Evaluation of a Clinical Tool to Test and Adjust the Programmed Overnight Basal Profiles for Insulin Pump Therapy: A Pilot Study
Abstract Objective Clinical protocols for basal rate testing and adjustment are needed for effective insulin pump therapy. We evaluated the effects of a continuous glucose monitoring (CGM)-based semiautomated basal algorithm on glycemia. Methods We developed and piloted a basal rate analyzer that in...
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| Veröffentlicht in: | Canadian journal of diabetes 2015-10, Vol.39 (5), p.364-372 |
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| creator | Orszag, Andrej, MD Falappa, C. Marcelo, MD Lovblom, Leif E., MSc Partridge, Helen, MRCP Tschirhart, Holly, BScN Boulet, Genevieve, MD Picton, Peter, MASc, PEng Cafazzo, Joseph A., PhD, PEng Perkins, Bruce A., MD, MPH, FRCP(C) |
| description | Abstract Objective Clinical protocols for basal rate testing and adjustment are needed for effective insulin pump therapy. We evaluated the effects of a continuous glucose monitoring (CGM)-based semiautomated basal algorithm on glycemia. Methods We developed and piloted a basal rate analyzer that interpreted CGM data from overnight fasts and recommended dose changes for subsequent nights. Subjects uploaded data online using sensor-augmented pumps for evaluation by the analyzer after each of 5 overnight fasts conducted over 2 to 8 weeks. It was designed to be conservative and iterative, making changes that did not exceed 10% at each iteration. The standard deviation and interquartile range of CGM values from midnight to 7 am (SD12-7am and IQR12-7am ) over 3 baseline and 3 postintervention nights, hypoglycemia incidence (CGM values |
| doi_str_mv | 10.1016/j.jcjd.2015.01.005 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1720453133</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S1499267115000398</els_id><sourcerecordid>1720453133</sourcerecordid><originalsourceid>FETCH-LOGICAL-c481t-c04e8b68bcb010a65626fc61bd04fefaabd7b24f0e5fb44ac9d80e713a26aafe3</originalsourceid><addsrcrecordid>eNp9kU-LFDEQxYMo7rj6BTxIjl66raT_iwizw6oLCzuw4zmkk8pO2u7OmHQPzM2PbpoZPXjwVAX13oP6PULeMkgZsPJDl3aq0ykHVqTAUoDiGVnxrOBJVufwnKxY3jQJLyt2RV6F0EUBVKx5Sa54UfMKimJFft0eZT_LybqROkMl3fR2tEr2dOdcTydHdxgmKkdN17qb4zrtkW69e_JyGFDThyP60T7tJ3ojQ7TFk7E9Bmqcp3djmGMe3c7Dge726OXh9JGu6db2bqKP06xPr8kLI_uAby7zmnz_crvbfEvuH77ebdb3icprNiUKcqzbsm5VCwxkWZS8NKpkrYbcoJGy1VXLcwNYmDbPpWp0DVixTPJSSoPZNXl_zj1493OOP4nBBoV9L0d0cxCs4pAXGcuyKOVnqfIuBI9GHLwdpD8JBmIhLzqxkBcLeQFMRLDR9O6SP7eRy1_LH9RR8OkswPjl0aIXQVkcFWrrUU1CO_v__M__2NWlqR94wtC52Y-Rn2AicAHicel-qZ4VAJA1dfYbFn2q0w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1720453133</pqid></control><display><type>article</type><title>Evaluation of a Clinical Tool to Test and Adjust the Programmed Overnight Basal Profiles for Insulin Pump Therapy: A Pilot Study</title><source>MEDLINE</source><source>Alma/SFX Local Collection</source><creator>Orszag, Andrej, MD ; Falappa, C. Marcelo, MD ; Lovblom, Leif E., MSc ; Partridge, Helen, MRCP ; Tschirhart, Holly, BScN ; Boulet, Genevieve, MD ; Picton, Peter, MASc, PEng ; Cafazzo, Joseph A., PhD, PEng ; Perkins, Bruce A., MD, MPH, FRCP(C)</creator><creatorcontrib>Orszag, Andrej, MD ; Falappa, C. Marcelo, MD ; Lovblom, Leif E., MSc ; Partridge, Helen, MRCP ; Tschirhart, Holly, BScN ; Boulet, Genevieve, MD ; Picton, Peter, MASc, PEng ; Cafazzo, Joseph A., PhD, PEng ; Perkins, Bruce A., MD, MPH, FRCP(C)</creatorcontrib><description>Abstract Objective Clinical protocols for basal rate testing and adjustment are needed for effective insulin pump therapy. We evaluated the effects of a continuous glucose monitoring (CGM)-based semiautomated basal algorithm on glycemia. Methods We developed and piloted a basal rate analyzer that interpreted CGM data from overnight fasts and recommended dose changes for subsequent nights. Subjects uploaded data online using sensor-augmented pumps for evaluation by the analyzer after each of 5 overnight fasts conducted over 2 to 8 weeks. It was designed to be conservative and iterative, making changes that did not exceed 10% at each