Melissa H Lee1,2, Barbora Paldus1,2, Sara Vogrin1, Dale Morrison1, Dessi P Zaharieva3, Jean Lu1, Hannah M Jones1,2, Emma Netzer1, Lesley Robinson1, Benyamin Grosman4, Anirban Roy4, Natalie Kurtz4, Glenn M Ward2,5, Richard J MacIsaac1,2, Alicia J Jenkins1,2,6, David N O'Neal7,2. 1. Department of Medicine, University of Melbourne, Melbourne, Australia. 2. Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, Melbourne, Australia. 3. Division of Endocrinology, Department of Pediatrics, School of Medicine, Stanford University, Stanford, CA. 4. Medtronic, Northridge, CA. 5. Department of Pathology, University of Melbourne, Melbourne, Australia. 6. National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia. 7. Department of Medicine, University of Melbourne, Melbourne, Australia dno@unimelb.edu.au.
Abstract
OBJECTIVE: To evaluate glucose control using fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) delivered by the MiniMed Advanced Hybrid Closed-Loop (AHCL) system in adults with type 1 diabetes. RESEARCH DESIGN AND METHODS: In this randomized, open-label, crossover study, participants were assigned to receive faster aspart or IAsp in random order. Stages 1 and 2 comprised of 6 weeks in closed loop, preceded by 2 weeks in open loop. This was followed by stage 3, whereby participants changed directly back to the insulin formulation used in stage 1 for 1 week in closed loop. Participants chose their own meals except for two standardized meal tests, a missed meal bolus and late meal bolus. The primary outcome was the percentage of time sensor glucose values were from 70 to 180 mg/dL (time in range; [TIR]). RESULTS:Twenty-five adults (52% male) were recruited; the median (interquartile range) age was 48 (37, 57) years, and the median HbA1c was 7.0% (6.6, 7.2) (53 [49, 55] mmol/mol). Faster aspart demonstrated greater overall TIR compared with IAsp (82.3% [78.5, 83.7] vs. 79.6% [77.0, 83.4], respectively; mean difference 1.9% [0.5, 3.3]; P = 0.007). Four-hour postprandial glucose TIR was higher using faster aspart compared with IAsp for all meals combined (73.6% [69.4, 80.2] vs. 72.1% [64.5, 78.5], respectively; median difference 3.5% [1.0, 7.3]; P = 0.003). There was no ketoacidosis or severe hypoglycemia. CONCLUSIONS: Faster aspart safely improved glucose control compared with IAsp in a group of adults with well-controlled type 1 diabetes using AHCL. The modest improvement was mainly related to mealtime glycemia. While the primary outcome demonstrated statistical significance, the clinical impact may be small, given an overall difference in TIR of 1.9%.
RCT Entities:
OBJECTIVE: To evaluate glucose control using fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) delivered by the MiniMed Advanced Hybrid Closed-Loop (AHCL) system in adults with type 1 diabetes. RESEARCH DESIGN AND METHODS: In this randomized, open-label, crossover study, participants were assigned to receive faster aspart or IAsp in random order. Stages 1 and 2 comprised of 6 weeks in closed loop, preceded by 2 weeks in open loop. This was followed by stage 3, whereby participants changed directly back to the insulin formulation used in stage 1 for 1 week in closed loop. Participants chose their own meals except for two standardized meal tests, a missed meal bolus and late meal bolus. The primary outcome was the percentage of time sensor glucose values were from 70 to 180 mg/dL (time in range; [TIR]). RESULTS: Twenty-five adults (52% male) were recruited; the median (interquartile range) age was 48 (37, 57) years, and the median HbA1c was 7.0% (6.6, 7.2) (53 [49, 55] mmol/mol). Faster aspart demonstrated greater overall TIR compared with IAsp (82.3% [78.5, 83.7] vs. 79.6% [77.0, 83.4], respectively; mean difference 1.9% [0.5, 3.3]; P = 0.007). Four-hour postprandial glucose TIR was higher using faster aspart compared with IAsp for all meals combined (73.6% [69.4, 80.2] vs. 72.1% [64.5, 78.5], respectively; median difference 3.5% [1.0, 7.3]; P = 0.003). There was no ketoacidosis or severe hypoglycemia. CONCLUSIONS: Faster aspart safely improved glucose control compared with IAsp in a group of adults with well-controlled type 1 diabetes using AHCL. The modest improvement was mainly related to mealtime glycemia. While the primary outcome demonstrated statistical significance, the clinical impact may be small, given an overall difference in TIR of 1.9%.
Authors: Roy W Beck; Steven J Russell; Edward R Damiano; Firas H El-Khatib; Katrina J Ruedy; Courtney Balliro; Zoey Li; Peter Calhoun Journal: Diabetes Technol Ther Date: 2022-10 Impact factor: 7.337
Authors: Stuart A Weinzimer; Ryan J Bailey; Richard M Bergenstal; Revital Nimri; Roy W Beck; Desmond Schatz; Louise Ambler-Osborn; Darja Smigoc Schweiger; Thekla von dem Berge; Judy Sibayan; Mary L Johnson; Peter Calhoun; Moshe Phillip Journal: Diabetes Technol Ther Date: 2022-04-28 Impact factor: 7.337