Ahmad Haidar1, Laurent Legault2, Laurence Matteau-Pelletier3, Virginie Messier3, Maryse Dallaire3, Martin Ladouceur4, Rémi Rabasa-Lhoret5. 1. Institut de recherches cliniques de Montréal, Montreal, QC, Canada; Division of Experimental Medicine, Department of Medicine, McGill University, Montreal, QC, Canada. Electronic address: ahmad.haidar@mail.mcgill.ca. 2. Montreal Children's Hospital, McGill University Health Centre, Montreal, QC, Canada. 3. Institut de recherches cliniques de Montréal, Montreal, QC, Canada. 4. The Research Center of the Université de Montréal Hospital Center, Montreal, QC, Canada. 5. Institut de recherches cliniques de Montréal, Montreal, QC, Canada; Division of Experimental Medicine, Department of Medicine, McGill University, Montreal, QC, Canada; Nutrition Department, Faculty of Medicine, Université de Montréal, Montreal, QC, Canada; Montreal Diabetes Research Center, Montreal, QC, Canada.
Abstract
BACKGROUND: Additional benefits of the dual-hormone (insulin and glucagon) artificial pancreas compared with the single-hormone (insulin alone) artificial pancreas have not been assessed in young people in outpatient unrestricted conditions. We evaluated the efficacy of three systems for nocturnal glucose control in children and adolescents with type 1 diabetes. METHODS: We did a randomised, three-way, crossover trial in children aged 9-17 years with type 1 diabetes attending a diabetes camp in Canada. With use of sealed envelopes, children were randomly assigned in a 1:1:1:1:1:1 ratio with blocks of six to different sequences of the three interventions (single-hormone artificial pancreas, dual-hormone artificial pancreas, and conventional continuous subcutaneous insulin pump therapy). Each intervention was applied for 3 consecutive nights. Participants, study staff, and endpoint assessors were not masked. The primary outcome was the percentage of time spent with glucose concentrations lower than 4·0 mmol/L from 2300 h to 0700 h. Analysis was by intention to treat. A p value of less than 0·0167 was regarded as significant. This study is registered with ClinicalTrials.gov, number NCT02189694. FINDINGS:Between June 30, 2014, and Aug 9, 2014, we enrolled 33 children of mean age 13·3 years (SD 2·3; range 9-17). The time spent at a glucose concentration lower than 4·0 mmol/L was median 0% (IQR 0·0-2·4) during nights with the dual-hormone artificial pancreas, 3·1% (0·0-6·9) during nights with the single-hormone artificial pancreas (p=0·032), and 3·4% (0-11·0) during nights with conventional pump therapy (p=0·0048 compared with dual-hormone artificial pancreas and p=0·32 compared with single-hormone artificial pancreas). 15 hypoglycaemic events (<3·1 mmol/L for 20 min measured by sensor then confirmed with capillary glucose <4·0 mmol/L) were noted during nights with conventional pump therapy compared with four events with the single-hormone system and no events with the dual-hormone system. None of the assessed outcomes varied with the order in which children and young adults were assigned interventions. INTERPRETATION: The dual-hormone artificial pancreas could improve nocturnal glucose control in children and adolescents with type 1 diabetes. Longer and larger outpatient studies are now needed. FUNDING: Canadian Diabetes Association, Fondation J A De Sève.
RCT Entities:
BACKGROUND: Additional benefits of the dual-hormone (insulin and glucagon) artificial pancreas compared with the single-hormone (insulin alone) artificial pancreas have not been assessed in young people in outpatient unrestricted conditions. We evaluated the efficacy of three systems for nocturnal glucose control in children and adolescents with type 1 diabetes. METHODS: We did a randomised, three-way, crossover trial in children aged 9-17 years with type 1 diabetes attending a diabetescamp in Canada. With use of sealed envelopes, children were randomly assigned in a 1:1:1:1:1:1 ratio with blocks of six to different sequences of the three interventions (single-hormone artificial pancreas, dual-hormone artificial pancreas, and conventional continuous subcutaneous insulin pump therapy). Each intervention was applied for 3 consecutive nights. Participants, study staff, and endpoint assessors were not masked. The primary outcome was the percentage of time spent with glucose concentrations lower than 4·0 mmol/L from 2300 h to 0700 h. Analysis was by intention to treat. A p value of less than 0·0167 was regarded as significant. This study is registered with ClinicalTrials.gov, number NCT02189694. FINDINGS: Between June 30, 2014, and Aug 9, 2014, we enrolled 33 children of mean age 13·3 years (SD 2·3; range 9-17). The time spent at a glucose concentration lower than 4·0 mmol/L was median 0% (IQR 0·0-2·4) during nights with the dual-hormone artificial pancreas, 3·1% (0·0-6·9) during nights with the single-hormone artificial pancreas (p=0·032), and 3·4% (0-11·0) during nights with conventional pump therapy (p=0·0048 compared with dual-hormone artificial pancreas and p=0·32 compared with single-hormone artificial pancreas). 15 hypoglycaemic events (<3·1 mmol/L for 20 min measured by sensor then confirmed with capillary glucose <4·0 mmol/L) were noted during nights with conventional pump therapy compared with four events with the single-hormone system and no events with the dual-hormone system. None of the assessed outcomes varied with the order in which children and young adults were assigned interventions. INTERPRETATION: The dual-hormone artificial pancreas could improve nocturnal glucose control in children and adolescents with type 1 diabetes. Longer and larger outpatient studies are now needed. FUNDING: Canadian Diabetes Association, Fondation J A De Sève.
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: Firas H El-Khatib; Courtney Balliro; Mallory A Hillard; Kendra L Magyar; Laya Ekhlaspour; Manasi Sinha; Debbie Mondesir; Aryan Esmaeili; Celia Hartigan; Michael J Thompson; Samir Malkani; J Paul Lock; David M Harlan; Paula Clinton; Eliana Frank; Darrell M Wilson; Daniel DeSalvo; Lisa Norlander; Trang Ly; Bruce A Buckingham; Jamie Diner; Milana Dezube; Laura A Young; April Goley; M Sue Kirkman; John B Buse; Hui Zheng; Rajendranath R Selagamsetty; Edward R Damiano; Steven J Russell Journal: Lancet Date: 2016-12-20 Impact factor: 79.321