iteration. The standard deviation and interquartile range of CGM values from midnight to 7 am (SD12-7am and IQR12-7am ) over 3 baseline and 3 postintervention nights, hypoglycemia incidence (CGM values <4.0 mmol/L), and glycated hemoglobin (A1C) were compared. Results Twenty subjects with mean ages of 38±13 years and A1C 7.6%±0.8% (60±8.7 mmol/mol) underwent the 5 iterations of basal assessments over 5±3 weeks. SD12-7am and IQR12-7am did not change from baseline to postintervention (1.57±0.8 to 1.63±0.8 mmol/L; p=0.35; 3.66±2.07 to 3.47±2.26 mmol/L; p=0.90). However, mean glucose values were lower between 2 to 3 am at baseline compared to postintervention; 3-night hypoglycemia incidence declined from 1.6±1.8 to 0.5±0.7 episodes (p=0.01), and A1C improved from 7.6%±0.8% to 7.4%±0.9% (60%±8.7% to 57%±9.8% mmol/mol; p=0.03). Conclusions The use of a basal rate analyzer was associated with reduced hypoglycemia and improved A1C. However, overnight glycemic stability was not improved. Further research into the efficacy of the CGM-based semiautomated algorithm is warranted.</description><identifier>ISSN: 1499-2671</identifier><identifier>EISSN: 2352-3840</identifier><identifier>DOI: 10.1016/j.jcjd.2015.01.005</identifier><identifier>PMID: 25827055</identifier><language>eng</language><publisher>Canada: Elsevier Inc</publisher><subject>Adult ; basal insulin assessment ; Blood Glucose ; continuous glucose monitoring ; continuous subcutaneous insulin infusion ; diabète de type 1 ; Endocrinology & Metabolism ; estimation de l’insuline basale ; Female ; Humans ; Insulin Infusion Systems ; insulin pump therapy ; Male ; Middle Aged ; Monitoring, Physiologic - instrumentation ; Monitoring, Physiologic - methods ; Other ; perfusion sous-cutanée continue d’insuline ; Pilot Projects ; surveillance de la glycémie en continu ; thérapie par pompe à insuline ; type 1 diabetes</subject><ispartof>Canadian journal of diabetes, 2015-10, Vol.39 (5), p.364-372</ispartof><rights>Canadian Diabetes Association</rights><rights>2015 Canadian Diabetes Association</rights><rights>Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c481t-c04e8b68bcb010a65626fc61bd04fefaabd7b24f0e5fb44ac9d80e713a26aafe3</citedby><cites>FETCH-LOGICAL-c481t-c04e8b68bcb010a65626fc61bd04fefaabd7b24f0e5fb44ac9d80e713a26aafe3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,781,785,27926,27927</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25827055$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Orszag, Andrej, MD</creatorcontrib><creatorcontrib>Falappa, C. Marcelo, MD</creatorcontrib><creatorcontrib>Lovblom, Leif E., MSc</creatorcontrib><creatorcontrib>Partridge, Helen, MRCP</creatorcontrib><creatorcontrib>Tschirhart, Holly, BScN</creatorcontrib><creatorcontrib>Boulet, Genevieve, MD</creatorcontrib><creatorcontrib>Picton, Peter, MASc, PEng</creatorcontrib><creatorcontrib>Cafazzo, Joseph A., PhD, PEng</creatorcontrib><creatorcontrib>Perkins, Bruce A., MD, MPH, FRCP(C)</creatorcontrib><title>Evaluation of a Clinical Tool to Test and Adjust the Programmed Overnight Basal Profiles for Insulin Pump Therapy: A Pilot Study</title><title>Canadian journal of diabetes</title><addtitle>Can J Diabetes</addtitle><description>Abstract Objective Clinical protocols for basal rate testing and adjustment are needed for effective insulin pump therapy. We evaluated the effects of a continuous glucose monitoring (CGM)-based semiautomated basal algorithm on glycemia. Methods We developed and piloted a basal rate analyzer that interpreted CGM data from overnight fasts and recommended dose changes for subsequent nights. Subjects uploaded data online using sensor-augmented pumps for evaluation by the analyzer after each of 5 overnight fasts conducted over 2 to 8 weeks. It was designed to be conservative and iterative, making changes that did not exceed 10% at each iteration. The standard deviation and interquartile range of CGM values from midnight to 7 am (SD12-7am and IQR12-7am ) over 3 baseline and 3 postintervention nights, hypoglycemia incidence (CGM values <4.0 mmol/L), and glycated hemoglobin (A1C) were compared. Results Twenty subjects