دورية أكاديمية
Frequency of hypoglycaemia with basal insulin treatments in adults with type 1 diabetes treated with basal-bolus insulin regimens in treat-to-target trials: A narrative review.
العنوان: | Frequency of hypoglycaemia with basal insulin treatments in adults with type 1 diabetes treated with basal-bolus insulin regimens in treat-to-target trials: A narrative review. |
---|---|
المؤلفون: | Russell-Jones D; The Cedar Centre, Royal Surrey NHS Foundation Trust, Guildford, UK.; Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK., Bailey TS; Endocrinology and Metabolism Institute, AMCR Institute, Escondido, California, USA., Lane W; Mountain Diabetes/Asheville Clinical Research, Asheville, North Carolina, USA., Mathieu C; Clinical and Experimental Endocrinology, University of Leuven, Leuven, Belgium., Pedersen-Bjergaard U; Department of Endocrinology and Nephrology, Nordsjællands Hospital Hillerød, University of Copenhagen, Hillerød, Denmark. |
المصدر: | Diabetic medicine : a journal of the British Diabetic Association [Diabet Med] 2024 Jul; Vol. 41 (7), pp. e15339. Date of Electronic Publication: 2024 Apr 28. |
نوع المنشور: | Journal Article; Review |
اللغة: | English |
بيانات الدورية: | Publisher: Blackwell Science Country of Publication: England NLM ID: 8500858 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1464-5491 (Electronic) Linking ISSN: 07423071 NLM ISO Abbreviation: Diabet Med Subsets: MEDLINE |
أسماء مطبوعة: | Publication: Oxford : Blackwell Science Original Publication: Chichester [Sussex, England] ; New York : Wiley, [c1984- |
مواضيع طبية MeSH: | Diabetes Mellitus, Type 1*/drug therapy , Diabetes Mellitus, Type 1*/blood , Hypoglycemia*/chemically induced , Hypoglycemia*/epidemiology , Hypoglycemic Agents*/administration & dosage , Hypoglycemic Agents*/adverse effects , Hypoglycemic Agents*/therapeutic use , Insulin*/administration & dosage , Insulin*/adverse effects , Insulin*/therapeutic use , Blood Glucose*/metabolism , Blood Glucose*/analysis, Humans ; Randomized Controlled Trials as Topic ; Adult ; Blood Glucose Self-Monitoring |
مستخلص: | Aim: To summarise, in a narrative review, published data on hypoglycaemia occurrence with basal insulin therapy in adults with type 1 diabetes treated with basal-bolus insulin regimens in treat-to-target randomised controlled trials. Methods: Data were included from 21 eligible trials, which mainly used self-measured blood glucose or plasma glucose to detect hypoglycaemia. Results: All-day self-measured blood glucose or plasma glucose level 2 (glucose threshold of 3.1 or 3.0 mmol/L) and level 3 (severe, requiring assistance) hypoglycaemic events were reported, respectively, by a range of 69.0%-97.5% and 0%-13.4% adults when receiving basal-bolus insulin therapy, with rates of 10.6-68.1 and 0.0-0.4 events per patient-year of exposure, respectively. Hypoglycaemia rates measured using continuous glucose monitoring (three studies) were numerically, yet consistently, higher than with either other method, except when limiting to symptomatic events. Nocturnal hypoglycaemia rates were generally less than 30% of the equivalent all-day rates. Conclusions: Differences across the studies in design (e.g., titration targets) and participant characteristics hindered comparison of hypoglycaemia rates by insulin formulation. Consequently, few trends were identified by insulin formulation, study methodology or individuals' characteristics, suggesting that further research is required to identify treatment strategies that facilitate development of individualised recommendations to lower hypoglycaemia risk. These findings are useful to understand hypoglycaemia risk with available basal insulin therapies when used in a multiple daily injection regimen, as well as to provide context for the results of ongoing and future clinical trials, including those for two once-weekly basal insulins, insulin icodec and basal insulin Fc. (© 2024 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.) |
