The Transition of Time in Range, Basal Insulin Dose, and Insulin Sensitivity after Introducing a Hybrid Closed Loop of MiniMed 770G in Outpatients with Type 1 Diabetes in Real World Cohort Study
Introduction: MiniMed 770G is a new insulin pump equipped with Hybrid Closed Loop (HCL). Its clinical impact on the actual clinical user in Japanese adolescents is still unclear. Material and methods: We compared glucose profiles, including HbA1c, Time in Range (TIR), and insulin dose in patients wi...
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| Published in | Journal of the Japan Innovative Diabetes Treatment Vol. 17; no. 1; pp. 1 - 14 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | Japanese |
| Published |
Association for the study of Innovative Diabetes Treatment in Japan
2023
日本先進糖尿病治療研究会 |
| Subjects | |
| Online Access | Get full text |
| ISSN | 2436-0058 |
| DOI | 10.34612/asindtj.17.1_1 |
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| Abstract | Introduction: MiniMed 770G is a new insulin pump equipped with Hybrid Closed Loop (HCL). Its clinical impact on the actual clinical user in Japanese adolescents is still unclear. Material and methods: We compared glucose profiles, including HbA1c, Time in Range (TIR), and insulin dose in patients with established type 1 diabetes mellitus who had already used Continuous Glucose Monitoring before the HCL introduction.Results: Results: Thirty-seven participants were included in the analysis. The median age was 15 years (Median values are used below). Before and three months after HCL introduction, HbA1c significantly decreased from 7.51% to 7.08%, and TIR significantly increased from 60.4% to 69.6%, respectively. Basal insulin as a percentage of total daily insulin dose (Basal%) showed an increasing trend from 32.3% to 37.0%. The stratified analysis revealed that the group with increased Basal% had a significantly lower Basal% before HCL introduction than the group with decreased Basal%. Younger age group showed a significant insulin sensitivity discrepancy of more than 100 between the calculated and the default setting before HCL introduction.Conclusion: HbA1c and TIR improved after HCL introduction, and the basal% showed an increasing trend. Insulin sensitivity of some younger age group deviated after the HCL introduction, suggesting a risk of hypoglycemia due to HCL. |
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| AbstractList | Introduction: MiniMed 770G is a new insulin pump equipped with Hybrid Closed Loop (HCL). Its clinical impact on the actual clinical user in Japanese adolescents is still unclear. Material and methods: We compared glucose profiles, including HbA1c, Time in Range (TIR), and insulin dose in patients with established type 1 diabetes mellitus who had already used Continuous Glucose Monitoring before the HCL introduction.Results: Results: Thirty-seven participants were included in the analysis. The median age was 15 years (Median values are used below). Before and three months after HCL introduction, HbA1c significantly decreased from 7.51% to 7.08%, and TIR significantly increased from 60.4% to 69.6%, respectively. Basal insulin as a percentage of total daily insulin dose (Basal%) showed an increasing trend from 32.3% to 37.0%. The stratified analysis revealed that the group with increased Basal% had a significantly lower Basal% before HCL introduction than the group with decreased Basal%. Younger age group showed a significant insulin sensitivity discrepancy of more than 100 between the calculated and the default setting before HCL introduction.Conclusion: HbA1c and TIR improved after HCL introduction, and the basal% showed an increasing trend. Insulin sensitivity of some younger age group deviated after the HCL introduction, suggesting a risk of hypoglycemia due to HCL.
