1. 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
- Author
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Mei Mei Church, Francis J. Doyle, Jennifer Massa, David Eisenberg, Molly Piper, Eyal Dassau, Camille C. Andre, Sunil Deshpande, and Jordan E. Pinsker
- Subjects
Adult ,Blood Glucose ,Pancreas, Artificial ,medicine.medical_specialty ,Endocrinology, Diabetes and Metabolism ,Crossover ,Insulin delivery ,MEDLINE ,ComputerApplications_COMPUTERSINOTHERSYSTEMS ,030209 endocrinology & metabolism ,Context (language use) ,Artificial pancreas ,03 medical and health sciences ,Insulin Infusion Systems ,0302 clinical medicine ,Endocrinology ,Diabetes mellitus ,Outpatients ,Dietary Carbohydrates ,medicine ,Humans ,Insulin ,030212 general & internal medicine ,Meals ,Type 1 diabetes ,Meal ,Cross-Over Studies ,business.industry ,food and beverages ,Oryza ,Original Articles ,Postprandial Period ,medicine.disease ,Medical Laboratory Technology ,Diabetes Mellitus, Type 1 ,Emergency medicine ,Smartphone ,business - 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.
- Published
- 2020
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