of diabetes science and technology2026
Retrospective Validation of a Stage 5 Decision Support Algorithm Using Clinical Trial Data From Stage 4 Smart Insulin Pens.
Article in Journal of diabetes science and technology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06406439 (A Multicenter, Open Label, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Electric Smart Insulin Pen DIA), which is not on this map. Not yet cited in PubMed.
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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.
A Multicenter, Open Label, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Electric Smart Insulin Pen DIA:CONN P8 in Patients With Type 1, Type 2 or Pancreatogenic Diabetes Mellitus Under Multiple Dose Insulin Therapy
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Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe evaluated whether the frequency of algorithm-generated coaching events, a decision support system (DSS) integrated with a smart insulin pen (SIP), differed according to glycemic outcomes, thereby establishing the algorithmic foundation.
methodsThis retrospective analysis evaluated continuous glucose monitoring (CGM) and SIP data from a 12-week randomized controlled trial (NCT06406439) involving individuals with diabetes managed with multiple daily injections (MDI). A total of 338 biweekly CGM profiles from 58 participants were analyzed. For each 14-day period, the coaching event frequency was calculated across 9 predefined coaching categories.
resultsFrequencies of hyperglycemia-related coaching (time in range [TIR]: 18.8 vs 34.8; time above range [TAR > 180 mg/dL]: 18.3 vs 33.8) and missed bolus events (TIR: 7.6 vs 11.2; TAR: 7.0 vs 11.1) were significantly higher in profiles not meeting hyperglycemia-related CGM targets (all
conclusionsThe frequency of algorithm-based coaching events served as a robust indicator of glycemic control. These findings validate Stage 5 SIP-integrated DSS and suggest its potential utility in identifying unresolved glycemic issues in individuals treated with MDI.
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Registered trials
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