【緒言】本邦における実臨床下でのHybrid Closed Loop(以下HCLと略す)を搭載したミニメド770Gの、有用性に関する情報は乏しい。【方法】インスリンポンプ治療中で、Sensor Augmented PumpやContinuous Glucose Monitoringを使用し、ミニメド770Gを導入した1型糖尿病患者を対象に、導入前後での、特にTime in Range(以下TIRと略す)やインスリン使用量の変化を検討した。【結果】37名が解析対象。年齢は平均22.8歳。導入前と導入3か月後の比較では、HbA1cは7.51％から7.08％と有意に低下し、TIRは60.4％から69.6％へ有意に増加した。総インスリン投与量に占める基礎インスリン量の割合(以下Basal％と略す)は導入前32.3％、導入後37.0％と増加傾向を認めたが、層別解析で、Basal％が増加していた群は、減少群と比して導入前のBasal％が有意に低かった。Auto mode計算効果値が導入前の効果値よりも100以上小さい症例が4例あった。【結論】HCL導入後、HbA1cやTIRは改善した。Basal％は全体に増加傾向であった。特に低年齢層で、計算効果値と元の効果値が乖離して、HCLによる低血糖リスクが示唆された。 Introduction: MiniMed 770G is a new insulin pump equipped with Hybrid Closed Loop (HCL). Its clinical impact on the actual clinical user in Japanese adolescents is still unclear. Material and methods: We compared glucose profiles, including HbA1c, Time in Range (TIR), and insulin dose in patients with established type 1 diabetes mellitus who had already used Continuous Glucose Monitoring before the HCL introduction.Results: Results: Thirty-seven participants were included in the analysis. The median age was 15 years (Median values are used below). Before and three months after HCL introduction, HbA1c significantly decreased from 7.51% to 7.08%, and TIR significantly increased from 60.4% to 69.6%, respectively. Basal insulin as a percentage of total daily insulin dose (Basal%) showed an increasing trend from 32.3% to 37.0%. The stratified analysis revealed that the group with increased Basal% had a significantly lower Basal% before HCL introduction than the group with decreased Basal%. Younger age group showed a significant insulin sensitivity discrepancy of more than 100 between the calculated and the default setting before HCL introduction.Conclusion: HbA1c and TIR improved after HCL introduction, and the basal% showed an increasing trend. Insulin sensitivity of some younger age group deviated after the HCL introduction, suggesting a risk of hypoglycemia due to HCL. |
| Author | Yuyama, Yoshihiko Hamazaki, Takashi Kawamura, Tomoyuki Hotta, Yuko Naoko, Naoko-Nakamura |
| Author_FL | 濱崎 考史 堀田 優子 柚山 賀彦 西川 直子 川村 智行 |
| Author_FL_xml | – sequence: 1 fullname: 柚山 賀彦 – sequence: 2 fullname: 川村 智行 – sequence: 3 fullname: 堀田 優子 – sequence: 4 fullname: 西川 直子 – sequence: 5 fullname: 濱崎 考史 |
| Author_xml | – sequence: 1 fullname: Yuyama, Yoshihiko organization: Division of Pediatrics, Osaka Metropolitan University Graduate School, Osaka, Japan – sequence: 1 fullname: Kawamura, Tomoyuki organization: Abeno Medical Clinic, Osaka, Japan – sequence: 1 fullname: Hotta, Yuko organization: Division of Pediatrics, Kashiwara Municipal Hospital, Osaka, Japan – sequence: 1 fullname: Naoko, Naoko-Nakamura organization: Division of Pediatrics, Osaka Metropolitan University Graduate School, Osaka, Japan – sequence: 1 fullname: Hamazaki, Takashi organization: Division of Pediatrics, Osaka Metropolitan University Graduate School, Osaka, Japan |
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| DocumentTitle_FL | 外来通院中１型糖尿病患者へミニメド770G Hybrid Closed Loopを導入した前後での基礎インスリン投与量、Time in Rangeおよび効果値の変化 |
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| References | 15) Danne T, Von SW, Lange K, Nestoris C, Datz N, Kordonouri O (2006) Current practice of insulin pump therapy in children and adolescents - the Hannover recipe. Pediatric Diabetes.2006;7:25-31. 13) Danne T, Phillip M, Buckingham B A, Przemyslawa J-C, Saboo B, Urakami T, Battelino T, Hanas R, Codner E (2018) ISPAD Clinical Practice Consensus Guidelines 2018: Insulin treatment in children and adolescents with diabetes. Pediatr Diabetes. 2018;19 Suppl 27:115-135. 16) 広瀬正和, 川村智行, 東出崇, 木村佳代, 稲田浩, 青野繁雄, 新平鎮博, 山野恒一 (2007) 乳児期発症の糖尿病患者にCSII療法とカーボカウント法を導入し有効であった3症例. 糖尿病.2007;50:811-817. 17) Arslanian S, Kim J Y, Nasr A, Bacha F, Tfayli H, Lee S, Toledo F G S (2018) Insulin sensitivity across the lifespan from obese adolescents to obese adults with impaired glucose tolerance: Who is worse off? Pediatr Diabetes. 2018;19:205-211. 4) Roberts A, Fried L, Dart J, De B M, Fairchild J, King B, Ambler G R, Cameron F, McAuley S A, Keech A C, Jenkins A, O’Neal, D N, Davis E A, Jones T W, Abraham M B(2022) Hybrid closed‐loop therapy with a first‐generation system increases confidence and independence in diabetes management in youth with type 1 diabetes. Diabet Med.2022;39:e14907. 