Randomized Trial of the Insulin-Only iLet Bionic Pancreas for the Treatment of Cystic Fibrosis- Related Diabetes
Cystic fibrosis-related diabetes (CFRD) affects up to 50% of adults with cystic fibrosis and adds significant morbidity and treatment burden. We evaluated the safety and efficacy of automated insulin delivery with the iLet bionic pancreas (BP) in adults with CFRD in a single-center, open-label, rand...
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| Veröffentlicht in: | Diabetes care 2024-01, Vol.47 (1), p.101-108 |
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| creator | Sherwood, Jordan S Castellanos, Luz E O'Connor, Mollie Y Balliro, Courtney A Hillard, Mallory A Gaston, Sarah Grace Bartholomew, Rachel Greaux, Evelyn Sabean, Amy Zheng, Hui Marchetti, Peter Uluer, Ahmet Sawicki, Gregory S Neuringer, Isabel El-Khatib, Firas H Damiano, Edward R Russell, Steven J Putman, Melissa S |
| description | Cystic fibrosis-related diabetes (CFRD) affects up to 50% of adults with cystic fibrosis and adds significant morbidity and treatment burden. We evaluated the safety and efficacy of automated insulin delivery with the iLet bionic pancreas (BP) in adults with CFRD in a single-center, open-label, random-order, crossover trial.
Twenty participants with CFRD were assigned in random order to 14 days each on the BP or their usual care (UC). No restrictions were placed on diet or activity. The primary outcome was the percent time sensor-measured glucose was in target range 70-180 mg/dL (time in range [TIR]) on days 3-14 of each arm, and key secondary outcomes included mean continuous glucose monitoring (CGM) glucose and the percent time sensor-measured glucose was in hypoglycemic range |
| doi_str_mv | 10.2337/dc23-1411 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10733649</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2881711033</sourcerecordid><originalsourceid>FETCH-LOGICAL-c369t-f5a93b49f1833b3831d50ddb7f26e27e1db767a70be24313cca05818f9471e7d3</originalsourceid><addsrcrecordid>eNpdkUFvFCEYhonR2LV68A-YSbzoYSrMxyxwMnW1tskmNc16JgzzjaWZgRUYk_XXl7G1qZ6A8PDk_XgJec3oSQMgPvS2gZpxxp6QFVPQ1m3L5VOyooyrulWqOSIvUrqhlHIu5XNyBEIKrqRYkf2V8X2Y3G_sq110ZqzCUOVrrC58mkfn60s_Hiq3xVx9csE7W30z3kY0qRpC_EPuyilP6PPydHNIuUBnroshuVRXVziaXOSfnekwY3pJng1mTPjqfj0m38--7Dbn9fby68XmdFtbWKtcD61R0HE1MAnQgQTWt7TvOzE0a2wEsrJdCyNohw0HBtYa2komB8UFQ9HDMfl4593P3YS9LfmiGfU-usnEgw7G6X9vvLvWP8IvzagAWHNVDO_uDTH8nDFlPblkcRyNxzAn3UjJBGMUoKBv_0Nvwhx9mU83ihau-Bbh-zvKlr9JEYeHNIzqpUi9FKmXIgv75nH8B_Jvc3ALzW6Y4g</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2908816499</pqid></control><display><type>article</type><title>Randomized Trial of the Insulin-Only iLet Bionic Pancreas for the Treatment of Cystic Fibrosis- Related Diabetes</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><creator>Sherwood, Jordan S ; Castellanos, Luz E ; O'Connor, Mollie Y ; Balliro, Courtney A ; Hillard, Mallory A ; Gaston, Sarah Grace ; Bartholomew, Rachel ; Greaux, Evelyn ; Sabean, Amy ; Zheng, Hui ; Marchetti, Peter ; Uluer, Ahmet ; Sawicki, Gregory S ; Neuringer, Isabel ; El-Khatib, Firas H ; Damiano, Edward R ; Russell, Steven J ; Putman, Melissa S</creator><creatorcontrib>Sherwood, Jordan S ; Castellanos, Luz E ; O'Connor, Mollie Y ; Balliro, Courtney A ; Hillard, Mallory A ; Gaston, Sarah Grace ; Bartholomew, Rachel ; Greaux, Evelyn ; Sabean, Amy ; Zheng, Hui ; Marchetti, Peter ; Uluer, Ahmet ; Sawicki, Gregory S ; Neuringer, Isabel ; El-Khatib, Firas H ; Damiano, Edward R ; Russell, Steven J ; Putman, Melissa S</creatorcontrib><description>Cystic fibrosis-related diabetes (CFRD) affects up to 50% of adults with cystic fibrosis and adds significant morbidity and treatment burden. We evaluated the safety and efficacy of automated insulin delivery with the iLet bionic pancreas (BP) in adults with CFRD in a single-center, open-label, random-order, crossover trial.
