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Burnside, Mercedes J; Lewis, Dana M; Crocket, Hamish R; Meier, Renee A; Williman, Jonathan A; Sanders, Olivia J; Jefferies, Craig A; Faherty, Ann M; Paul, Ryan G; Lever, Claire S; Price, Sarah K J; Frewen, Carla M; Jones, Shirley D; Gunn, Tim C; Lampey, Christina; Wheeler, Benjamin J; de Bock, Martin I
Diabetes technology & therapeutics, 04/2023, Letnik: 25, Številka: 4Journal Article
To assess long-term efficacy and safety of open-source automated insulin delivery (AID) in children and adults (7-70 years) with type 1 diabetes. Both arms of a 24-week randomized controlled trial comparing open-source AID (OpenAPS algorithm within a modified version of AndroidAPS, preproduction DANA-i™ insulin pump, Dexcom G6 continuous glucose monitor) with sensor-augmented pump therapy (SAPT), entered a 24-week continuation phase where the SAPT arm (termed SAPT-AID) crossed over to join the open-source AID arm (termed AID-AID). Most participants (69/94) used a preproduction YpsoPump insulin pump during the continuation phase. Analyses incorporated all 52 weeks of data, and combined between-group and within-subject differences to calculate an overall "treatment effect" of AID versus SAPT. Mean time in range (TIR; 3.9-10 mmol/L 70-180 mg/dL) was 12.2% higher with AID than SAPT (95% confidence interval CI 10.4 to 14.1; < 0.001). TIR was 56.9% (95% CI 54.2 to 59.6) with SAPT and 69.1% (95% CI 67.1 to 71.1) with AID. The treatment effect did not differ by age ( = 0.39) or insulin pump type ( = 0.37). HbA1c was 5.1 mmol/mol lower 0.5% with AID (95% CI -6.6 to -3.6; < 0.001). There were no episodes of diabetic ketoacidosis or severe hypoglycemia with either treatment over the 48 weeks. Six participants (all in SAPT-AID) withdrew: three with hardware issues, two preferred SAPT, and one with infusion-site skin irritation. Further evaluation of the community derived automated insulin delivery (CREATE) trial to 48 weeks confirms that open-source AID is efficacious and safe with different insulin pumps, and demonstrates sustained glycemic improvements without additional safety concerns.
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Dostop do baze podatkov JCR je dovoljen samo uporabnikom iz Slovenije. Vaš trenutni IP-naslov ni na seznamu dovoljenih za dostop, zato je potrebna avtentikacija z ustreznim računom AAI.
Leto | Faktor vpliva | Izdaja | Kategorija | Razvrstitev | ||||
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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in: SICRIS
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