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Outpatient Randomized Crossover Automated Insulin Delivery Versus Conventional Therapy with Induced Stress Challenges.
Kaur, Ravinder Jeet; Deshpande, Sunil; Pinsker, Jordan E; Gilliam, Wesley P; McCrady-Spitzer, Shelly; Zaniletti, Isabella; Desjardins, Donna; Church, Mei Mei; Doyle Iii, Francis J; Kremers, Walter K; Dassau, Eyal; Kudva, Yogish C.
Afiliación
  • Kaur RJ; Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota, USA.
  • Deshpande S; Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, Massachusetts, USA.
  • Pinsker JE; Sansum Diabetes Research Institute, Santa Barbara, California, USA.
  • Gilliam WP; Sansum Diabetes Research Institute, Santa Barbara, California, USA.
  • McCrady-Spitzer S; Department of Psychiatry, Mayo Clinic, Rochester, Minnesota, USA.
  • Zaniletti I; Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota, USA.
  • Desjardins D; Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA.
  • Church MM; Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota, USA.
  • Doyle Iii FJ; Sansum Diabetes Research Institute, Santa Barbara, California, USA.
  • Kremers WK; Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, Massachusetts, USA.
  • Dassau E; Sansum Diabetes Research Institute, Santa Barbara, California, USA.
  • Kudva YC; Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA.
Diabetes Technol Ther ; 24(5): 338-349, 2022 05.
Article en En | MEDLINE | ID: mdl-35049354
Background: Automated insulin delivery (AID) systems have not been evaluated in the context of psychological and pharmacological stress in type 1 diabetes. Our objective was to determine glycemic control and insulin use with Zone Model Predictive Control (zone-MPC) AID system enhanced for states of persistent hyperglycemia versus sensor-augmented pump (SAP) during outpatient use, including in-clinic induced stress. Materials and Methods: Randomized, crossover, 2-week trial of zone-MPC AID versus SAP in 14 adults with type 1 diabetes. In each arm, each participant was studied in-clinic with psychological stress induction (Trier Social Stress Test [TSST] and Socially Evaluated Cold Pressor Test [SECPT]), followed by pharmacological stress induction with oral hydrocortisone (total four sessions per participant). The main outcomes were 2-week continuous glucose monitor percent time in range (TIR) 70-180 mg/dL, and glucose and insulin outcomes during and overnight following stress induction. Results: During psychological stress, AID decreased glycemic variability percentage by 13.4% (P = 0.009). During pharmacological stress, including the following overnight, there were no differences in glucose outcomes and total insulin between AID and physician-assisted SAP. However, with AID total user-requested insulin was lower by 6.9 U (P = 0.01) for pharmacological stress. Stress induction was validated by changes in heart rate and salivary cortisol levels. During the 2-week AID use, TIR was 74.4% (vs. SAP 63.1%, P = 0.001) and overnight TIR was 78.3% (vs. SAP 63.1%, P = 0.004). There were no adverse events. Conclusions: Zone-MPC AID can reduce glycemic variability and the need for user-requested insulin during pharmacological stress and can improve overall glycemic outcomes. Clinical Trial Identifier NCT04142229.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 1 / Insulina Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adult / Humans Idioma: En Revista: Diabetes Technol Ther Asunto de la revista: ENDOCRINOLOGIA / TERAPEUTICA Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 1 / Insulina Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adult / Humans Idioma: En Revista: Diabetes Technol Ther Asunto de la revista: ENDOCRINOLOGIA / TERAPEUTICA Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos