Does fully closed‐loop automated insulin delivery improve glycaemic control in patients with type 2 diabetes? A meta‐analysis of randomized controlled trials
Aims This meta‐analysis investigated the efficacy and safety of fully closed‐loop automated insulin delivery (AID) in patients with type 2 diabetes. Materials and Methods We systemically searched PubMed, Scopus, Web of Science, and Cochrane Central from inception until April 26, 2023. We included ra...
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| Veröffentlicht in: | Diabetic medicine 2024-01, Vol.41 (1), p.e15196-n/a |
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| creator | Amer, Basma Ehab Yaqout, Yasmeen Essam Abozaid, Ahmed Mohamed Afifi, Eslam Aboelkhier, Menna M. |
| description | Aims
This meta‐analysis investigated the efficacy and safety of fully closed‐loop automated insulin delivery (AID) in patients with type 2 diabetes.
Materials and Methods
We systemically searched PubMed, Scopus, Web of Science, and Cochrane Central from inception until April 26, 2023. We included randomized controlled trials (RCTs) comparing fully closed‐loop AID versus conventional insulin therapy. The outcomes were pooled as the mean difference (MD) and risk ratio with 95% confidence interval (CI) in the random effect model. Our primary outcome was the proportion of time in the target glucose range (5.6‐10 mmol/L, 3.9‐10 mmol/L, or 3.9‐8 mmol/L, depending on the study). Key secondary outcomes included the proportion of time spent in hyperglycaemia or hypoglycaemia.
Results
We included seven RCTs (three crossover and four parallel design), compromising 390 patients. Our analysis showed that compared to the control group, fully closed‐loop AID increased the proportion of time spent within the target glucose range by additional 337 min per 24 h (MD = 23.39%, 95% CI [16.64%, 30.14%], p |
| doi_str_mv | 10.1111/dme.15196 |
| format | Article |
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This meta‐analysis investigated the efficacy and safety of fully closed‐loop automated insulin delivery (AID) in patients with type 2 diabetes.
Materials and Methods
We systemically searched PubMed, Scopus, Web of Science, and Cochrane Central from inception until April 26, 2023. We included randomized controlled trials (RCTs) comparing fully closed‐loop AID versus conventional insulin therapy. The outcomes were pooled as the mean difference (MD) and risk ratio with 95% confidence interval (CI) in the random effect model. Our primary outcome was the proportion of time in the target glucose range (5.6‐10 mmol/L, 3.9‐10 mmol/L, or 3.9‐8 mmol/L, depending on the study). Key secondary outcomes included the proportion of time spent in hyperglycaemia or hypoglycaemia.
Results
We included seven RCTs (three crossover and four parallel design), compromising 390 patients. Our analysis showed that compared to the control group, fully closed‐loop AID increased the proportion of time spent within the target glucose range by additional 337 min per 24 h (MD = 23.39%, 95% CI [16.64%, 30.14%], p < 0.01), additional 108 min overnight (MD = 22.40%, 95% CI [12.88%, 31.91%], p < 0.01), and additional 258 min during the daytime period (MD = 26.85%, 95% CI [21.06%, 32.63%], p < 0.01). Compared to the control group, the overall time in hyperglycaemia was shortened by 326 min per 24 h (MD = −22.67%, 95% CI [−30.87%, −14.46%], p < 0.01). There was no significant difference between the two groups in terms of overall, overnight, and daytime periods spent in hypoglycaemia.
