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ASPIRE In-Home: rationale, design, and methods of a study to evaluate the safety and efficacy of automatic insulin suspension for nocturnal hypoglycemia.
Klonoff, David C; Bergenstal, Richard M; Garg, Satish K; Bode, Bruce W; Meredith, Melissa; Slover, Robert H; Ahmann, Andrew; Welsh, John B; Lee, Scott W.
Afiliação
  • Klonoff DC; Mills-Peninsula Health Services, San Mateo, CA 94401, USA. dklonoff@diabetestechnology.org
J Diabetes Sci Technol ; 7(4): 1005-10, 2013 Jul 01.
Article em En | MEDLINE | ID: mdl-23911183
ABSTRACT
Nocturnal hypoglycemia is a barrier to therapy intensification efforts in diabetes. The Paradigm® Veo™ system may mitigate nocturnal hypoglycemia by automatically suspending insulin when a prespecified sensor glucose threshold is reached. ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) In-Home (NCT01497938) was a multicenter, randomized, parallel, adaptive study of subjects with type 1 diabetes. The control arm used sensor-augmented pump therapy. The treatment arm used sensor-augmented pump therapy with threshold suspend, which automatically suspends the insulin pump in response to a sensor glucose value at or below a prespecified threshold. To be randomized, subjects had to have demonstrated ≥2 episodes of nocturnal hypoglycemia, defined as >20 consecutive minutes of sensor glucose values ≤65 mg/dl starting between 1000 PM and 800 AM in the 2-week run-in phase. The 3-month study phase evaluated safety by comparing changes in glycated hemoglobin (A1C) values and evaluated efficacy by comparing the mean area under the glucose concentration time curves for nocturnal hypoglycemia events in the two groups. Other outcomes included the rate of nocturnal hypoglycemia events and the distribution of sensor glucose values. Data from the ASPIRE In-Home study should provide evidence on the safety of the threshold suspend feature with respect to A1C and its efficacy with respect to severity and duration of nocturnal hypoglycemia when used at home over a 3-month period.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Sistemas de Infusão de Insulina / Diabetes Mellitus Tipo 1 / Serviços de Assistência Domiciliar / Hipoglicemia / Insulina Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Aged / Humans / Middle aged Idioma: En Ano de publicação: 2013 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Sistemas de Infusão de Insulina / Diabetes Mellitus Tipo 1 / Serviços de Assistência Domiciliar / Hipoglicemia / Insulina Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Aged / Humans / Middle aged Idioma: En Ano de publicação: 2013 Tipo de documento: Article