OBJECTIVE: The objective of this study was to evaluate the safety and performance of the artificial pancreas (AP) in adolescents with type 1 diabetes (T1D) following insulin omission for food. RESEARCH DESIGN AND METHODS: In a randomized, cross-over trial, adolescents with T1D aged 13-18 yr were enrolled in a randomized, cross-over trial. On separate days, received either usual care (UC) through their home insulin pump or used an AP system (Diabetes Assistant platform, continuous glucose monitor, and insulin pump). Approximately 1 h after admission, participants in both groups received an unannounced snack of 30 g carbohydrate, and 4 h later they received an 80 g lunch, for which both groups only received 75% of the calculated insulin dose to cover carbohydrates. On the UC day (but not the AP day), they received their full high blood glucose (BG) correction factor at lunch. Each admission lasted approximately 8 h. RESULTS: A total of 16 participants completed the trial. On the AP day (compared to UC), mean BG was lower (197 ± 10 vs. 235 ± 14 mg/dL) and time in range 70-180 mg/dL was higher (43% ± 7 vs. 19% ± 7) (both p < 0.05) overall; these results held in the time following the snack and meal (also p < 0.05). During the trial, there were no differences between groups in the rate of hypoglycemia <70 mg/dL. CONCLUSIONS: The AP provided improvements in short-term glycemic control without increases in hypoglycemia following missed insulin for food in adolescents. Thus, the AP partly compensates for missed insulin boluses for food, a common occurrence in adolescent diabetes care. Further testing is needed in longer-term settings.
RCT Entities:
OBJECTIVE: The objective of this study was to evaluate the safety and performance of the artificial pancreas (AP) in adolescents with type 1 diabetes (T1D) following insulin omission for food. RESEARCH DESIGN AND METHODS: In a randomized, cross-over trial, adolescents with T1D aged 13-18 yr were enrolled in a randomized, cross-over trial. On separate days, received either usual care (UC) through their home insulin pump or used an AP system (Diabetes Assistant platform, continuous glucose monitor, and insulin pump). Approximately 1 h after admission, participants in both groups received an unannounced snack of 30 g carbohydrate, and 4 h later they received an 80 g lunch, for which both groups only received 75% of the calculated insulin dose to cover carbohydrates. On the UC day (but not the AP day), they received their full high blood glucose (BG) correction factor at lunch. Each admission lasted approximately 8 h. RESULTS: A total of 16 participants completed the trial. On the AP day (compared to UC), mean BG was lower (197 ± 10 vs. 235 ± 14 mg/dL) and time in range 70-180 mg/dL was higher (43% ± 7 vs. 19% ± 7) (both p < 0.05) overall; these results held in the time following the snack and meal (also p < 0.05). During the trial, there were no differences between groups in the rate of hypoglycemia <70 mg/dL. CONCLUSIONS: The AP provided improvements in short-term glycemic control without increases in hypoglycemia following missed insulin for food in adolescents. Thus, the AP partly compensates for missed insulin boluses for food, a common occurrence in adolescent diabetes care. Further testing is needed in longer-term settings.
Authors: Gregory P Forlenza; Faye M Cameron; Trang T Ly; David Lam; Daniel P Howsmon; Nihat Baysal; Georgia Kulina; Laurel Messer; Paula Clinton; Camilla Levister; Stephen D Patek; Carol J Levy; R Paul Wadwa; David M Maahs; B Wayne Bequette; Bruce A Buckingham Journal: Diabetes Technol Ther Date: 2018-04-16 Impact factor: 6.118
Authors: Stacey M Anderson; Eyal Dassau; Dan Raghinaru; John Lum; Sue A Brown; Jordan E Pinsker; Mei Mei Church; Carol Levy; David Lam; Yogish C Kudva; Bruce Buckingham; Gregory P Forlenza; R Paul Wadwa; Lori Laffel; Francis J Doyle; J Hans DeVries; Eric Renard; Claudio Cobelli; Federico Boscari; Simone Del Favero; Boris P Kovatchev Journal: Diabetes Technol Ther Date: 2019-01-16 Impact factor: 6.118
Authors: Laurel H Messer; Peter Calhoun; Bruce Buckingham; Darrell M Wilson; Irene Hramiak; Trang T Ly; Marsha Driscoll; Paula Clinton; David M Maahs Journal: Pediatr Diabetes Date: 2016-04-29 Impact factor: 4.866
Authors: Grenye O'Malley; Laurel H Messer; Carol J Levy; Jordan E Pinsker; Gregory P Forlenza; Elvira Isganaitis; Yogish C Kudva; Laya Ekhlaspour; Dan Raghinaru; John Lum; Sue A Brown Journal: Diabetes Technol Ther Date: 2021-04 Impact factor: 6.118
Authors: Laurel H Messer; Cari Berget; Ashlee Ernst; Lindsey Towers; Robert H Slover; Gregory P Forlenza Journal: Pediatr Diabetes Date: 2021-03-16 Impact factor: 4.866