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Effectiveness of V-Go® for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study
Background V-Go is a wearable, patch-like, 24-h insulin delivery device that delivers both a continuous preset basal rate and on-demand bolus dosing. The aim of this study was to observe glycemic control, insulin dosing, and hypoglycemia risk in patients switched to V-Go in a real-world setting. The...
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| Published in: | Drugs - real world outcomes 2020-03, Vol.7 (1), p.31-40 |
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| container_title | Drugs - real world outcomes |
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| creator | Grunberger, George Rosenfeld, Cheryl R. Bode, Bruce W. Abbott, Scott D. Nikkel, Carla Shi, Leon Strange, Poul |
| description | Background
V-Go is a wearable, patch-like, 24-h insulin delivery device that delivers both a continuous preset basal rate and on-demand bolus dosing. The aim of this study was to observe glycemic control, insulin dosing, and hypoglycemia risk in patients switched to V-Go in a real-world setting. The primary objective was to compare change in mean hemoglobin A1c (HbA1c) from baseline to the end of V-Go use.
Methods
This prospective, open-label, multicenter study recruited patients with type 2 diabetes (T2D) and suboptimal glycemic control (HbA1c ≥ 7%) across 28 centers. Efficacy analyses were conducted for all patients with a post-baseline HbA1c and results stratified based on prior antihyperglycemic medication therapies. Insulin dosing was at the discretion of the health care provider and the protocol did not mandate glycemic targets. Treatment satisfaction surveys were utilized to gain patient feedback on the use of V-Go.
Results
One hundred eighty-eight patients were enrolled in the study, among whom 140 patients had a valid post-baseline HbA1c and were included in the primary efficacy analysis. Use of V-Go resulted in a change of − 0.64%; (
P
= 0.003) in HbA1c from baseline, and in those prescribed insulin, the total daily dose of insulin was decreased by 12 units/day (
P
|
| doi_str_mv | 10.1007/s40801-019-00173-8 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_doaj_</sourceid><recordid>TN_cdi_doaj_primary_oai_doaj_org_article_28f840a6feea4b70b5b2d5296aef74f3</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><doaj_id>oai_doaj_org_article_28f840a6feea4b70b5b2d5296aef74f3</doaj_id><sourcerecordid>2336999201</sourcerecordid><originalsourceid>FETCH-LOGICAL-c540t-d456e1f466a5e8f4b02a6c14c4a4c3434c561e6a3b7a276740caceb2ec7055f3</originalsourceid><addsrcrecordid>eNp9ks1u1DAURiMEolXpC7BAltiwSfFfbIcFUlVKqVSpFR3B0nKc66mrTDzYzqB5KR6iT4aZlEJZsLLle3zse_VV1UuCjwjG8m3iWGFSY9LWGBPJavWk2qekVXUrlXq627c1IQ3fqw5T8h3mXDKuuHxe7TGiGMME71f51Dmw2W9ghJRQcOhLfRbufiAXIroy2cOYE_ru8w1abNeAKPrgTQcZEvIjMugzmKH-GuLQo2vI2Y_Ld-gYXcWQ1rMWXXYJ4qaYwmgGdJ2nfvuieubMkODwfj2oFh9PFyef6ovLs_OT44vaNhznuueNAOK4EKYB5XiHqRGWcMsNt4wzbhtBQBjWSUOlkBxbY6GjYCVuGscOqvNZ2wdzq9fRr0zc6mC83h2EuNQmZm8H0FQ5xbERDsDwTuKu6Wjf0FYYcJI7VlzvZ9d66lbQ2zKWaIZH0seV0d_oZdhoiQVuJS2CN_eCGL5NkLJe-WRhGMwIYUqaMibatqWYFPT1P-htmGKZXqFEaY0wSZtC0ZmyZdgpgnv4DMH6V0T0HBFdIqJ3EdGqXHr1dxsPV34HogBsBlIpjUuIf97-j_Yn5wXHyA</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2670513725</pqid></control><display><type>article</type><title>Effectiveness of V-Go® for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study</title><source>ABI/INFORM Collection</source><source>Springer Nature - SpringerLink Journals - Fully Open Access</source><source>Publicly Available Content (ProQuest)</source><source>PubMed Central</source><source>Alma/SFX Local Collection</source><creator>Grunberger, George ; Rosenfeld, Cheryl R. ; Bode, Bruce W. ; Abbott, Scott D. ; Nikkel, Carla ; Shi, Leon ; Strange, Poul</creator><creatorcontrib>Grunberger, George ; Rosenfeld, Cheryl R. ; Bode, Bruce W. ; Abbott, Scott D. ; Nikkel, Carla ; Shi, Leon ; Strange, Poul</creatorcontrib><description>Background
V-Go is a wearable, patch-like, 24-h insulin delivery device that delivers both a continuous preset basal rate and on-demand bolus dosing. The aim of this study was to observe glycemic control, insulin dosing, and hypoglycemia risk in patients switched to V-Go in a real-world setting. The primary objective was to compare change in mean hemoglobin A1c (HbA1c) from baseline to the end of V-Go use.