References: | ElSayed NA, Aleppo G, Aroda VR, et al. 9. Pharmacologic approaches to glycemic treatment: standards of care in diabetes—2023. Diabetes Care. 2023;46(Suppl 1):S140‐S157. McCrimmon RJ, Sherwin RS. Hypoglycemia in type 1 diabetes. Diabetes. 2010;59(10):2333‐2339. Cryer PE. Hypoglycemia in type 1 diabetes mellitus. Endocrinol Metab Clin N Am. 2010;39(3):641‐654. ElSayed NA, Aleppo G, Aroda VR, et al. 6. Glycemic targets: standards of care in diabetes—2023. Diabetes Care. 2023;46(Suppl 1):S97‐S110. Holt RIG, DeVries JH, Hess‐Fischl A, et al. The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of diabetes (EASD). Diabetologia. 2021;64(12):2609‐2652. McCoy RG, Van Houten HK, Ziegenfuss JY, Shah ND, Wermers RA, Smith SA. Increased mortality of patients with diabetes reporting severe hypoglycemia. Diabetes Care. 2012;35(9):1897‐1901. Chatwin H, Broadley M, Jensen MV, et al. ‘Never again will I be carefree’: a qualitative study of the impact of hypoglycemia on quality of life among adults with type 1 diabetes. BMJ Open Diabetes Res Care. 2021;9(1):e002322. Garden GL, Hine JL, Mitchell SJ, et al. An evaluation of the safety of pilots with insulin‐treated diabetes in Europe flying commercial and noncommercial aircraft. Diabetes Care. 2020;43(12):2923‐2929. Battelino T, Edelman SV, Nishimura R, Bergenstal RM. Comparison of second‐generation basal insulin analogs: a review of the evidence from continuous glucose monitoring. Diabetes Technol Ther. 2021;23(1):20‐30. Pedersen‐Bjergaard U, Agesen RM, Brøsen J, et al. Comparison of treatment with insulin degludec and glargine U100 in patients with type 1 diabetes prone to nocturnal severe hypoglycaemia: the HypoDeg randomized, controlled, open‐label, crossover trial. Diabetes Obes Metab. 2022;24(2):257‐267. Kazda CM, Bue‐Valleskey JM, Chien J, et al. Novel once‐weekly basal insulin fc achieved similar glycemic control with a safety profile comparable to insulin degludec in patients with type 1 diabetes. Diabetes Care. 2023;46(5):1052‐1059. Rosenstock J, Bajaj HS, Janež A, et al. Once‐weekly insulin for type 2 diabetes without previous insulin treatment. N Engl J Med. 2020;383(22):2107‐2116. Bajaj HS, Bergenstal RM, Christoffersen A, et al. Switching to once‐weekly insulin icodec versus once‐daily insulin glargine U100 in type 2 diabetes inadequately controlled on daily basal insulin: a phase 2 randomized controlled trial. Diabetes Care. 2021;44(7):1586‐1594. Lingvay I, Buse JB, Franek E, et al. A randomized, open‐label comparison of once‐weekly insulin icodec titration strategies versus once‐daily insulin glargine U100. Diabetes Care. 2021;44(7):1595‐1603. Philis‐Tsimikas A, Bajaj HS, Begtrup K, et al. Rationale and design of the phase 3a development programme (ONWARDS 1–6 trials) investigating once‐weekly insulin icodec in diabetes. Diabetes Obes Metab. 