Conclusions
Our meta‐analysis suggests that fully closed‐loop AID may improve glycaemic control in patients with type 2 diabetes, particularly for those with more challenging diabetes management. Further research is required to establish the feasibility of implementing these systems in clinical practice. [Correction added on 26 August 2023 after first online publication: Under Results, the first sentence “We included seven RCTs (three crossover and one parallel designs)” has been changed to “We included seven RCTs (three crossover and four parallel designs)”.]</description><identifier>ISSN: 0742-3071</identifier><identifier>EISSN: 1464-5491</identifier><identifier>DOI: 10.1111/dme.15196</identifier><identifier>PMID: 37567739</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>AID ; Automation ; Blood Glucose ; Clinical trials ; Cross-Over Studies ; Daytime ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; Diabetes Mellitus, Type 1 - drug therapy ; Diabetes Mellitus, Type 2 - drug therapy ; Glucose ; Glycemic Control ; Humans ; hyperglycaemia ; Hyperglycemia ; Hyperglycemia - drug therapy ; Hyperglycemia - prevention & control ; hypoglycaemia ; Hypoglycemia ; Hypoglycemia - chemically induced ; Hypoglycemia - drug therapy ; Hypoglycemia - prevention & control ; Hypoglycemic Agents - therapeutic use ; Insulin ; Insulin - therapeutic use ; Insulin Infusion Systems ; Meta-analysis ; Randomized Controlled Trials as Topic ; time in target ; type 2 diabetes</subject><ispartof>Diabetic medicine, 2024-01, Vol.41 (1), p.e15196-n/a</ispartof><rights>2023 Diabetes UK.</rights><rights>Diabetic Medicine © 2024 Diabetes UK</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3536-ebc3df04dfe118ff0ab8a87fe5a145bbb50d5ac567c6143a0adbe4a221d44a4f3</citedby><cites>FETCH-LOGICAL-c3536-ebc3df04dfe118ff0ab8a87fe5a145bbb50d5ac567c6143a0adbe4a221d44a4f3</cites><orcidid>0000-0001-7787-5508</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fdme.15196$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdme.15196$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37567739$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Amer, Basma Ehab</creatorcontrib><creatorcontrib>Yaqout, Yasmeen Essam</creatorcontrib><creatorcontrib>Abozaid, Ahmed Mohamed</creatorcontrib><creatorcontrib>Afifi, Eslam</creatorcontrib><creatorcontrib>Aboelkhier, Menna M.</creatorcontrib><title>Does fully closed‐loop automated insulin delivery improve glycaemic control in patients with type 2 diabetes? A meta‐analysis of randomized controlled trials</title><title>Diabetic medicine</title><addtitle>Diabet Med</addtitle><description>Aims
This meta‐analysis investigated the efficacy and safety of fully closed‐loop automated insulin delivery (AID) in patients with type 2 diabetes.
Materials and Methods
We systemically searched PubMed, Scopus, Web of Science, and Cochrane Central from inception until April 26, 2023. We included randomized controlled trials (RCTs) comparing fully closed‐loop AID versus conventional insulin therapy. The outcomes were pooled as the mean difference (MD) and risk ratio with 95% confidence interval (CI) in the random effect model. Our primary outcome was the proportion of time in the target glucose range (5.6‐10 mmol/L, 3.9‐10 mmol/L, or 3.9‐8 mmol/L, depending on the study). Key secondary outcomes included the proportion of time spent in hyperglycaemia or hypoglycaemia.
Results
We included seven RCTs (three crossover and four parallel design), compromising 390 patients. Our analysis showed that compared to the control group, fully closed‐loop AID increased the proportion of time spent within the target glucose range by additional 337 min per 24 h (MD = 23.39%, 95% CI [16.64%, 30.14%], p < 0.01), additional 108 min overnight (MD = 22.40%, 95% CI [12.88%, 31.91%], p < 0.01), and additional 258 min during the daytime period (MD = 26.85%, 95% CI [21.06%, 32.63%], p < 0.01). Compared to the control group, the overall time in hyperglycaemia was shortened by 326 min per 24 h (MD = −22.67%, 95% CI [−30.87%, −14.46%], p < 0.01). There was no significant difference between the two groups in terms of overall, overnight, and daytime periods spent in hypoglycaemia.