5) World Health Organization (1999) Definition, diagnosis and classification of diabetes mellitus and its complications : report of a WHO consultation. Part 1, Diagnosis and classification of diabetes mellitus, World Health Organization, Geneva (https://apps.who.int/iris/handle/10665/66040) (最終アクセス2022年12月5日 6) Thomas A, Heinemann L (2022) Algorithms for Automated Insulin Delivery: An Overview. J Diabetes Sci Technol. 2022;16:1228-1238. 10) Hashimoto T, Kawamura T, Kashihara Y, Hirose M, Higashide T, Tsuruhara A, Fujimoto H, Noi K, Shintaku H (2012) Factors associated with basal insulin dose in Japanese children and young adult type 1 diabetics. J Diabetes Investig. 2012;3:276-282. 1) Miller K M, Foster N C, Beck R W, Bergenstal R M, DuBose S N, DiMeglio L A, Maahs D M, Tamborlane W V(2015) Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015;38:971-978. 8) Biester T, Kordonouri O, Holder M, Remus K, Kieninger-Baum D, Wadien T, Danne T(2017) “Let the Algorithm Do the Work”: Reduction of Hypoglycemia Using Sensor-Augmented Pump Therapy with Predictive Insulin Suspension (SmartGuard) in Pediatric Type 1 Diabetes Patients. Diabetes Technol Ther. 2017;19:173-182. 7) Usoh C O, Johnson C P, Speiser J L, Bundy R, Dharod A, Aloi J A (2022) Real-World Efficacy of the Hybrid Closed-Loop System. J Diabetes Sci Technol. 2022;16:659-662. 14) Hanas R, Adolfsson P (2017) Bolus Calculator Settings in Well-Controlled Prepubertal Children Using Insulin Pumps Are Characterized by Low Insulin to Carbohydrate Ratios and Short Duration of Insulin Action Time. J Diabetes Sci Technol. 2017;11:247-252. 18) Hegab A M (2022) Diurnal Variation of Real-Life Insulin Sensitivity Factor Among Children and Adolescents With Type 1 Diabetes Using Ultra-Long-Acting Basal Insulin Analogs. Front Pediatr.2022; 10:854972. 3) Garg S K, Weinzimer S A., Tamborlane W V, Buckingham B A, Bode B W, Bailey T S, Brazg R L, Ilany J, Slover R H, Anderson S M, Bergenstal R M, Grosman B, Roy A, Cordero T L, Shin J, Lee S W, Kaufman F R (2017) Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes. Diabetes Techno Ther. 2017;19:155-163. 11) Walsh J, Roberts R, Bailey T(2010) Guidelines for Insulin Dosing in Continuous Subcutaneous Insulin Infusion Using New Formulas from a Retrospective Study of Individuals with Optimal Glucose Levels. J Diabetes Sci Technol. 2010;4:1174-1181. 2) Messer L H, Berget C, Vigers T, Pyle L, Geno C, Wadwa R P, Driscoll K A, Forlenza G P (2020) Real world hybrid closed‐loop discontinuation: Predictors and perceptions of youth discontinuing the 670G system in the first 6 months. Pediatr Diabetes. 2020;21:319-327. 12) King AB, Kuroda A, Matsuhisa M, Hobbs T (2016) A Review of Insulin-Dosing Formulas for Continuous Subcutaneous Insulin Infusion (CSII) for Adults with Type 1 Diabetes. Curr Diab Rep. 2016:16:83. 9) Kuroda A, Kaneto H, Yasuda T, Matsuhisa M, Miyashita K, Fujiki N, Fujisawa K, Yamamoto T, Takahara M, Sakamoto F, Matsuoka TA, Shimomura I (2011) Basal insulin requirement is ~30% of the total daily insulin dose in type 1 diabetic patients who use the insulin pump. Diabetes Care.2011;34:1089-1090. |
| References_xml | – reference: 18) Hegab A M (2022) Diurnal Variation of Real-Life Insulin Sensitivity Factor Among Children and Adolescents With Type 1 Diabetes Using Ultra-Long-Acting Basal Insulin Analogs. Front Pediatr.2022; 10:854972. – reference: 7) Usoh C O, Johnson C P, Speiser J L, Bundy R, Dharod A, Aloi J A (2022) Real-World Efficacy of the Hybrid Closed-Loop System. J Diabetes Sci Technol. 