2023;25(2):331‐341. Agesen RM, Kristensen PL, Beck‐Nielsen H, et al. Effect of insulin analogs on frequency of non–severe hypoglycemia in patients with type 1 diabetes prone to severe hypoglycemia: much higher rates detected by continuous glucose monitoring than by self‐monitoring of blood glucose—the HypoAna trial. Diabetes Technol Ther. 2018;20(3):247‐256. Brøsen JMB, Agesen RM, Alibegovic AC, et al. Continuous glucose monitoring‐recorded hypoglycemia with insulin degludec or insulin glargine U100 in people with type 1 diabetes prone to nocturnal severe hypoglycemia. Diabetes Technol Ther. 2022;24(9):643‐654. Lane W, Bailey TS, Gerety G, et al. Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 1 diabetes: the SWITCH 1 randomized clinical trial. JAMA. 2017;318(1):33‐44. Pedersen‐Bjergaard U, Kristensen PL, Beck‐Nielsen H, et al. Effect of insulin analogues on risk of severe hypoglycaemia in patients with type 1 diabetes prone to recurrent severe hypoglycaemia (HypoAna trial): a prospective, randomised, open‐label, blinded‐endpoint crossover trial. Lancet Diabetes Endocrinol. 2014;2(7):553‐561. Derosa G, Franzetti I, Querci F, Romano D, D'Angelo A, Maffioli P. Glucose‐lowering effect and glycaemic variability of insulin glargine, insulin detemir and insulin lispro protamine in people with type 1 diabetes. Diabetes Obes Metab. 2015;17(6):554‐559. Bergenstal RM, Lunt H, Franek E, et al. Randomized, double‐blind clinical trial comparing basal insulin peglispro and insulin glargine, in combination with prandial insulin lispro, in patients with type 1 diabetes: IMAGINE 3. Diabetes Obes Metab. 2016;18(11):1081‐1088. Garg S, Dreyer M, Jinnouchi H, et al. A randomized clinical trial comparing basal insulin peglispro and insulin glargine, in combination with prandial insulin lispro, in patients with type 1 diabetes: IMAGINE 1. Diabetes Obes Metab. 2016;18:25‐33. Davies M, Sasaki T, Gross JL, et al. Comparison of insulin degludec with insulin detemir in type 1 diabetes: a 1‐year treat‐to‐target trial. Diabetes Obes Metab. 2016;18(1):96‐99. Home PD, Bergenstal RM, Bolli GB, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 1 diabetes: a randomized, phase 3a, open‐label clinical trial (EDITION 4). Diabetes Care. 2015;38(12):2217‐2225. Bergenstal RM, Bailey TS, Rodbard D, et al. Comparison of insulin glargine 300 units/mL and 100 units/mL in adults with type 1 diabetes: continuous glucose monitoring profiles and variability using morning or evening injections. Diabetes Care. 2017;40(4):554‐560. Bode BW, Buse JB, Fisher M, et al. Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal–bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN®basal–bolus type 1): 2‐year results of a randomized clinical trial. Diabet Med. 2013;30(11):1293‐1297. Davies MJ, Gross JL, Ono Y, et al. Efficacy and safety of insulin degludec given as part of basal–bolus treatment with mealtime insulin aspart in type 1 diabetes: a 26‐week randomized, open‐label, treat‐to‐target non‐inferiority trial. Diabetes Obes Metab. 2014;16(10):922‐930. Heller S, Buse J, Fisher M, et al. Insulin degludec, an ultra‐longacting basal insulin, versus insulin glargine in basal‐bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN basal‐bolus type 1): a phase 3, randomised, open‐label, treat‐to‐target non‐inferiority trial. Lancet. 2012;379(9825):1489‐1497. Home PD, Meneghini L, Wendisch U, et al. Improved health status with insulin degludec compared with insulin glargine in people with type 1 diabetes. Diabet Med. 2012;29(6):716‐720. Home PD, Bergenstal RM, Bolli GB, et al. Glycaemic control and hypoglycaemia during 12 months of randomized treatment with insulin glargine 300 U/mL versus glargine 100 U/mL in people with type 1 diabetes (EDITION 4). Diabetes Obes Metab. 