Methods
This prospective, open-label, multicenter study recruited patients with type 2 diabetes (T2D) and suboptimal glycemic control (HbA1c ≥ 7%) across 28 centers. Efficacy analyses were conducted for all patients with a post-baseline HbA1c and results stratified based on prior antihyperglycemic medication therapies. Insulin dosing was at the discretion of the health care provider and the protocol did not mandate glycemic targets. Treatment satisfaction surveys were utilized to gain patient feedback on the use of V-Go.
Results
One hundred eighty-eight patients were enrolled in the study, among whom 140 patients had a valid post-baseline HbA1c and were included in the primary efficacy analysis. Use of V-Go resulted in a change of − 0.64%; (
P
= 0.003) in HbA1c from baseline, and in those prescribed insulin, the total daily dose of insulin was decreased by 12 units/day (
P
< 0.0001). Twenty-two patients (12%) reported hypoglycemic events (≤ 70 mg/dL), with an event rate of 1.51 events/patient/year.
Conclusion
In a T2D population with suboptimal HbA1c, initiating V-Go therapy in a real-world setting significantly improved glycemic control and led to significant insulin dose reductions.
ClinicalTrial.gov registry identifier: NCT01326598.</description><identifier>ISSN: 2199-1154</identifier><identifier>EISSN: 2198-9788</identifier><identifier>DOI: 10.1007/s40801-019-00173-8</identifier><identifier>PMID: 31833010</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Clinical outcomes ; Creatinine ; Diabetes ; Drug dosages ; Effectiveness ; Glucose ; Hypoglycemia ; Insulin ; Internal Medicine ; Medicine ; Medicine & Public Health ; NCT ; NCT01326598 ; Observational studies ; Original ; Original Research Article ; Patient satisfaction ; Patients ; Pharmacology/Toxicology ; Pharmacotherapy ; Substance abuse treatment</subject><ispartof>Drugs - real world outcomes, 2020-03, Vol.7 (1), p.31-40</ispartof><rights>The Author(s) 2019</rights><rights>The Author(s) 2019. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c540t-d456e1f466a5e8f4b02a6c14c4a4c3434c561e6a3b7a276740caceb2ec7055f3</citedby><cites>FETCH-LOGICAL-c540t-d456e1f466a5e8f4b02a6c14c4a4c3434c561e6a3b7a276740caceb2ec7055f3</cites><orcidid>0000-0002-7206-1094</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2670513725/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2670513725?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,11687,25752,27923,27924,36059,37011,44362,44589,53790,53792,74666,74897</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31833010$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Grunberger, George</creatorcontrib><creatorcontrib>Rosenfeld, Cheryl R.</creatorcontrib><creatorcontrib>Bode, Bruce W.</creatorcontrib><creatorcontrib>Abbott, Scott D.</creatorcontrib><creatorcontrib>Nikkel, Carla</creatorcontrib><creatorcontrib>Shi, Leon</creatorcontrib><creatorcontrib>Strange, Poul</creatorcontrib><title>Effectiveness of V-Go® for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study</title><title>Drugs - real world outcomes</title><addtitle>Drugs - Real World Outcomes</addtitle><addtitle>Drugs Real World Outcomes</addtitle><description>Background
V-Go is a wearable, patch-like, 24-h insulin delivery device that delivers both a continuous preset basal rate and on-demand bolus dosing. The aim of this study was to observe glycemic control, insulin dosing, and hypoglycemia risk in patients switched to V-Go in a real-world setting. The primary objective was to compare change in mean hemoglobin A1c (HbA1c) from baseline to the end of V-Go use.
Methods
This prospective, open-label, multicenter study recruited patients with type 2 diabetes (T2D) and suboptimal glycemic control (HbA1c ≥ 7%) across 28 centers. Efficacy analyses were conducted for all patients with a post-baseline HbA1c and results stratified based on prior antihyperglycemic medication therapies. Insulin dosing was at the discretion of the health care provider and the protocol did not mandate glycemic targets. Treatment satisfaction surveys were utilized to gain patient feedback on the use of V-Go.