Twenty participants with CFRD were assigned in random order to 14 days each on the BP or their usual care (UC). No restrictions were placed on diet or activity. The primary outcome was the percent time sensor-measured glucose was in target range 70-180 mg/dL (time in range [TIR]) on days 3-14 of each arm, and key secondary outcomes included mean continuous glucose monitoring (CGM) glucose and the percent time sensor-measured glucose was in hypoglycemic range <54 mg/dL.
TIR was significantly higher in the BP arm than the UC arm (75 ± 11% vs. 62 ± 22%, P = 0.001). Mean CGM glucose was lower in the BP arm than in the UC arm (150 ± 19 vs. 171 ± 45 mg/dL, P = 0.007). There was no significant difference in percent time with sensor-measured glucose <54 mg/dL (0.27% vs. 0.36%, P = 1.0), although self-reported symptomatic hypoglycemia episodes were higher during the BP arm than the UC arm (0.7 vs. 0.4 median episodes per day, P = 0.01). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either arm.
Adults with CFRD had improved glucose control without an increase in CGM-measured hypoglycemia with the BP compared with their UC, suggesting that this may be an important therapeutic option for this patient population.</description><identifier>ISSN: 0149-5992</identifier><identifier>ISSN: 1935-5548</identifier><identifier>EISSN: 1935-5548</identifier><identifier>DOI: 10.2337/dc23-1411</identifier><identifier>PMID: 37874987</identifier><language>eng</language><publisher>United States: American Diabetes Association</publisher><subject>Adult ; Adults ; Bionics ; Blood Glucose ; Blood Glucose Self-Monitoring ; Cystic fibrosis ; Cystic Fibrosis - drug therapy ; Diabetes ; Diabetes mellitus ; Diabetes Mellitus, Type 1 - drug therapy ; Glucose ; Glucose monitoring ; Humans ; Hypoglycemia ; Hypoglycemia - drug therapy ; Hypoglycemic Agents - therapeutic use ; Insulin ; Insulin - therapeutic use ; Insulin Infusion Systems ; Insulin, Regular, Human - therapeutic use ; Ketoacidosis ; Morbidity ; Original ; Pancreas ; Sensors ; Time measurement</subject><ispartof>Diabetes care, 2024-01, Vol.47 (1), p.101-108</ispartof><rights>2023 by the American Diabetes Association.</rights><rights>Copyright American Diabetes Association Jan 2024</rights><rights>2023 by the American Diabetes Association 2023</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c369t-f5a93b49f1833b3831d50ddb7f26e27e1db767a70be24313cca05818f9471e7d3</citedby><cites>FETCH-LOGICAL-c369t-f5a93b49f1833b3831d50ddb7f26e27e1db767a70be24313cca05818f9471e7d3</cites><orcidid>0000-0002-7655-8954</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37874987$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sherwood, Jordan S</creatorcontrib><creatorcontrib>Castellanos, Luz E</creatorcontrib><creatorcontrib>O'Connor, Mollie Y</creatorcontrib><creatorcontrib>Balliro, Courtney A</creatorcontrib><creatorcontrib>Hillard, Mallory A</creatorcontrib><creatorcontrib>Gaston, Sarah Grace</creatorcontrib><creatorcontrib>Bartholomew, Rachel</creatorcontrib><creatorcontrib>Greaux, Evelyn</creatorcontrib><creatorcontrib>Sabean, Amy</creatorcontrib><creatorcontrib>Zheng, Hui</creatorcontrib><creatorcontrib>Marchetti, Peter</creatorcontrib><creatorcontrib>Uluer, Ahmet</creatorcontrib><creatorcontrib>Sawicki, Gregory S</creatorcontrib><creatorcontrib>Neuringer, Isabel</creatorcontrib><creatorcontrib>El-Khatib, Firas