Conclusions
Our meta‐analysis suggests that fully closed‐loop AID may improve glycaemic control in patients with type 2 diabetes, particularly for those with more challenging diabetes management. Further research is required to establish the feasibility of implementing these systems in clinical practice. [Correction added on 26 August 2023 after first online publication: Under Results, the first sentence “We included seven RCTs (three crossover and one parallel designs)” has been changed to “We included seven RCTs (three crossover and four parallel designs)”.]</description><subject>AID</subject><subject>Automation</subject><subject>Blood Glucose</subject><subject>Clinical trials</subject><subject>Cross-Over Studies</subject><subject>Daytime</subject><subject>Diabetes</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Diabetes Mellitus, Type 1 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Glucose</subject><subject>Glycemic Control</subject><subject>Humans</subject><subject>hyperglycaemia</subject><subject>Hyperglycemia</subject><subject>Hyperglycemia - drug therapy</subject><subject>Hyperglycemia - prevention & control</subject><subject>hypoglycaemia</subject><subject>Hypoglycemia</subject><subject>Hypoglycemia - chemically induced</subject><subject>Hypoglycemia - drug therapy</subject><subject>Hypoglycemia - prevention & control</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Insulin</subject><subject>Insulin - therapeutic use</subject><subject>Insulin Infusion Systems</subject><subject>Meta-analysis</subject><subject>Randomized Controlled Trials as Topic</subject><subject>time in target</subject><subject>type 2 diabetes</subject><issn>0742-3071</issn><issn>1464-5491</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc1u1TAQRi0EopfCghdAltjQRVo7tpObFara8iO1YgPraGKPwZUTB9tpFVY8Ql-BV-NJMNwLC6TOZmZxdEafPkKec3bMy5yYEY-54l3zgGy4bGSlZMcfkg1rZV0J1vID8iSla8Z43YnuMTkQrWraVnQb8uM8YKJ28X6l2oeE5uf3Ox_CTGHJYYSMhropLd5N1KB3NxhX6sY5hhukn_2qAUenqQ5TjsEXlM6QHU450VuXv9C8zkhrahwMmDG9pqd0xAzlCUzg1-QSDZZGmEwY3bfybG_y5czRgU9PySNbFj7b70Py6c3Fx7N31eWHt-_PTi8rLZRoKhy0MJZJY5HzrbUMhi1sW4sKuFTDMChmFOiSWzdcCmBgBpRQ19xICdKKQ_Jq5y3Zvi6Ycj-6pNF7mDAsqa-3igmmmoYV9OV_6HVYYslTqI5xoRrWiUId7SgdQ0oRbT9HN0Jce8763731pbf-T2-FfbE3LsOI5h_5t6gCnOyAW-dxvd_Un19d7JS_AHikp-Q</recordid><startdate>202401</startdate><enddate>202401</enddate><creator>Amer, Basma Ehab</creator><creator>Yaqout, Yasmeen Essam</creator><creator>Abozaid, Ahmed Mohamed</creator><creator>Afifi, Eslam</creator><creator>Aboelkhier, Menna M.</creator><general>Wiley Subscription Services, 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>7T5</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-7787-5508</orcidid></search><sort><creationdate>202401</creationdate><title>Does fully closed‐loop automated insulin delivery improve glycaemic control in patients with type 2 diabetes? A meta‐analysis of randomized controlled trials</title><author>Amer, Basma Ehab ; Yaqout, Yasmeen Essam ; Abozaid, Ahmed Mohamed ; Afifi, Eslam ; Aboelkhier, Menna M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3536-ebc3df04dfe118ff0ab8a87fe5a145bbb50d5ac567c6143a0adbe4a221d44a4f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>AID</topic><topic>Automation</topic><topic>Blood Glucose</topic><topic>Clinical trials</topic><topic>Cross-Over Studies</topic><topic>Daytime</topic><topic>Diabetes</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetes Mellitus, Type 1 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Glucose</topic><topic>Glycemic Control</topic><topic>Humans</topic><topic>hyperglycaemia</topic><topic>Hyperglycemia</topic><topic>Hyperglycemia - drug therapy</topic><topic>Hyperglycemia - prevention & control</topic><topic>hypoglycaemia</topic><topic>Hypoglycemia</topic><topic>Hypoglycemia - chemically induced</topic><topic>Hypoglycemia - drug therapy</topic><topic>Hypoglycemia - prevention & control</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Insulin</topic><topic>Insulin - therapeutic use</topic><topic>Insulin Infusion Systems</topic><topic>Meta-analysis</topic><topic>Randomized Controlled Trials as Topic</topic><topic>time in target</topic><topic>type 2 diabetes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Amer, Basma Ehab</creatorcontrib><creatorcontrib>Yaqout, Yasmeen Essam</creatorcontrib><creatorcontrib>Abozaid, Ahmed Mohamed</creatorcontrib><creatorcontrib>Afifi, Eslam</creatorcontrib><creatorcontrib>Aboelkhier, Menna M.