Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes

被引：199

作者：

Brown, Sue A. ^{[1
]}

Forlenza, Gregory P. ^{[2
]}

Bode, Bruce W. ^{[3
]}

Pinsker, Jordan E. ^{[4
]}

Levy, Carol J. ^{[5
]}

Criego, Amy B. ^{[6
]}

Hansen, David W. ^{[7
]}

Hirsch, Irl B. ^{[8
]}

Carlson, Anders L. ^{[9
]}

Bergenstal, Richard M. ^{[9
]}

Sherr, Jennifer L. ^{[10
]}

Mehta, Sanjeev N. ^{[11
]}

Laffel, Lori M. ^{[11
]}

Shah, Viral N. ^{[2
]}

Bhargava, Anuj ^{[12
]}

Weinstock, Ruth S. ^{[13
]}

MacLeish, Sarah A. ^{[14
]}

DeSalvo, Daniel J. ^{[15
]}

Jones, Thomas C. ^{[16
]}

Aleppo, Grazia ^{[17
]}

Buckingham, Bruce A. ^{[18
]}

Ly, Trang T. ^{[19
]}

机构：

[1] Univ Virginia, Ctr Diabet Technol, Div Endocrinol, Charlottesville, VA USA

[2] Univ Colorado, Barbara Davis Ctr Diabet, Anschutz Med Campus, Aurora, CO USA

[3] Atlanta Diabet Associates, Atlanta, GA USA

[4] Sansum Diabet Res Inst, Santa Barbara, CA USA

[5] Icahn Sch Med Mt Sinai, New York, NY 10029 USA

[6] Pk Nicollet Pediat Endocrinol, Internat Diabet Ctr, Minneapolis, MN USA

[7] SUNY Upstate Med Univ, Dept Pediat, Syracuse, NY 13210 USA

[8] Univ Washington, Dept Med, Seattle, WA USA

[9] HealthPartners, Internat Diabet Ctr, Pk Nicollet, Minneapolis, MN USA

[10] Yale Sch Med, Dept Pediat, New Haven, CT USA

[11] Harvard Med Sch, Joslin Diabet Ctr, Boston, MA 02115 USA

[12] Iowa Diabet Res, Dept Res, W Des Moines, IA USA

[13] SUNY Upstate Med Univ, Dept Med, Syracuse, NY 13210 USA

[14] Rainbow Babies & Childrens Hosp, Dept Pediat, Univ Hosp Cleveland, Med Ctr, Cleveland, OH 44106 USA

[15] Baylor Coll Med, Dept Pediat, Houston, TX 77030 USA

[16] Jones Ctr, East Coast Inst Res, Dept Res, Macon, GA USA

[17] Northwestern Univ, Feinberg Sch Med, Chicago, IL 60611 USA

[18] Stanford Univ, Div Pediat Endocrinol, Dept Pediat, Stanford, CA 94305 USA

[19] Insulet Corp, Acton, MA 01720 USA

来源：

DIABETES CARE | 2021年 / 44卷 / 07期

关键词：

CLOSED-LOOP SYSTEM; SAFETY; PERFORMANCE; CHILDREN; GLUCOSE;

D O I：

10.2337/dc21-0172

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

OBJECTIVE Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets. RESEARCH DESIGN AND METHODS This single-arm, multicenter, prospective study enrolled 112 children (age 6-13.9 years) and 129 adults (age 14-70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA(1c) and percent time in sensor glucose range 70-180 mg/dL ("time in range"). RESULTS A total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study. HbA(1c) was significantly reduced in children by 0.71% (7.8 mmol/mol) (mean +/- SD: 7.67 +/- 0.95% to 6.99 +/- 0.63% [60 +/- 10.4 mmol/mol to 53 +/- 6.9 mmol/mol], P < 0.0001) and in adults by 0.38% (4.2 mmol/mol) (7.16 +/- 0.86% to 6.78 +/- 0.68% [55 +/- 9.4 mmol/mol to 51 +/- 7.4 mmol/mol], P < 0.0001). Time in range was improved from standard therapy by 15.6 +/- 11.5% or 3.7 h/day in children and 9.3 +/- 11.8% or 2.2 h/day in adults (both P < 0.0001). This was accomplished with a reduction in time in hypoglycemia <70 mg/dL among adults (median [interquartile range]: 2.00% [0.63, 4.06] to 1.09% [0.46, 1.75], P < 0.0001), while this parameter remained the same in children. There were three severe hypoglycemia events not attributable to automated insulin delivery malfunction and one diabetic ketoacidosis event from an infusion site failure. CONCLUSIONS This tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA(1c) levels and time in target glucose range with a very low occurrence of hypoglycemia.

引用

页码：1630 / 1640

页数：11

共 23 条

[1]

American Diabetes Association, 2020, DIABETES CARE, V43, pS66, DOI [DOI 10.2337/dc20-S006, 10.2337/dc20-S006]

[2] Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range [J].