Results
One hundred eighty-eight patients were enrolled in the study, among whom 140 patients had a valid post-baseline HbA1c and were included in the primary efficacy analysis. Use of V-Go resulted in a change of − 0.64%; (
P
= 0.003) in HbA1c from baseline, and in those prescribed insulin, the total daily dose of insulin was decreased by 12 units/day (
P
< 0.0001). Twenty-two patients (12%) reported hypoglycemic events (≤ 70 mg/dL), with an event rate of 1.51 events/patient/year.
Conclusion
In a T2D population with suboptimal HbA1c, initiating V-Go therapy in a real-world setting significantly improved glycemic control and led to significant insulin dose reductions.
ClinicalTrial.gov registry identifier: NCT01326598.</description><subject>Clinical outcomes</subject><subject>Creatinine</subject><subject>Diabetes</subject><subject>Drug dosages</subject><subject>Effectiveness</subject><subject>Glucose</subject><subject>Hypoglycemia</subject><subject>Insulin</subject><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>NCT</subject><subject>NCT01326598</subject><subject>Observational studies</subject><subject>Original</subject><subject>Original Research Article</subject><subject>Patient satisfaction</subject><subject>Patients</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacotherapy</subject><subject>Substance abuse treatment</subject><issn>2199-1154</issn><issn>2198-9788</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>M0C</sourceid><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNp9ks1u1DAURiMEolXpC7BAltiwSfFfbIcFUlVKqVSpFR3B0nKc66mrTDzYzqB5KR6iT4aZlEJZsLLle3zse_VV1UuCjwjG8m3iWGFSY9LWGBPJavWk2qekVXUrlXq627c1IQ3fqw5T8h3mXDKuuHxe7TGiGMME71f51Dmw2W9ghJRQcOhLfRbufiAXIroy2cOYE_ru8w1abNeAKPrgTQcZEvIjMugzmKH-GuLQo2vI2Y_Ld-gYXcWQ1rMWXXYJ4qaYwmgGdJ2nfvuieubMkODwfj2oFh9PFyef6ovLs_OT44vaNhznuueNAOK4EKYB5XiHqRGWcMsNt4wzbhtBQBjWSUOlkBxbY6GjYCVuGscOqvNZ2wdzq9fRr0zc6mC83h2EuNQmZm8H0FQ5xbERDsDwTuKu6Wjf0FYYcJI7VlzvZ9d66lbQ2zKWaIZH0seV0d_oZdhoiQVuJS2CN_eCGL5NkLJe-WRhGMwIYUqaMibatqWYFPT1P-htmGKZXqFEaY0wSZtC0ZmyZdgpgnv4DMH6V0T0HBFdIqJ3EdGqXHr1dxsPV34HogBsBlIpjUuIf97-j_Yn5wXHyA</recordid><startdate>20200301</startdate><enddate>20200301</enddate><creator>Grunberger, George</creator><creator>Rosenfeld, Cheryl R.</creator><creator>Bode, Bruce W.</creator><creator>Abbott, Scott D.</creator><creator>Nikkel, Carla</creator><creator>Shi, Leon</creator><creator>Strange, Poul</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><general>Adis, Springer Healthcare</general><scope>C6C</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7WY</scope><scope>7WZ</scope><scope>7X7</scope><scope>7XB</scope><scope>87Z</scope><scope>88C</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8FL</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BEZIV</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FRNLG</scope><scope>FYUFA</scope><scope>F~G</scope><scope>GHDGH</scope><scope>K60</scope><scope>K6~</scope><scope>K9.</scope><scope>KB0</scope><scope>L.-</scope><scope>M0C</scope><scope>M0S</scope><scope>M0T</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQBIZ</scope><scope>PQBZA</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-7206-1094</orcidid></search><sort><creationdate>20200301</creationdate><title>Effectiveness of V-Go® for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study</title><author>Grunberger, George ; Rosenfeld, Cheryl R. ; Bode, Bruce W. ; Abbott, Scott D. ; Nikkel, Carla ; Shi, Leon ; Strange, Poul</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c540t-d456e1f466a5e8f4b02a6c14c4a4c3434c561e6a3b7a276740caceb2ec7055f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Clinical outcomes</topic><topic>Creatinine</topic><topic>Diabetes</topic><topic>Drug dosages</topic><topic>Effectiveness</topic><topic>Glucose</topic><topic>Hypoglycemia</topic><topic>Insulin</topic><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>NCT</topic><topic>NCT01326598</topic><topic>Observational studies</topic><topic>Original</topic><topic>Original Research Article</topic><topic>Patient satisfaction</topic><topic>Patients</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacotherapy</topic><topic>Substance abuse treatment</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Grunberger, George</creatorcontrib><creatorcontrib>Rosenfeld, Cheryl R.</creatorcontrib><creatorcontrib>Bode, Bruce W.</creatorcontrib><creatorcontrib>Abbott, Scott D.