{"doi":"10.1056/nejmoa2203496","title":"Closed-Loop Therapy and Preservation of C-Peptide Secretion in Type 1 Diabetes","abstract":"BACKGROUND: Whether improved glucose control with hybrid closed-loop therapy can preserve C-peptide secretion as compared with standard insulin therapy in persons with new-onset type 1 diabetes is unclear. METHODS: In a multicenter, open-label, parallel-group, randomized trial, we assigned youths 10.0 to 16.9 years of age within 21 days after a diagnosis of type 1 diabetes to receive hybrid closed-loop therapy or standard insulin therapy (control) for 24 months. The primary end point was the area under the curve (AUC) for the plasma C-peptide level (after a mixed-meal tolerance test) at 12 months after diagnosis. The analysis was performed on an intention-to-treat basis. RESULTS: A total of 97 participants (mean [±SD] age, 12±2 years) underwent randomization: 51 were assigned to receive closed-loop therapy and 46 to receive control therapy. The AUC for the C-peptide level at 12 months (primary end point) did not differ significantly between the two groups (geometric mean, 0.35 pmol per milliliter [interquartile range, 0.16 to 0.49] with closed-loop therapy and 0.46 pmol per milliliter [interquartile range, 0.22 to 0.69] with control therapy; mean adjusted difference, -0.06 pmol per milliliter [95% confidence interval {CI}, -0.14 to 0.03]). There was not a substantial between-group difference in the AUC for the C-peptide level at 24 months (geometric mean, 0.18 pmol per milliliter [interquartile range, 0.06 to 0.22] with closed-loop therapy and 0.24 pmol per milliliter [interquartile range, 0.05 to 0.30] with control therapy; mean adjusted difference, -0.04 pmol per milliliter [95% CI, -0.14 to 0.06]). The arithmetic mean glycated hemoglobin level was lower in the closed-loop group than in the control group by 4 mmol per mole (0.4 percentage points; 95% CI, 0 to 8 mmol per mole [0.0 to 0.7 percentage points]) at 12 months and by 11 mmol per mole (1.0 percentage points; 95% CI, 7 to 15 mmol per mole [0.5 to 1.5 percentage points]) at 24 months. Five cases of severe hypoglycemia occurred in the closed-loop group (in 3 participants), and one occurred in the control group; one case of diabetic ketoacidosis occurred in the closed-loop group. CONCLUSIONS: In youths with new-onset type 1 diabetes, intensive glucose control for 24 months did not appear to prevent the decline in residual C-peptide secretion. (Funded by the National Institute for Health and Care Research and others; CLOuD ClinicalTrials.gov number, NCT02871089.).","journal":"New England Journal of Medicine","year":2022,"id":234135,"datarank":2.985917213321394,"base_score":4.672828834461906,"endowment":4.672828834461906,"self_citation_contribution":0.7009243251692859,"citation_network_contribution":2.284992888152108,"self_endowment_contribution":0.7009243251692859,"citer_contribution":2.284992888152108,"corpus_percentile":null,"corpus_rank":null,"citation_count":106,"citer_count":85,"citers_with_citation_signal":66,"citers_with_endowment":66,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9562,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02871089"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":850190,"name":"Janet M. 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Wilinska","orcid":"0000-0002-1564-8083","position":3,"is_corresponding":false},{"id":849357,"name":"Sara Hartnell","orcid":"0009-0002-8957-7924","position":4,"is_corresponding":false},{"id":849358,"name":"Ajay Thankamony","orcid":"0000-0001-6290-3553","position":5,"is_corresponding":false},{"id":849359,"name":"Tabitha Randell","orcid":"0000-0002-1703-1589","position":6,"is_corresponding":false},{"id":850192,"name":"Atrayee Ghatak","orcid":null,"position":7,"is_corresponding":false},{"id":637088,"name":"Rachel Besser","orcid":"0000-0002-4645-6324","position":8,"is_corresponding":false},{"id":850193,"name":"Daniela Elleri","orcid":null,"position":9,"is_corresponding":false},{"id":849360,"name":"Nicola Trevelyan","orcid":"0000-0002-5991-2691","position":10,"is_corresponding":false},{"id":849361,"name":"Fiona Campbell","orcid":"0000-0002-7618-6759","position":11,"is_corresponding":false},{"id":849362,"name":"Judy Sibayan","orcid":"0009-0005-9298-133X","position":12,"is_corresponding":false},{"id":486362,"name":"Peter Calhoun","orcid":"0000-0002-5325-7200","position":13,"is_corresponding":false},{"id":849363,"name":"Ryan Bailey","orcid":"0000-0001-5763-4598","position":14,"is_corresponding":false},{"id":849364,"name":"Gareth Dunseath","orcid":"0000-0001-6022-862X","position":15,"is_corresponding":false},{"id":742423,"name":"Roman Hovorka","orcid":"0000-0003-2901-461X","position":16,"is_corresponding":false},{"id":849355,"name":"Charlotte K. 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