Hood Thabit1, Sara Hartnell2, Janet M Allen3, Andrea Lake4, Malgorzata E Wilinska3, Yue Ruan3, Mark L Evans1, Anthony P Coll1, Roman Hovorka5. 1. Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Wolfson Diabetes Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK. 2. Wolfson Diabetes Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK. 3. Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Department of Paediatrics, University of Cambridge, Cambridge, UK. 4. Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK. 5. Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Department of Paediatrics, University of Cambridge, Cambridge, UK. Electronic address: rh347@cam.ac.uk.
Abstract
BACKGROUND: We assessed whether fully closed-loop insulin delivery (the so-called artificial pancreas) is safe and effective compared with standard subcutaneous insulin therapy in patients with type 2 diabetes in the general ward. METHODS: For this single-centre, open-label, parallel-group, randomised controlled trial, we enrolled patients aged 18 years or older with type 2 diabetes who were receivinginsulin therapy. Patients were recruited from general wards at Addenbrooke's Hospital, Cambridge, UK. Participants were randomly assigned (1:1) by a computer-generated minimisation method to receive closed-loop insulin delivery (using a model-predictive control algorithm to direct subcutaneous delivery of rapid-acting insulin analogue without meal-time insulin boluses) or conventional subcutaneous insulin delivery according to local clinical guidelines. The primary outcome was time spent in the target glucose concentration range of 5·6-10·0 mmol/L during the 72 h study period. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01774565. FINDINGS:Between Feb 20, 2015, and March 24, 2016, we enrolled 40 participants, of whom 20 were randomly assigned to the closed-loop intervention group and 20 to the control group. The proportion of time spent in the target glucose range was 59·8% (SD 18·7) in the closed-loop group and 38·1% (16·7) in the control group (difference 21·8% [95% CI 10·4-33·1]; p=0·0004). No episodes of severe hypoglycaemia or hyperglycaemia with ketonaemia occurred in either group. One adverse event unrelated to study devices occurred during the study (gastrointestinal bleed). INTERPRETATION:Closed-loop insulin delivery without meal-time boluses is effective and safe in insulin-treated adults with type 2 diabetes in the general ward. FUNDING: Diabetes UK; European Foundation for the Study of Diabetes; JDRF; National Institute for Health Research Cambridge Biomedical Research Centre; Wellcome Trust.
RCT Entities:
BACKGROUND: We assessed whether fully closed-loop insulin delivery (the so-called artificial pancreas) is safe and effective compared with standard subcutaneous insulin therapy in patients with type 2 diabetes in the general ward. METHODS: For this single-centre, open-label, parallel-group, randomised controlled trial, we enrolled patients aged 18 years or older with type 2 diabetes who were receiving insulin therapy. Patients were recruited from general wards at Addenbrooke's Hospital, Cambridge, UK. Participants were randomly assigned (1:1) by a computer-generated minimisation method to receive closed-loop insulin delivery (using a model-predictive control algorithm to direct subcutaneous delivery of rapid-acting insulin analogue without meal-time insulin boluses) or conventional subcutaneous insulin delivery according to local clinical guidelines. The primary outcome was time spent in the target glucose concentration range of 5·6-10·0 mmol/L during the 72 h study period. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01774565. FINDINGS: Between Feb 20, 2015, and March 24, 2016, we enrolled 40 participants, of whom 20 were randomly assigned to the closed-loop intervention group and 20 to the control group. The proportion of time spent in the target glucose range was 59·8% (SD 18·7) in the closed-loop group and 38·1% (16·7) in the control group (difference 21·8% [95% CI 10·4-33·1]; p=0·0004). No episodes of severe hypoglycaemia or hyperglycaemia with ketonaemia occurred in either group. One adverse event unrelated to study devices occurred during the study (gastrointestinal bleed). INTERPRETATION: Closed-loop insulin delivery without meal-time boluses is effective and safe in insulin-treated adults with type 2 diabetes in the general ward. FUNDING: Diabetes UK; European Foundation for the Study of Diabetes; JDRF; National Institute for Health Research Cambridge Biomedical Research Centre; Wellcome Trust.
Authors: Georgia M Davis; Rodolfo J Galindo; Alexandra L Migdal; Guillermo E Umpierrez Journal: Endocrinol Metab Clin North Am Date: 2020-03 Impact factor: 4.741
Authors: Rodolfo J Galindo; Guillermo E Umpierrez; Robert J Rushakoff; Ananda Basu; Suzanne Lohnes; James H Nichols; Elias K Spanakis; Juan Espinoza; Nadine E Palermo; Dessa Garnett Awadjie; Leigh Bak; Bruce Buckingham; Curtiss B Cook; Guido Freckmann; Lutz Heinemann; Roman Hovorka; Nestoras Mathioudakis; Tonya Newman; David N O'Neal; Michaela Rickert; David B Sacks; Jane Jeffrie Seley; Amisha Wallia; Trisha Shang; Jennifer Y Zhang; Julia Han; David C Klonoff Journal: J Diabetes Sci Technol Date: 2020-09-28