Mary B Abraham1,2, Jennifer A Nicholas1,3, Grant J Smith3, Janice M Fairchild4, Bruce R King5, Geoffrey R Ambler6, Fergus J Cameron7, Elizabeth A Davis1,2, Timothy W Jones8,2. 1. Children's Diabetes Centre, Telethon Kids Institute, The University of Western Australia, Perth, Australia. 2. Division of Paediatrics, Medical School, The University of Western Australia, Perth, Australia. 3. Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Australia. 4. Department of Endocrinology and Diabetes, Women's and Children's Hospital, Adelaide, Australia. 5. Department of Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, Australia. 6. Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead and Clinical School, The University of Sydney, Sydney, Australia. 7. Department of Endocrinology and Diabetes, The Royal Children's Hospital, Melbourne, Australia. 8. Children's Diabetes Centre, Telethon Kids Institute, The University of Western Australia, Perth, Australia tim.jones@health.wa.gov.au.
Abstract
OBJECTIVE: Short-term studies with automated systems that suspend basal insulin when hypoglycemia is predicted have shown a reduction in hypoglycemia; however, efficacy and safety have not been established in long-term trials. RESEARCH DESIGN AND METHODS: We conducted a 6-month, multicenter, randomized controlled trial in children and adolescents with type 1 diabetes using theMedtronic MiniMed 640G pump with Suspend before low (predictive low-glucose management [PLGM]) compared with sensor-augmented pump therapy (SAPT) alone. The primary outcome was percentage time in hypoglycemia with sensor glucose (SG) <3.5 mmol/L (63 mg/dL). RESULTS: In an intent-to-treat analysis of 154 subjects, 74 subjects were randomized to SAPT and 80 subjects to PLGM. At baseline, the time with SG <3.5 mmol/L was 3.0% and 2.8% in the SAPT and PLGM groups, respectively. During the study, PLGM was associated with a reduction in hypoglycemia compared with SAPT (% time SG <3.5 mmol/L: SAPT vs. PLGM, 2.6 vs. 1.5, P < 0.0001). A similar effect was also noted in time with SG <3 mmol/L (P < 0.0001). This reduction was seen both during day and night (P < 0.0001). Hypoglycemic events (SG <3.5 mmol/L for >20 min) also declined with PLGM (SAPT vs. PLGM: events/patient-year 227 vs. 139, P < 0.001). There was no difference in glycated hemoglobin (HbA1c) at 6 months (SAPT 7.6 ± 1.0% vs. PLGM 7.8 ± 0.8%, P = 0.35). No change in quality of life measures was reported by participants/parents in either group. There were no PLGM-related serious adverse events. CONCLUSIONS: In children and adolescents with type 1 diabetes, PLGM reduced hypoglycemia without deterioration in glycemic control.
RCT Entities:
OBJECTIVE: Short-term studies with automated systems that suspend basal insulin when hypoglycemia is predicted have shown a reduction in hypoglycemia; however, efficacy and safety have not been established in long-term trials. RESEARCH DESIGN AND METHODS: We conducted a 6-month, multicenter, randomized controlled trial in children and adolescents with type 1 diabetes using the Medtronic MiniMed 640G pump with Suspend before low (predictive low-glucose management [PLGM]) compared with sensor-augmented pump therapy (SAPT) alone. The primary outcome was percentage time in hypoglycemia with sensor glucose (SG) <3.5 mmol/L (63 mg/dL). RESULTS: In an intent-to-treat analysis of 154 subjects, 74 subjects were randomized to SAPT and 80 subjects to PLGM. At baseline, the time with SG <3.5 mmol/L was 3.0% and 2.8% in the SAPT and PLGM groups, respectively. During the study, PLGM was associated with a reduction in hypoglycemia compared with SAPT (% time SG <3.5 mmol/L: SAPT vs. PLGM, 2.6 vs. 1.5, P < 0.0001). A similar effect was also noted in time with SG <3 mmol/L (P < 0.0001). This reduction was seen both during day and night (P < 0.0001). Hypoglycemic events (SG <3.5 mmol/L for >20 min) also declined with PLGM (SAPT vs. PLGM: events/patient-year 227 vs. 139, P < 0.001). There was no difference in glycated hemoglobin (HbA1c) at 6 months (SAPT 7.6 ± 1.0% vs. PLGM 7.8 ± 0.8%, P = 0.35). No change in quality of life measures was reported by participants/parents in either group. There were no PLGM-related serious adverse events. CONCLUSIONS: In children and adolescents with type 1 diabetes, PLGM reduced hypoglycemia without deterioration in glycemic control.
Authors: Sue A Brown; Boris P Kovatchev; Dan Raghinaru; John W Lum; Bruce A Buckingham; Yogish C Kudva; Lori M Laffel; Carol J Levy; Jordan E Pinsker; R Paul Wadwa; Eyal Dassau; Francis J Doyle; Stacey M Anderson; Mei Mei Church; Vikash Dadlani; Laya Ekhlaspour; Gregory P Forlenza; Elvira Isganaitis; David W Lam; Craig Kollman; Roy W Beck Journal: N Engl J Med Date: 2019-10-16 Impact factor: 91.245
Authors: Sue A Brown; Roy W Beck; Dan Raghinaru; Bruce A Buckingham; Lori M Laffel; R Paul Wadwa; Yogish C Kudva; Carol J Levy; Jordan E Pinsker; Eyal Dassau; Francis J Doyle; Louise Ambler-Osborn; Stacey M Anderson; Mei Mei Church; Laya Ekhlaspour; Gregory P Forlenza; Camilla Levister; Vinaya Simha; Marc D Breton; Craig Kollman; John W Lum; Boris P Kovatchev Journal: Diabetes Care Date: 2020-05-29 Impact factor: 19.112
Authors: Carlos G Juan; Héctor García; Ernesto Ávila-Navarro; Enrique Bronchalo; Vicente Galiano; Óscar Moreno; Domingo Orozco; José María Sabater-Navarro Journal: Med Biol Eng Comput Date: 2019-08-31 Impact factor: 2.602