Battelino, Tadej ;

Danne, Thomas ;

Bergenstal, Richard M. ;

Amiel, Stephanie A. ;

Beck, Roy ;

Biester, Torben ;

Bosi, Emanuele ;

Buckingham, Bruce A. ;

Cefalu, William T. ;

Close, Kelly L. ;

Cobelli, Claudio ;

Dassau, Eyal ;

DeVries, J. Hans ;

Donaghue, Kim C. ;

Dovc, Klemen ;

Doyle, Francis J. ;

Garg, Satish ;

Grunberger, George ;

Heller, Simon ;

Heinemann, Lutz ;

Hirsch, Irl B. ;

Hovorka, Roman ;

Jia, Weiping ;

Kordonouri, Olga ;

Kovatchev, Boris ;

Kowalski, Aaron ;

Laffel, Lori ;

Levine, Brian ;

Mayorov, Alexander ;

Mathieu, Chantal ;

Murphy, Helen R. ;

Nimri, Revital ;

Norgaard, Kirsten ;

Parkin, Christopher G. ;

Renard, Eric ;

Rodbard, David ;

Saboo, Banshi ;

Schatz, Desmond ;

Stoner, Keaton ;

Urakami, Tatsuiko ;

Weinzimer, Stuart A. ;

Phillip, Moshe .

DIABETES CARE, 2019, 42 (08) :1593-1603

[3] Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes [J].

Bergenstal, Richard M. ;

Garg, Satish ;

Weinzimer, Stuart A. ;

Buckingham, Bruce A. ;

Bode, Bruce W. ;

Tamborlane, William V. ;

Kaufman, Francine R. .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2016, 316 (13) :1407-1408

[4]

Berget Cari, 2019, Diabetes Spectr, V32, P194, DOI 10.2337/ds18-0091

[5] New closed-loop insulin systems [J].

Boughton, Charlotte K. ;

Hovorka, Roman .

DIABETOLOGIA, 2021, 64 (05) :1007-1015

[6] A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes [J].

Breton, Marc D. ;

Kanapka, Lauren G. ;

Beck, Roy W. ;

Ekhlaspour, Laya ;

Forlenza, Gregory P. ;

Cengiz, Eda ;

Schoelwer, Melissa ;

Ruedy, Katrina J. ;

Jost, Emily ;

Carria, Lori ;

Emory, Emma ;

Hsu, Liana J. ;

Oliveri, Mary ;

Kollman, Craig C. ;

Dokken, Betsy B. ;

Weinzimer, Stuart A. ;

DeBoer, Mark D. ;

Buckingham, Bruce A. ;

Chernavvsky, Daniel ;

Wadwa, R. Paul .

NEW ENGLAND JOURNAL OF MEDICINE, 2020, 383 (09) :836-845

[7] Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes [J].

Brown, S. A. ;

Kovatchev, B. P. ;

Raghinaru, D. ;

Lum, J. W. ;

Buckingham, B. A. ;

Kudva, Y. C. ;

Laffel, L. M. ;

Levy, C. J. ;

Pinsker, J. E. ;

Wadwa, R. P. ;

Dassau, E. ;

Doyle, F. J., III ;

Anderson, S. M. ;

Church, M. M. ;

Dadlani, V ;

Ekhlaspour, L. ;

Forlenza, G. P. ;

Isganaitis, E. ;

Lam, D. W. ;

Kollman, C. ;

Beck, R. W. .

NEW ENGLAND JOURNAL OF MEDICINE, 2019, 381 (18) :1707-1717

[8] Safety and Feasibility of the OmniPod Hybrid Closed-Loop System in Adult, Adolescent, and Pediatric Patients with Type 1 Diabetes Using a Personalized Model Predictive Control Algorithm [J].

Buckingham, Bruce A. ;

Forlenza, Gregory P. ;

Pinsker, Jordan E. ;

Christiansen, Mark P. ;

Wadwa, R. Paul ;

Schneider, Jennifer ;

Peyser, Thomas A. ;

Dassau, Eyal ;

Lee, Joon Bok ;

O'Connor, Jason ;

Layne, Jennifer E. ;

Ly, Trang T. .

DIABETES TECHNOLOGY & THERAPEUTICS, 2018, 20 (04) :257-262

[9] Performance of the Omnipod Personalized Model Predictive Control Algorithm with Meal Bolus Challenges in Adults with Type 1 Diabetes [J].

Buckingham, Bruce A. ;

Christiansen, Mark P. ;

Forlenza, Gregory P. ;

Wadwa, R. Paul ;

Peyser, Thomas A. ;

Lee, Joon Bok ;

O'Connor, Jason ;

Dassau, Eyal ;

Huyett, Lauren M. ;

Layne, Jennifer E. ;

Ly, Trang T. .

DIABETES TECHNOLOGY & THERAPEUTICS, 2018, 20 (09) :585-595

[10] EFFECT OF INTENSIVE DIABETES TREATMENT ON THE DEVELOPMENT AND PROGRESSION OF LONG-TERM COMPLICATIONS IN ADOLESCENTS WITH INSULIN-DEPENDENT DIABETES-MELLITUS - DIABETES CONTROL AND COMPLICATIONS TRIAL [J].

不详 .

JOURNAL OF PEDIATRICS, 1994, 125 (02) :177-188

← 1 2 3 →