التفاصيل البيبلوغرافية
| العنوان: |
Closed-Loop Therapy and Preservation of C-Peptide Secretion in Type 1 Diabetes. |
| المؤلفون: |
Boughton, Charlotte K.1,2, Allen, Janet M.1,3, Ware, Julia1,3, Wilinska, Malgorzata E.1,3, Hartnell, Sara2, Thankamony, Ajay1, Randell, Tabitha4, Ghatak, Atrayee3,5, Besser, Rachel E. J.6, Elleri, Daniela7, Trevelyan, Nicola8, Campbell, Fiona M.9, Sibayan, Judy10, Calhoun, Peter10, Bailey, Ryan10, Dunseath, Gareth11, Hovorka, Roman1,3 rh347@cam.ac.uk, CLOuD Consortium |
| المصدر: |
New England Journal of Medicine. 9/8/2022, Vol. 387 Issue 10, p882-893. 12p. |
| مصطلحات موضوعية: |
*BLOOD sugar analysis, *INSULIN therapy, *RESEARCH, *RESEARCH methodology, *TYPE 1 diabetes, *HYPOGLYCEMIC agents, *EVALUATION research, *COMPARATIVE studies, *RANDOMIZED controlled trials, *INSULIN pumps, *C-peptide |
| مستخلص: |
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.). [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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