2018;20(1):121‐128. Mathieu C, Hollander P, Miranda‐Palma B, et al. Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: flex T1): a 26‐week randomized, treat‐to‐target trial with a 26‐week extension. J Clin Endocrinol Metab. 2013;98(3):1154‐1162. Matsuhisa M, Koyama M, Cheng X, et al. Sustained glycaemic control and less nocturnal hypoglycaemia with insulin glargine 300 U/mL compared with glargine 100 U/mL in Japanese adults with type 1 diabetes (EDITION JP 1 randomised 12‐month trial including 6‐month extension). Diabetes Res Clin Pract. 2016;122:133‐140. Matsuhisa M, Koyama M, Cheng X, et al. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1). Diabetes Obes Metab. 2016;18(4):375‐383. Pettus J, Gill J, Paranjape S, et al. Efficacy and safety of a morning injection of insulin glargine 300 units/mL versus insulin glargine 100 units/mL in adult patients with type 1 diabetes: a multicentre, randomized controlled trial using continuous glucose monitoring. Diabetes Obes Metab. 2019;21(8):1906‐1913. Battelino T, Danne T, Edelman SV, et al. Continuous glucose monitoring‐based time‐in‐range using insulin glargine 300 units/mL versus insulin degludec 100 units/mL in type 1 diabetes: the head‐to‐head randomized controlled InRange trial. Diabetes Obes Metab. 2023;25(2):545‐555. Takagi S, Miura J, Takita M, et al. Factors associated with hypoglycemia unawareness and severe hypoglycemia in type 1 diabetes mellitus patients. J Diabetes Investig. 2022;13(12):2018‐2026. ElSayed NA, Aleppo G, Aroda VR, et al. 13. Older adults: standards of care in diabetes—2023. Diabetes Care. 2023;46(Suppl 1):S216‐S229. American Diabetes Association Workgroup on Hypoglycemia. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association workgroup on hypoglycemia. Diabetes Care. 2005;28(5):1245‐1249. Cryer PE. Preventing hypoglycaemia: what is the appropriate glucose alert value? Diabetologia. 2009;52(1):35‐37. Frier BM. Defining hypoglycaemia: what level has clinical relevance? Diabetologia. 2009;52(1):31‐34. Erbach M, Freckmann G, Hinzmann R, et al. Interferences and limitations in blood glucose self‐testing: an overview of the current knowledge. J Diabetes Sci Technol. 2016;10(5):1161‐1168. International Hypogylcaemia Study Group. Glucose concentrations of less than 3.0 mmol/L (54 mg/dL) should Be reported in clinical trials: a joint position Statement of the American Diabetes Association and the European Association for the Study of diabetes. Diabetes Care. 2017;40(1):155‐157. Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J. Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care. 2011;34(4):795‐800. ElSayed NA, Aleppo G, Aroda VR, et al. 7. Diabetes technology: standards of care in diabetes—2023. Diabetes Care. 2023;46(Suppl 1):S111‐S127. Zimmerman C, Albanese‐O'Neill A, Haller MJ. Advances in type 1 diabetes technology over the last decade. Eur Endocrinol. 2019;15(2):70‐76. Dovc K, Battelino T. Evolution of diabetes technology. Endocrinol Metab Clin N Am. 2020;49(1):1‐18. |
معلومات مُعتمدة: | Novo Nordisk |
فهرسة مساهمة: | Keywords: diabetes mellitus; hypoglycaemia; insulin; type 1 |
المشرفين على المادة: | 0 (Hypoglycemic Agents) 0 (Insulin) 0 (Blood Glucose) |
تواريخ الأحداث: | Date Created: 20240429 Date Completed: 20240611 Latest Revision: 20240611 |
رمز التحديث: | 20240611 |
DOI: | 10.1111/dme.15339 |
PMID: | 38679910 |
قاعدة البيانات: | MEDLINE |
تدمد: | 1464-5491 |
---|---|
DOI: | 10.1111/dme.15339 |