Closed-Loop Therapy and Preservation of C-Peptide Secretion in Type 1 Diabetes

• DOI: 10.1056/nejmoa2203496
• Publication Date: 2022-09-07T21:01:18Z
• Authors: Charlotte K. Boug...; Janet M. Allen; Julia Ware; Malgorzata E. Wil...; Sara Hartnell; Ajay Thankamony; Tabitha Randell; Atrayee Ghatak; Rachel E.J. Besser; Daniela Elleri; Nicola Trevelyan; Fiona M. Campbell; Judy Sibayan; Peter Calhoun; Ryan Bailey; Gareth Dunseath; Roman Hovorka
• Keywords: Interquartile range; Liter; C-peptide; Clinical endpoint

Whether improved glucose control with hybrid closed-loop therapy can preserve C-peptide secretion as compared standard insulin in persons new-onset type 1 diabetes is unclear.In a multicenter, open-label, parallel-group, randomized trial, we assigned youths 10.0 to 16.9 years of age within 21 days after diagnosis receive or (control) for 24 months. The primary end point was the area under curve (AUC) plasma level (after mixed-meal tolerance test) at 12 months diagnosis. analysis performed on an intention-to-treat basis.A total 97 participants (mean [±SD] age, 12±2 years) underwent randomization: 51 were and 46 therapy. AUC (primary point) did not differ significantly between two groups (geometric mean, 0.35 pmol per milliliter [interquartile range, 0.16 0.49] 0.46 0.22 0.69] therapy; mean adjusted difference, -0.06 [95% confidence interval {CI}, -0.14 0.03]). There substantial between-group difference 0.18 0.06 0.22] 0.24 0.05 0.30] -0.04 CI, 0.06]). arithmetic glycated hemoglobin lower group than by 4 mmol mole (0.4 percentage points; 95% 0 8 [0.0 0.7 points]) 11 (1.0 7 15 [0.5 1.5 Five cases severe hypoglycemia occurred (in 3 participants), one group; case diabetic ketoacidosis group.In diabetes, intensive appear prevent decline residual secretion. (Funded National Institute Health Care Research others; CLOuD ClinicalTrials.gov number, NCT02871089.).