with mean ages of 38±13 years and A1C 7.6%±0.8% (60±8.7 mmol/mol) underwent the 5 iterations of basal assessments over 5±3 weeks. SD12-7am and IQR12-7am did not change from baseline to postintervention (1.57±0.8 to 1.63±0.8 mmol/L; p=0.35; 3.66±2.07 to 3.47±2.26 mmol/L; p=0.90). However, mean glucose values were lower between 2 to 3 am at baseline compared to postintervention; 3-night hypoglycemia incidence declined from 1.6±1.8 to 0.5±0.7 episodes (p=0.01), and A1C improved from 7.6%±0.8% to 7.4%±0.9% (60%±8.7% to 57%±9.8% mmol/mol; p=0.03). Conclusions The use of a basal rate analyzer was associated with reduced hypoglycemia and improved A1C. However, overnight glycemic stability was not improved. Further research into the efficacy of the CGM-based semiautomated algorithm is warranted.</description><subject>Adult</subject><subject>basal insulin assessment</subject><subject>Blood Glucose</subject><subject>continuous glucose monitoring</subject><subject>continuous subcutaneous insulin infusion</subject><subject>diabète de type 1</subject><subject>Endocrinology & Metabolism</subject><subject>estimation de l’insuline basale</subject><subject>Female</subject><subject>Humans</subject><subject>Insulin Infusion Systems</subject><subject>insulin pump therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Monitoring, Physiologic - instrumentation</subject><subject>Monitoring, Physiologic - methods</subject><subject>Other</subject><subject>perfusion sous-cutanée continue d’insuline</subject><subject>Pilot Projects</subject><subject>surveillance de la glycémie en continu</subject><subject>thérapie par pompe à insuline</subject><subject>type 1 diabetes</subject><issn>1499-2671</issn><issn>2352-3840</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU-LFDEQxYMo7rj6BTxIjl66raT_iwizw6oLCzuw4zmkk8pO2u7OmHQPzM2PbpoZPXjwVAX13oP6PULeMkgZsPJDl3aq0ykHVqTAUoDiGVnxrOBJVufwnKxY3jQJLyt2RV6F0EUBVKx5Sa54UfMKimJFft0eZT_LybqROkMl3fR2tEr2dOdcTydHdxgmKkdN17qb4zrtkW69e_JyGFDThyP60T7tJ3ojQ7TFk7E9Bmqcp3djmGMe3c7Dge726OXh9JGu6db2bqKP06xPr8kLI_uAby7zmnz_crvbfEvuH77ebdb3icprNiUKcqzbsm5VCwxkWZS8NKpkrYbcoJGy1VXLcwNYmDbPpWp0DVixTPJSSoPZNXl_zj1493OOP4nBBoV9L0d0cxCs4pAXGcuyKOVnqfIuBI9GHLwdpD8JBmIhLzqxkBcLeQFMRLDR9O6SP7eRy1_LH9RR8OkswPjl0aIXQVkcFWrrUU1CO_v__M__2NWlqR94wtC52Y-Rn2AicAHicel-qZ4VAJA1dfYbFn2q0w</recordid><startdate>20151001</startdate><enddate>20151001</enddate><creator>Orszag, Andrej, MD</creator><creator>Falappa, C. Marcelo, MD</creator><creator>Lovblom, Leif E., MSc</creator><creator>Partridge, Helen, MRCP</creator><creator>Tschirhart, Holly, BScN</creator><creator>Boulet, Genevieve, MD</creator><creator>Picton, Peter, MASc, PEng</creator><creator>Cafazzo, Joseph A., PhD, PEng</creator><creator>Perkins, Bruce A., MD, MPH, FRCP(C)</creator><general>Elsevier Inc</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>7X8</scope></search><sort><creationdate>20151001</creationdate><title>Evaluation of a Clinical Tool to Test and Adjust the Programmed Overnight Basal Profiles for Insulin Pump Therapy: A Pilot Study</title><author>Orszag, Andrej, MD ; Falappa, C. Marcelo, MD ; Lovblom, Leif E., MSc ; Partridge, Helen, MRCP ; Tschirhart, Holly, BScN ; Boulet, Genevieve, MD ; Picton, Peter, MASc, PEng ; Cafazzo, Joseph A., PhD, PEng ; Perkins, Bruce A., MD, MPH, FRCP(C)</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c481t-c04e8b68bcb010a65626fc61bd04fefaabd7b24f0e5fb44ac9d80e713a26aafe3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>basal insulin assessment</topic><topic>Blood Glucose</topic><topic>continuous glucose monitoring</topic><topic>continuous subcutaneous insulin infusion</topic><topic>diabète de type 1</topic><topic>Endocrinology & Metabolism</topic><topic>estimation de l’insuline basale</topic><topic>Female</topic><topic>Humans</topic><topic>Insulin Infusion Systems</topic><topic>insulin pump therapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Monitoring, Physiologic - instrumentation</topic><topic>Monitoring, Physiologic - methods</topic><topic>Other</topic><topic>perfusion sous-cutanée continue d’insuline</topic><topic>Pilot Projects</topic><topic>surveillance