H</creatorcontrib><creatorcontrib>Damiano, Edward R</creatorcontrib><creatorcontrib>Russell, Steven J</creatorcontrib><creatorcontrib>Putman, Melissa S</creatorcontrib><title>Randomized Trial of the Insulin-Only iLet Bionic Pancreas for the Treatment of Cystic Fibrosis- Related Diabetes</title><title>Diabetes care</title><addtitle>Diabetes Care</addtitle><description>Cystic fibrosis-related diabetes (CFRD) affects up to 50% of adults with cystic fibrosis and adds significant morbidity and treatment burden. We evaluated the safety and efficacy of automated insulin delivery with the iLet bionic pancreas (BP) in adults with CFRD in a single-center, open-label, random-order, crossover trial.
Twenty participants with CFRD were assigned in random order to 14 days each on the BP or their usual care (UC). No restrictions were placed on diet or activity. The primary outcome was the percent time sensor-measured glucose was in target range 70-180 mg/dL (time in range [TIR]) on days 3-14 of each arm, and key secondary outcomes included mean continuous glucose monitoring (CGM) glucose and the percent time sensor-measured glucose was in hypoglycemic range <54 mg/dL.
TIR was significantly higher in the BP arm than the UC arm (75 ± 11% vs. 62 ± 22%, P = 0.001). Mean CGM glucose was lower in the BP arm than in the UC arm (150 ± 19 vs. 171 ± 45 mg/dL, P = 0.007). There was no significant difference in percent time with sensor-measured glucose <54 mg/dL (0.27% vs. 0.36%, P = 1.0), although self-reported symptomatic hypoglycemia episodes were higher during the BP arm than the UC arm (0.7 vs. 0.4 median episodes per day, P = 0.01). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either arm.
Adults with CFRD had improved glucose control without an increase in CGM-measured hypoglycemia with the BP compared with their UC, suggesting that this may be an important therapeutic option for this patient population.</description><subject>Adult</subject><subject>Adults</subject><subject>Bionics</subject><subject>Blood Glucose</subject><subject>Blood Glucose Self-Monitoring</subject><subject>Cystic fibrosis</subject><subject>Cystic Fibrosis - drug therapy</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes Mellitus, Type 1 - drug therapy</subject><subject>Glucose</subject><subject>Glucose monitoring</subject><subject>Humans</subject><subject>Hypoglycemia</subject><subject>Hypoglycemia - drug therapy</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Insulin</subject><subject>Insulin - therapeutic use</subject><subject>Insulin Infusion Systems</subject><subject>Insulin, Regular, Human - therapeutic use</subject><subject>Ketoacidosis</subject><subject>Morbidity</subject><subject>Original</subject><subject>Pancreas</subject><subject>Sensors</subject><subject>Time measurement</subject><issn>0149-5992</issn><issn>1935-5548</issn><issn>1935-5548</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkUFvFCEYhonR2LV68A-YSbzoYSrMxyxwMnW1tskmNc16JgzzjaWZgRUYk_XXl7G1qZ6A8PDk_XgJec3oSQMgPvS2gZpxxp6QFVPQ1m3L5VOyooyrulWqOSIvUrqhlHIu5XNyBEIKrqRYkf2V8X2Y3G_sq110ZqzCUOVrrC58mkfn60s_Hiq3xVx9csE7W30z3kY0qRpC_EPuyilP6PPydHNIuUBnroshuVRXVziaXOSfnekwY3pJng1mTPjqfj0m38--7Dbn9fby68XmdFtbWKtcD61R0HE1MAnQgQTWt7TvOzE0a2wEsrJdCyNohw0HBtYa2komB8UFQ9HDMfl4593P3YS9LfmiGfU-usnEgw7G6X9vvLvWP8IvzagAWHNVDO_uDTH8nDFlPblkcRyNxzAn3UjJBGMUoKBv_0Nvwhx9mU83ihau-Bbh-zvKlr9JEYeHNIzqpUi9FKmXIgv75nH8B_Jvc3ALzW6Y4g</recordid><startdate>20240101</startdate><enddate>20240101</enddate><creator>Sherwood, Jordan