</creatorcontrib><creatorcontrib>Nikkel, Carla</creatorcontrib><creatorcontrib>Shi, Leon</creatorcontrib><creatorcontrib>Strange, Poul</creatorcontrib><collection>SpringerOpen</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>ABI/INFORM Collection</collection><collection>ABI/INFORM Global (PDF only)</collection><collection>ProQuest Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ABI/INFORM Collection</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>ProQuest Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ABI/INFORM Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>Business Premium Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Business Premium Collection (Alumni)</collection><collection>Health Research Premium Collection</collection><collection>ABI/INFORM Global (Corporate)</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Business Collection (Alumni Edition)</collection><collection>ProQuest Business Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ABI/INFORM Professional Advanced</collection><collection>ABI/INFORM Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>ProQuest Healthcare Administration Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content (ProQuest)</collection><collection>One Business (ProQuest)</collection><collection>ProQuest One Business (Alumni)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Drugs - real world outcomes</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Grunberger, George</au><au>Rosenfeld, Cheryl R.</au><au>Bode, Bruce W.</au><au>Abbott, Scott D.</au><au>Nikkel, Carla</au><au>Shi, Leon</au><au>Strange, Poul</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness of V-Go® for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study</atitle><jtitle>Drugs - real world outcomes</jtitle><stitle>Drugs - Real World Outcomes</stitle><addtitle>Drugs Real World Outcomes</addtitle><date>2020-03-01</date><risdate>2020</risdate><volume>7</volume><issue>1</issue><spage>31</spage><epage>40</epage><pages>31-40</pages><issn>2199-1154</issn><eissn>2198-9788</eissn><abstract>Background
V-Go is a wearable, patch-like, 24-h insulin delivery device that delivers both a continuous preset basal rate and on-demand bolus dosing. The aim of this study was to observe glycemic control, insulin dosing, and hypoglycemia risk in patients switched to V-Go in a real-world setting. The primary objective was to compare change in mean hemoglobin A1c (HbA1c) from baseline to the end of V-Go use.
Methods
This prospective, open-label, multicenter study recruited patients with type 2 diabetes (T2D) and suboptimal glycemic control (HbA1c ≥ 7%) across 28 centers. Efficacy analyses were conducted for all patients with a post-baseline HbA1c and results stratified based on prior antihyperglycemic medication therapies. Insulin dosing was at the discretion of the health care provider and the protocol did not mandate glycemic targets. Treatment satisfaction surveys were utilized to gain patient feedback on the use of V-Go.
Results
One hundred eighty-eight patients were enrolled in the study, among whom 140 patients had a valid post-baseline HbA1c and were included in the primary efficacy analysis. Use of V-Go resulted in a change of − 0.64%; (
P
= 0.003) in HbA1c from baseline, and in those prescribed insulin, the total daily dose of insulin was decreased by 12 units/day (
P
< 0.0001). Twenty-two patients (12%) reported hypoglycemic events (≤ 70 mg/dL), with an event rate of 1.51 events/patient/year.
Conclusion
In a T2D population with suboptimal HbA1c, initiating V-Go therapy in a real-world setting significantly improved glycemic control and led to significant insulin dose reductions.
ClinicalTrial.gov registry identifier: NCT01326598.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>31833010</pmid><doi>10.1007/s40801-019-00173-8</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-7206-1094</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 2199-1154 |
| ispartof | Drugs - real world outcomes, 2020-03, Vol.7 (1), p.31-40 |
| issn | 2199-1154 2198-9788 |
| language | eng |
| recordid | cdi_doaj_primary_oai_doaj_org_article_28f840a6feea4b70b5b2d5296aef74f3 |
| source | ABI/INFORM Collection; Springer Nature - SpringerLink Journals - Fully Open Access; Publicly Available Content (ProQuest); PubMed Central; Alma/SFX Local Collection |
| subjects | Clinical outcomes Creatinine Diabetes Drug dosages Effectiveness Glucose Hypoglycemia Insulin Internal Medicine Medicine Medicine & Public Health NCT NCT01326598 Observational studies Original Original Research Article Patient satisfaction Patients Pharmacology/Toxicology Pharmacotherapy Substance abuse treatment |
| title | Effectiveness of V-Go® for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study |
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