2022;16:659-662. – reference: 12) King AB, Kuroda A, Matsuhisa M, Hobbs T (2016) A Review of Insulin-Dosing Formulas for Continuous Subcutaneous Insulin Infusion (CSII) for Adults with Type 1 Diabetes. Curr Diab Rep. 2016:16:83. – reference: 15) Danne T, Von SW, Lange K, Nestoris C, Datz N, Kordonouri O (2006) Current practice of insulin pump therapy in children and adolescents - the Hannover recipe. Pediatric Diabetes.2006;7:25-31. – reference: 8) Biester T, Kordonouri O, Holder M, Remus K, Kieninger-Baum D, Wadien T, Danne T(2017) “Let the Algorithm Do the Work”: Reduction of Hypoglycemia Using Sensor-Augmented Pump Therapy with Predictive Insulin Suspension (SmartGuard) in Pediatric Type 1 Diabetes Patients. Diabetes Technol Ther. 2017;19:173-182. – reference: 13) Danne T, Phillip M, Buckingham B A, Przemyslawa J-C, Saboo B, Urakami T, Battelino T, Hanas R, Codner E (2018) ISPAD Clinical Practice Consensus Guidelines 2018: Insulin treatment in children and adolescents with diabetes. Pediatr Diabetes. 2018;19 Suppl 27:115-135. – reference: 9) Kuroda A, Kaneto H, Yasuda T, Matsuhisa M, Miyashita K, Fujiki N, Fujisawa K, Yamamoto T, Takahara M, Sakamoto F, Matsuoka TA, Shimomura I (2011) Basal insulin requirement is ~30% of the total daily insulin dose in type 1 diabetic patients who use the insulin pump. Diabetes Care.2011;34:1089-1090. – reference: 6) Thomas A, Heinemann L (2022) Algorithms for Automated Insulin Delivery: An Overview. J Diabetes Sci Technol. 2022;16:1228-1238. – reference: 17) Arslanian S, Kim J Y, Nasr A, Bacha F, Tfayli H, Lee S, Toledo F G S (2018) Insulin sensitivity across the lifespan from obese adolescents to obese adults with impaired glucose tolerance: Who is worse off? Pediatr Diabetes. 2018;19:205-211. – reference: 16) 広瀬正和, 川村智行, 東出崇, 木村佳代, 稲田浩, 青野繁雄, 新平鎮博, 山野恒一 (2007) 乳児期発症の糖尿病患者にCSII療法とカーボカウント法を導入し有効であった3症例. 糖尿病.2007;50:811-817. – reference: 5) World Health Organization (1999) Definition, diagnosis and classification of diabetes mellitus and its complications : report of a WHO consultation. Part 1, Diagnosis and classification of diabetes mellitus, World Health Organization, Geneva (https://apps.who.int/iris/handle/10665/66040) (最終アクセス2022年12月5日) – reference: 14) Hanas R, Adolfsson P (2017) Bolus Calculator Settings in Well-Controlled Prepubertal Children Using Insulin Pumps Are Characterized by Low Insulin to Carbohydrate Ratios and Short Duration of Insulin Action Time. J Diabetes Sci Technol. 2017;11:247-252. – reference: 4) Roberts A, Fried L, Dart J, De B M, Fairchild J, King B, Ambler G R, Cameron F, McAuley S A, Keech A C, Jenkins A, O’Neal, D N, Davis E A, Jones T W, Abraham M B(2022) Hybrid closed‐loop therapy with a first‐generation system increases confidence and independence in diabetes management in youth with type 1 diabetes. Diabet Med.2022;39:e14907. – reference: 10) Hashimoto T, Kawamura T, Kashihara Y, Hirose M, Higashide T, Tsuruhara A, Fujimoto H, Noi K, Shintaku H (2012) Factors associated with basal insulin dose in Japanese children and young adult type 1 diabetics. J Diabetes Investig. 2012;3:276-282. – reference: 3) Garg S K, Weinzimer S A., Tamborlane W V, Buckingham B A, Bode B W, Bailey T S, Brazg R L, Ilany J, Slover R H, Anderson S M, Bergenstal R M, Grosman B, Roy A, Cordero T L, Shin J, Lee S W, Kaufman F R (2017) Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes. Diabetes Techno Ther. 2017;19:155-163. – reference: 1) Miller K M, Foster N C, Beck R W, Bergenstal R M, DuBose S N, DiMeglio L A, Maahs D M, Tamborlane W V(2015) Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015;38:971-978. – reference: 11) Walsh J, Roberts R, Bailey T(2010) Guidelines for Insulin Dosing in Continuous Subcutaneous Insulin Infusion Using New Formulas from a Retrospective Study of Individuals with Optimal Glucose Levels. J Diabetes Sci Technol. 2010;4:1174-1181. – reference: 2) Messer L H, Berget C, Vigers T, Pyle L, Geno C, Wadwa R P, Driscoll K A, Forlenza G P (2020) Real world hybrid closed‐loop discontinuation: Predictors and perceptions of youth discontinuing the 670G system in the first 6 months. Pediatr Diabetes. 2020;21:319-327. |
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| SubjectTerms | 1型糖尿病 Hybrid Closed Loop Insulin Sensitivity Minimed770G Time in Range Type1 Diabetes インスリン効果値 ミニメド770G |
| Title | The Transition of Time in Range, Basal Insulin Dose, and Insulin Sensitivity after Introducing a Hybrid Closed Loop of MiniMed 770G in Outpatients with Type 1 Diabetes in Real World Cohort Study |
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