S</creator><creator>Castellanos, Luz E</creator><creator>O'Connor, Mollie Y</creator><creator>Balliro, Courtney A</creator><creator>Hillard, Mallory A</creator><creator>Gaston, Sarah Grace</creator><creator>Bartholomew, Rachel</creator><creator>Greaux, Evelyn</creator><creator>Sabean, Amy</creator><creator>Zheng, Hui</creator><creator>Marchetti, Peter</creator><creator>Uluer, Ahmet</creator><creator>Sawicki, Gregory S</creator><creator>Neuringer, Isabel</creator><creator>El-Khatib, Firas H</creator><creator>Damiano, Edward R</creator><creator>Russell, Steven J</creator><creator>Putman, Melissa S</creator><general>American Diabetes Association</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-7655-8954</orcidid></search><sort><creationdate>20240101</creationdate><title>Randomized Trial of the Insulin-Only iLet Bionic Pancreas for the Treatment of Cystic Fibrosis- Related Diabetes</title><author>Sherwood, Jordan S ; Castellanos, Luz E ; O'Connor, Mollie Y ; Balliro, Courtney A ; Hillard, Mallory A ; Gaston, Sarah Grace ; Bartholomew, Rachel ; Greaux, Evelyn ; Sabean, Amy ; Zheng, Hui ; Marchetti, Peter ; Uluer, Ahmet ; Sawicki, Gregory S ; Neuringer, Isabel ; El-Khatib, Firas H ; Damiano, Edward R ; Russell, Steven J ; Putman, Melissa S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c369t-f5a93b49f1833b3831d50ddb7f26e27e1db767a70be24313cca05818f9471e7d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adult</topic><topic>Adults</topic><topic>Bionics</topic><topic>Blood Glucose</topic><topic>Blood Glucose Self-Monitoring</topic><topic>Cystic fibrosis</topic><topic>Cystic Fibrosis - drug therapy</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes Mellitus, Type 1 - drug therapy</topic><topic>Glucose</topic><topic>Glucose monitoring</topic><topic>Humans</topic><topic>Hypoglycemia</topic><topic>Hypoglycemia - drug therapy</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Insulin</topic><topic>Insulin - therapeutic use</topic><topic>Insulin Infusion Systems</topic><topic>Insulin, Regular, Human - therapeutic use</topic><topic>Ketoacidosis</topic><topic>Morbidity</topic><topic>Original</topic><topic>Pancreas</topic><topic>Sensors</topic><topic>Time measurement</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sherwood, Jordan S</creatorcontrib><creatorcontrib>Castellanos, Luz E</creatorcontrib><creatorcontrib>O'Connor, Mollie Y</creatorcontrib><creatorcontrib>Balliro, Courtney A</creatorcontrib><creatorcontrib>Hillard, Mallory A</creatorcontrib><creatorcontrib>Gaston, Sarah Grace</creatorcontrib><creatorcontrib>Bartholomew, Rachel</creatorcontrib><creatorcontrib>Greaux, Evelyn</creatorcontrib><creatorcontrib>Sabean, Amy</creatorcontrib><creatorcontrib>Zheng, Hui</creatorcontrib><creatorcontrib>Marchetti, Peter</creatorcontrib><creatorcontrib>Uluer, Ahmet</creatorcontrib><creatorcontrib>Sawicki, Gregory S</creatorcontrib><creatorcontrib>Neuringer, Isabel</creatorcontrib><creatorcontrib>El-Khatib, Firas H</creatorcontrib><creatorcontrib>Damiano, Edward R</creatorcontrib><creatorcontrib>Russell, Steven J</creatorcontrib><creatorcontrib>Putman, Melissa S</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Diabetes care</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sherwood, Jordan S</au><au>Castellanos, Luz E</au><au>O'Connor, Mollie Y</au><au>Balliro, Courtney