de la glycémie en continu</topic><topic>thérapie par pompe à insuline</topic><topic>type 1 diabetes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Orszag, Andrej, MD</creatorcontrib><creatorcontrib>Falappa, C. Marcelo, MD</creatorcontrib><creatorcontrib>Lovblom, Leif E., MSc</creatorcontrib><creatorcontrib>Partridge, Helen, MRCP</creatorcontrib><creatorcontrib>Tschirhart, Holly, BScN</creatorcontrib><creatorcontrib>Boulet, Genevieve, MD</creatorcontrib><creatorcontrib>Picton, Peter, MASc, PEng</creatorcontrib><creatorcontrib>Cafazzo, Joseph A., PhD, PEng</creatorcontrib><creatorcontrib>Perkins, Bruce A., MD, MPH, FRCP(C)</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Canadian journal of diabetes</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Orszag, Andrej, MD</au><au>Falappa, C. Marcelo, MD</au><au>Lovblom, Leif E., MSc</au><au>Partridge, Helen, MRCP</au><au>Tschirhart, Holly, BScN</au><au>Boulet, Genevieve, MD</au><au>Picton, Peter, MASc, PEng</au><au>Cafazzo, Joseph A., PhD, PEng</au><au>Perkins, Bruce A., MD, MPH, FRCP(C)</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of a Clinical Tool to Test and Adjust the Programmed Overnight Basal Profiles for Insulin Pump Therapy: A Pilot Study</atitle><jtitle>Canadian journal of diabetes</jtitle><addtitle>Can J Diabetes</addtitle><date>2015-10-01</date><risdate>2015</risdate><volume>39</volume><issue>5</issue><spage>364</spage><epage>372</epage><pages>364-372</pages><issn>1499-2671</issn><eissn>2352-3840</eissn><abstract>Abstract Objective Clinical protocols for basal rate testing and adjustment are needed for effective insulin pump therapy. We evaluated the effects of a continuous glucose monitoring (CGM)-based semiautomated basal algorithm on glycemia. Methods We developed and piloted a basal rate analyzer that interpreted CGM data from overnight fasts and recommended dose changes for subsequent nights. Subjects uploaded data online using sensor-augmented pumps for evaluation by the analyzer after each of 5 overnight fasts conducted over 2 to 8 weeks. It was designed to be conservative and iterative, making changes that did not exceed 10% at each iteration. The standard deviation and interquartile range of CGM values from midnight to 7 am (SD12-7am and IQR12-7am ) over 3 baseline and 3 postintervention nights, hypoglycemia incidence (CGM values <4.0 mmol/L), and glycated hemoglobin (A1C) were compared. Results Twenty subjects with mean ages of 38±13 years and A1C 7.6%±0.8% (60±8.7 mmol/mol) underwent the 5 iterations of basal assessments over 5±3 weeks. SD12-7am and IQR12-7am did not change from baseline to postintervention (1.57±0.8 to 1.63±0.8 mmol/L; p=0.35; 3.66±2.07 to 3.47±2.26 mmol/L; p=0.90). However, mean glucose values were lower between 2 to 3 am at baseline compared to postintervention; 3-night hypoglycemia incidence declined from 1.6±1.8 to 0.5±0.7 episodes (p=0.01), and A1C improved from 7.6%±0.8% to 7.4%±0.9% (60%±8.7% to 57%±9.8% mmol/mol; p=0.03). Conclusions The use of a basal rate analyzer was associated with reduced hypoglycemia and improved A1C. However, overnight glycemic stability was not improved. Further research into the efficacy of the CGM-based semiautomated algorithm is warranted.</abstract><cop>Canada</cop><pub>Elsevier Inc</pub><pmid>25827055</pmid><doi>10.1016/j.jcjd.2015.01.005</doi><tpages>9</tpages></addata></record> |
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| subjects | Adult basal insulin assessment Blood Glucose continuous glucose monitoring continuous subcutaneous insulin infusion diabète de type 1 Endocrinology & Metabolism estimation de l’insuline basale Female Humans Insulin Infusion Systems insulin pump therapy Male Middle Aged Monitoring, Physiologic - instrumentation Monitoring, Physiologic - methods Other perfusion sous-cutanée continue d’insuline Pilot Projects surveillance de la glycémie en continu thérapie par pompe à insuline type 1 diabetes |
| title | Evaluation of a Clinical Tool to Test and Adjust the Programmed Overnight Basal Profiles for Insulin Pump Therapy: A Pilot Study |
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