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetic medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Amer, Basma Ehab</au><au>Yaqout, Yasmeen Essam</au><au>Abozaid, Ahmed Mohamed</au><au>Afifi, Eslam</au><au>Aboelkhier, Menna M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Does fully closed‐loop automated insulin delivery improve glycaemic control in patients with type 2 diabetes? A meta‐analysis of randomized controlled trials</atitle><jtitle>Diabetic medicine</jtitle><addtitle>Diabet Med</addtitle><date>2024-01</date><risdate>2024</risdate><volume>41</volume><issue>1</issue><spage>e15196</spage><epage>n/a</epage><pages>e15196-n/a</pages><issn>0742-3071</issn><eissn>1464-5491</eissn><abstract>Aims
This meta‐analysis investigated the efficacy and safety of fully closed‐loop automated insulin delivery (AID) in patients with type 2 diabetes.
Materials and Methods
We systemically searched PubMed, Scopus, Web of Science, and Cochrane Central from inception until April 26, 2023. We included randomized controlled trials (RCTs) comparing fully closed‐loop AID versus conventional insulin therapy. The outcomes were pooled as the mean difference (MD) and risk ratio with 95% confidence interval (CI) in the random effect model. Our primary outcome was the proportion of time in the target glucose range (5.6‐10 mmol/L, 3.9‐10 mmol/L, or 3.9‐8 mmol/L, depending on the study). Key secondary outcomes included the proportion of time spent in hyperglycaemia or hypoglycaemia.
Results
We included seven RCTs (three crossover and four parallel design), compromising 390 patients. Our analysis showed that compared to the control group, fully closed‐loop AID increased the proportion of time spent within the target glucose range by additional 337 min per 24 h (MD = 23.39%, 95% CI [16.64%, 30.14%], p < 0.01), additional 108 min overnight (MD = 22.40%, 95% CI [12.88%, 31.91%], p < 0.01), and additional 258 min during the daytime period (MD = 26.85%, 95% CI [21.06%, 32.63%], p < 0.01). Compared to the control group, the overall time in hyperglycaemia was shortened by 326 min per 24 h (MD = −22.67%, 95% CI [−30.87%, −14.46%], p < 0.01). There was no significant difference between the two groups in terms of overall, overnight, and daytime periods spent in hypoglycaemia.
Conclusions
Our meta‐analysis suggests that fully closed‐loop AID may improve glycaemic control in patients with type 2 diabetes, particularly for those with more challenging diabetes management. Further research is required to establish the feasibility of implementing these systems in clinical practice. [Correction added on 26 August 2023 after first online publication: Under Results, the first sentence “We included seven RCTs (three crossover and one parallel designs)” has been changed to “We included seven RCTs (three crossover and four parallel designs)”.]</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>37567739</pmid><doi>10.1111/dme.15196</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-7787-5508</orcidid></addata></record> |
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| subjects | AID Automation Blood Glucose Clinical trials Cross-Over Studies Daytime Diabetes Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 1 - drug therapy Diabetes Mellitus, Type 2 - drug therapy Glucose Glycemic Control Humans hyperglycaemia Hyperglycemia Hyperglycemia - drug therapy Hyperglycemia - prevention & control hypoglycaemia Hypoglycemia Hypoglycemia - chemically induced Hypoglycemia - drug therapy Hypoglycemia - prevention & control Hypoglycemic Agents - therapeutic use Insulin Insulin - therapeutic use Insulin Infusion Systems Meta-analysis Randomized Controlled Trials as Topic time in target type 2 diabetes |
| title | Does fully closed‐loop automated insulin delivery improve glycaemic control in patients with type 2 diabetes? A meta‐analysis of randomized controlled trials |
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