A</au><au>Hillard, Mallory A</au><au>Gaston, Sarah Grace</au><au>Bartholomew, Rachel</au><au>Greaux, Evelyn</au><au>Sabean, Amy</au><au>Zheng, Hui</au><au>Marchetti, Peter</au><au>Uluer, Ahmet</au><au>Sawicki, Gregory S</au><au>Neuringer, Isabel</au><au>El-Khatib, Firas H</au><au>Damiano, Edward R</au><au>Russell, Steven J</au><au>Putman, Melissa S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized Trial of the Insulin-Only iLet Bionic Pancreas for the Treatment of Cystic Fibrosis- Related Diabetes</atitle><jtitle>Diabetes care</jtitle><addtitle>Diabetes Care</addtitle><date>2024-01-01</date><risdate>2024</risdate><volume>47</volume><issue>1</issue><spage>101</spage><epage>108</epage><pages>101-108</pages><issn>0149-5992</issn><issn>1935-5548</issn><eissn>1935-5548</eissn><abstract>Cystic fibrosis-related diabetes (CFRD) affects up to 50% of adults with cystic fibrosis and adds significant morbidity and treatment burden. We evaluated the safety and efficacy of automated insulin delivery with the iLet bionic pancreas (BP) in adults with CFRD in a single-center, open-label, random-order, crossover trial.
Twenty participants with CFRD were assigned in random order to 14 days each on the BP or their usual care (UC). No restrictions were placed on diet or activity. The primary outcome was the percent time sensor-measured glucose was in target range 70-180 mg/dL (time in range [TIR]) on days 3-14 of each arm, and key secondary outcomes included mean continuous glucose monitoring (CGM) glucose and the percent time sensor-measured glucose was in hypoglycemic range <54 mg/dL.
TIR was significantly higher in the BP arm than the UC arm (75 ± 11% vs. 62 ± 22%, P = 0.001). Mean CGM glucose was lower in the BP arm than in the UC arm (150 ± 19 vs. 171 ± 45 mg/dL, P = 0.007). There was no significant difference in percent time with sensor-measured glucose <54 mg/dL (0.27% vs. 0.36%, P = 1.0), although self-reported symptomatic hypoglycemia episodes were higher during the BP arm than the UC arm (0.7 vs. 0.4 median episodes per day, P = 0.01). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either arm.
Adults with CFRD had improved glucose control without an increase in CGM-measured hypoglycemia with the BP compared with their UC, suggesting that this may be an important therapeutic option for this patient population.</abstract><cop>United States</cop><pub>American Diabetes Association</pub><pmid>37874987</pmid><doi>10.2337/dc23-1411</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-7655-8954</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0149-5992 |
| ispartof | Diabetes care, 2024-01, Vol.47 (1), p.101-108 |
| issn | 0149-5992 1935-5548 1935-5548 |
| language | eng |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Adult Adults Bionics Blood Glucose Blood Glucose Self-Monitoring Cystic fibrosis Cystic Fibrosis - drug therapy Diabetes Diabetes mellitus Diabetes Mellitus, Type 1 - drug therapy Glucose Glucose monitoring Humans Hypoglycemia Hypoglycemia - drug therapy Hypoglycemic Agents - therapeutic use Insulin Insulin - therapeutic use Insulin Infusion Systems Insulin, Regular, Human - therapeutic use Ketoacidosis Morbidity Original Pancreas Sensors Time measurement |
| title | Randomized Trial of the Insulin-Only iLet Bionic Pancreas for the Treatment of Cystic Fibrosis- Related Diabetes |
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